3. 3 | eyeforpharma: Patient-Centered Clinical Trials www.eyeforpharma.com/clinical
Executive Summary 4
Putting Patients at the Heart of the Trial 4
Patient-Centricity as a Workable Model in R&D 4
The Tipping Point 6
Needles in the Haystack 6
Rising Complexity and Unsustainable Design 7
Lack in Adherence and Protocol Compliance 8
Participant Attrition 9
Getting to Grips with Data 10
Patient Centricity as a New Model in R&D 11
A Changing Context for Drug Development 11
Matching Patients and Research Sites 12
Direct To Patient Recruitment On The Horizon? 13
Abandoning Sites a Step Too Far 14
Patient-Centered Trials: 6 Focus Areas for Innovation 16
1. Social Networks & Virtual Trials 16
Case Study: Pfizer’s REMOTE Trial 16
2. Social Listening 17
3. Managing the Risks of Social Media Chatter 18
4. Incorporating the Patients Voice in Design and Conduct of Clinical Studies 19
Case Study: I-SPY 2 19
5. Improving the Individual Experience During the Trial 21
6. Leveraging Patient-Generated Data & ePRO 22
Case Study: A Practitioner Perspective: Achieving the Benefits of ePRO 23
True Patient Centricity – Vision or Ideal? 25
References 26
Contents
4. www.eyeforpharma.com/clinical eyeforpharma: Patient-Centered Clinical Trials | 4
Patient centric innovation is going to be at the heart of the transformation of
healthcare over the next couple of decades.
– Miles Ayling, Director of Innovation, NHS England
The need for disruptive innovation in pharma has reached a precipice. The low hanging fruit
has been picked as we find ourselves in the era of stratified medicine, escalating R&D costs
and overall patient empowerment. In order to compete, the clinical research industry is
challenged to rethink every aspect of the drug development continuum and to adjust clinical
trials for a notably altered landscape. A number of recent studies have pointed to the rising
complexity and costs of clinical trials. Tufts CSDD found that a fifth of procedures in later
stage clinical trials are solely conducted to collect extraneous data, with the average cost of
these procedures being greater than $1m. On average, study timelines have to be doubled
in order to meet enrolment levels across all therapeutic areas and 37% of all research sites
typically under-enroll patients.1
Putting Patients at the Heart of the Trial
Years of valuable drug development time are lost due to lacking patient engagement.
Enrolment costs account for up to 40% of total US clinical research budgets, so the
widespread delays that are inflating budgets have become a high value problem. Estimates
put the loss of sales revenues a sponsor incurs per month delay in clinical trials at $40m2
.
Against this background, patient-centered drug development has become a hot-button issue.
Drug sponsors are beginning to drive process improvements from the perspective of
patients. In principle, many in the industry are highly engaged with the notion of patient
centricity. Because “it’s essential”, say Francisco Leon and Newman Yeilding, leaders in the
Immunology Development at Janssen. “Patients serve as our inspiration and, in addition,
they play an important part in ensuring that we maintain our focus.”
But are you ready to implement patient-centered clinical trials? What steps have you taken
to bring trials to patients, as opposed to bringing patient to trials? That is what we asked
some of the leading innovators in the clinical research industry for this white paper.
Patient-Centricity as a Workable Model in R&D
We hope to provoke a change of thinking by making a case for a paradigm-shift, altering the
dynamic between pharma and patients. But we also aim to offer concrete advice on how to
make patient-centricity a workable model in drug development. We review successful
strategies to place patients’ needs and concerns at the heart of clinical trials, as well as
cases where such attempts failed. Read further for advice on how to place data generation
in the hands of patients, including a step-by-step reflection on how to achieve the benefits of
ePRO. We also compiled a set of steps that can help boost patient engagement in clinical
trials with the existing site model, and beyond.
Executive Summary
5. 5 | eyeforpharma: Patient-Centered Clinical Trials www.eyeforpharma.com/clinical
Some of the most promising projects we discovered involve utilizing what can be seen as
relatively simple technology in order to boost clinical trial awareness, transparency and,
ultimately, engagement. A key trend is that cross-company collaboration and open
innovation become more common. To give one recent example, Pfizer, Eli Lilly and Novartis
teamed up to help improve ClinicalTrials.gov by matching patients and trials through
healthcare software, including machine readable target health profiles. Pfizer’s use of the
Blue Button standard, launched by the White House, is another inspiring pilot project we will
discuss.
Not surprisingly, the move towards patient centricity has initiated a wave of start-up activity.
CureLauncher is one example, where patients can search for clinical trials before being
connected with potential matches via a series of questions. Listening to the founders behind
such ventures as Patientslikeme, myHealthteams or CureLauncher, the opportunities for
patient-oriented innovation seem truly disruptive. Do they suggest that we have to abandon
the site-centric model to fully realize the patient-centered trial? While challenges and
limitations remain in abundance, we hope this paper can provoke your thoughts, and help
out as a first guide on how patient-focussed innovation can be leveraged across stakeholder
relationships in clinical trials.
In the context of lengthy and complex drug development schedules, regulatory requirements
and ethical constraints, delivering wholesale transformation of the clinical research enterprise
will be a challenging work in progress. But with the blockbuster model in question, and
individual and personalized medicine on the horizon, the need for patient-focused
innovation is after all as inevitable as the opportunities for such change are staggering.
6. www.eyeforpharma.com/clinical eyeforpharma: Patient-Centered Clinical Trials | 6
Individual, personalized, and patient-centric medicine represents the future of clinical
research. We need to write protocols and plan recruitment strategies based upon
individual patient needs and not on a disease class.
– Barb Geiger, Executive Vice President, Clinipace
The complexity, length and cost of clinical trials have grown enormously in recent years.
According to research from Tufts CSDD, the average length of phase III trials increased 70%
between 1995 and 2005, while the typical number of procedures per trial rose by 65%. At
the same time, the number of volunteers admitted plunged 21%, with almost a third
dropping out before completion.3
These are disconcerting statistics, in particular in view of
the development of personalised medicine that is increasingly forcing drug developers to
engage with more segmented patient populations. The pharmaceutical executives
interviewed for this paper expect this trend to lead to increasing enrollment problems and
continued rise in the cost of clinical trials, at a time when the industry is under great
pressure to reduce development costs while replenishing pipelines. In short – the moment to
implement changes to the way clinical trials are designed has come.
FIGURE 1| Changes in Clinical Trials: Resources, Length and Participation
Function 1999 2005 % Change
Median procedures per trial protocol (e.g. blood work, routine exams, x-rays,
etc…)
96 158 +65%
Average clinical trial staff work burden, work-effort units
21 35 +67%
Average length of clinical trial, days 460 780 +70%
Clinical trial participant enrolment rate (% of volunteers meeting trial criteria)
75% 59%
-21%
Clinical trial participant retention rate (% of patients completing trial) 69% 48% -30%
Needles in the Haystack
“We need to find more patients and we need to find them quicker,” says Maik Klasen,
Managing Director at Adivo Associates. One of the most pertinent issues for pharma (that
technologies offer an answer to) is recruiting the right patients in strong enough numbers.
“As we now have more granular application segments and more drugs coming to market, it’s
becoming increasingly difficult to recruit patients in the group you are trying to target,”
Klasen explains. Better recruitment methods will also have to lead to improved cost-
effectiveness. The longer the recruitment takes to adequately enroll a clinical trial, the longer
it will take the drug to come to market. According to research by Langland, a leading global
healthcare communication agency, 80% of trials experience recruitment delays. Tufts’
The Tipping Point
7. 7 | eyeforpharma: Patient-Centered Clinical Trials www.eyeforpharma.com/clinical
studies show that these delays are typically leading to timelines doubling in length. As one
observer has calculated, the cumulative yearly time loss due to enrollment delays across all
trials is 26 years. 4
More than a quarter of a century of valuable drug development time and
that’s just for one sponsoring company. But, as interviewees for this research pointed out,
recruitment delays are intertwined with the growing complexity and patient burden of clinical
trials.
Rising Complexity and Unsustainable Design
As trials have become more complex and expensive, the industry is recognizing that the
conventional way of designing studies will become increasingly unsustainable. Part of the
problem is the high failure rate of compounds that prove promising in phase II trials but
become failures in phase III. While drug developers are well accustomed to achieving a
higher number of misses than hits, there are factors within the trial organizers control that
can support the likelihood of success. These include data capture, protocol design,
recruitment and the competency of those running the trials.
The regulatory requirements for new drug applications have grown to the extent that
companies must now carry out programs on a larger and more complex scale than
ever before. Multi-center, multi-regional trials may easily involve tens of thousands of
patients. One of the biggest concerns with such “mega-trials” is managing the
collection and analysis of great amounts of data. Fortunately, many CRO’s are
adopting Electronic Data Capture (EDC) in order to vastly streamline the process.
The movement towards EDC may be catalyzed by point of care trials, where
seamless data collection and manipulation is essential. Another key issue is a lack of
standardization of EDC, opening the door to errors or losses of important
information. There are also problems with data privacy as clinical trial data cannot be
fully anonymous if it is to be useful to select individual patients for suitable research.
Improving protocol design will be central to increasing success rates of phase III “mega
trials”. Tufts found that 40% of protocols are amended before the first visit while one third
of these changes are avoidable.5 The changes inflate costs, impact the recruitment and
study timelines and complicate the overall analysis.
The US National Cancer Institute (NCI) is attempting to standardize operating
procedures to reduce the timeline of clinical trials. The agency has recommended
changes to policies, procedures and operations and is targeting a reduction in the
activation time for phase III trials from an average of 2 years to 300 days. NCI is
also moving towards standardized laboratory protocols for analyzing biomarkers, as
well as implementing a unified clinical data management system across all of its
sites. The objective is to enable more seamless cross comparison and greater cost-
efficiency.
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FIGURE 2| Rising protocol complexity and burden (all therapeutic areas, all phases) 6
2000–2003 2004–2007 2008–2011
Unique procedures per protocol (median) 20.5 28.2 30.4
Total procedures per protocol (median) 105.9 158.1 166.6
Total investigative site work burden (median units) 28.9 44.6 47.5
Total eligibility criteria 31 49 N/A
Median number of case report form pages per protocol 55 180 N/A
According to Cutting Edge Research, per patient costs have gone up an average of 70%
across all phases since 2008.7
The largest increases were observed in phase IIIa and IIIb
trials in which per patient budgets now top $40,000. One answer to these spiraling costs is
adaptive trials, which involve smaller numbers of patients and have flexible protocols
allowing researches to adapt the trial based on responses during it. Non-essential protocol
points, that are mainly inflating cost, can be dropped or changed more easily.
Another important advancement is the growing readiness among pharma companies to work
together. Precompetitive data sharing has become a way to improve trial procedures;
innovation is driven by new collaborations. For example, Merck has recently worked
successfully with AstraZeneca on cancer markers, as well as GSK, Eli Lilly and Roche on
diabetes. Notable industry-wide collaborations include Transcelerate, the Clinical Trials
Transformation Initiative, the Critical Path Institute, Project Data Sphere or the Accelerating
Medicines Partnership (AMP). Such alliances and consortia are crucial in order to address
rising challenges related to clinical trial enrollment and efficiency, Miles Ayling, Director of
Innovation at NHS England, tells eyeforpharma. “I’m starting to see a willingness to
collaborate but it will take time to influence the ten or fifteen year development cycle for
new pharmaceuticals,” Ayling says.
Lack in Adherence and Protocol Compliance
As trial protocols have become more arduous in recent years (and are set to continue along
this trend), the risk of patients not complying with them is on the rise. There are multiple
knock-on effects of a discrepancy between protocolled behavior and actual participant
behavior.
FIGURE 3| Risks of protocol non-adherence
Significant study delays – recruitment will have to be prolonged to maintain an adequate sample
size to power the study;
Increased costs – due to extended resource utilization of medicine, labs, personnel and
processing;
Failure to win approval – missing data may call into question reported results, as drug safety may
be overestimated while risks, adverse effects as well as medication effectiveness could be
underestimated.
9. 9 | eyeforpharma: Patient-Centered Clinical Trials www.eyeforpharma.com/clinical
The lack of adherence to study rules is hardly surprising, as the founders of patientslikeme,
the patient powered disease platform, claim in a recent comment in the British Medical
Journal:
The social contract of the randomized controlled trial is imbalanced: patients adhere
to arduous protocols, are randomized to placebo, and are blinded to their health
status. Although most participants (>90%) would like a lay summary of results, only
a minority (<10%) receive one, with the remainder left with the option of paying
around $30 (£18; €22) to read the results once the study is published in a peer
reviewed journal.8
In a number of areas, patients are expected to perform the day-to-day management of the
study protocol themselves. That may often be burdensome. Moreover, the development of
social media platforms has enabled participants to link up and share their experiences and
data, sometimes leading to protocol violation on the basis of shared information. If pharma
fails to address the issues in the future, the authors argue, “a phase III study might be
rendered scientifically null by a critical mass of participants making intentional protocol
violations on PatientsLikeMe, Facebook, or Twitter.”9
Participant Attrition
Retaining patients in clinical trials has proved to be an enormous challenge. According to
Tufts, 30% of trial participants drop out before completion. Almost a third of all of the work
with patients during a phase III clinical trials is effectively lost, that notion is – from a drug
development standpoint – highly alarming.
There are positive and negative factors influencing the outlook for patient retention. On one
hand, personalized medicine should instigate a new wave of trials that are highly targeted to
certain patient groups. Over the years, one of the drivers of participant attrition in clinical
trials has been the perception of a lack of benefit from the trial to remain part of it. With
highly targeted studies, medical benefits should improve and hence the incentive to “stay in”
may become more obvious.
The industry must start to identify subsets of patient populations which respond
particularly well to the drugs in development. Umbrella diagnoses, much beloved by
regulators, are no longer appropriate and blockbuster drugs based on these
misnomers will go the way of the dinosaur.10
– Clinical Trial Leader, Novartis Consumer Healthcare
On the other hand, patients are less and less willing to endure trials that are not designed
with their needs at the heart. Based on more than three decades of drug development
experience, Colin Scott, and clinical leaders like him, advocate very simple improvements.
Basic changes can make a huge impact, such as actually arranging convenient transport for
trial participants, rather than providing a stipend at the end. In essence, to become more
patient friendly, clinical trials have to regain resemblance with successful clinical practice.
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Getting to Grips with the Data
Recent years have seen the manner in which data is captured from patients change
dramatically, though the available technology is still massively underutilized compared to
what’s possible. The advent of ePRO has enabled sponsors to reduce the data collection
burden on patients, leading to improved data quality and patient experience. There are also
benefits related to adherence. Compliance with paper-reported patient outcomes is
commonly found to be less than 30%, while ePRO have a rate of more than 89%.11
Pharma
and clinical trial organizations must get to grips with data fast: streamlining the process by
which it is collected, analyzed and shared. This will lead to significant benefits for patients
and the industry, though it creates new challenges too.
Across all of these areas: recruitment, retention, trial design, patient compliance and data
capture, the need for pharma to innovate is now clear and well understood. The industry has
reached a tipping point and in order to successfully deliver drugs for future generations,
clinical research and development must shed old habits.
11. 11 | eyeforpharma: Patient-Centered Clinical Trials www.eyeforpharma.com/clinical
In terms or disruptive innovation, one could say that in order to become patient centered,
every aspect of the clinical trial journey has to be reformed. There needs to be a paradigm
shift as the transformation requires a re-thinking of the clinical trial process as we know it.
FIGURE 4| The paradigm shift towards patient centricity
Established Model Patient-Centered Clinical Trial
Linear, sequential Multi-directional, interactive
Compartmentalized Open
Insular Integrated
Vertical ownership and centralized risk Horizontal ownership and shared risk
Rigid, transactional, reactive Flexible, adaptive, proactive
Proprietary clinical data at the core Patient experience at the core
Focus on great science Focus on great and feasible science
Participant as study subject Participant as partner, lead customer
* Adapted from Getz, K. (2014). Conference Presentation. Tufts Center for the Study of Drug Development.
A Changing Context for Drug Development
By and large, patients do not join clinical trials to help pharma develop new medicines and
bring drugs to market. In the past, clinical trials have been understood purely in terms of the
scientific (data) value they are designed to deliver. This calls for a reframing of each of the
objectives of clinical trials in the context of participants needs (primarily as patients seeking
treatment). Colin Scott illustrates the difference with an example from his work in pulmonary
medicine at Forest Research Labs: “Our first drugs were bronchodilators so we became used
to using pulmonary function parameters as primary variables in all respiratory conditions.
These show activity, not therapeutic utility. The disconnect is clear, patients with COPD will
tell you they are breathless – not that their FEV1 is down 14%.”
The move among payers toward prioritizing the real world value of drugs has further
implications for the conduct of clinical research. The extent to which people’s lives have been
changed in tangible ways is increasingly becoming a differentiator for successful market
access. Answering questions such as whether or not a drug will get patients back to work
can be one simple example of change that really matters. “It’s no longer just about who can
get one inch past some finish line, the objective is to really demonstrate that the treatment
is going to work for a long time for enough people and on balance is going to be worth it,”
summarizes Paul Wicks of patientslikeme. Value is defined by patient experiences and given
the increasing demand for incorporating quality of life tools, PRO and softer endpoints,
clinical trial design needs to reflect that overarching trend. By engaging the patients more
effectively and sustainably, development and approval pathways can be accelerated.
Patient Centricity as a New Model in R&D
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FIGURE 5| Patient- centered clinical trials: Each aspect driven by patient needs
Matching Patients and Research Sites
Timothy Garnett, Chief Medical Officer of Eli Lilly, is worried about the fact that the majority
of patients and investigators who take part in studies, do so only once. “How can we
become more patient and investigator friendly in an ever increasingly competitive
environment?”, Garnett asks in a recent interview12
. One of the ways his company addressed
this challenge is by teaming up with J&J and Merck to provide investigators with valuable
clinical practice training information. Garnett also notes that there are a number of ways the
trial experience should be improved from the patient perspective. One of these is to mitigate
the placebo effect; given that the placebo is highly unappealing for those seeking
therapeutic benefits. New statistical methods can help to limit the number of patients who
this affects. “These models allow you to create a very large virtual placebo group so the
actual placebo group can be small,” says Garnett.
In November 2013, Pfizer, Eli Lilly and Novartis signed up as partners in an open innovation
initiative to improve ClinicalTrials.gov. The goal is to make the website more effective at
matching patients to trials. The project marks an important progression from the era of
manually identifying suitable clinical trials. By using electronic health records (EHRs), the aim
is to devise a target health profile for each clinical trial that is machine-readable, so that
software can match patients to specific inclusion criteria.
Further, patients with profiles on Blue Button, the Whitehouse’s new patient data portal, will
be able to search for studies. Using the Blue Button standard, patients are empowered to
use their individual electronic clinical data to improve their overall health and wellness, from
sharing data with health care providers to powering clinical risk assessment tools.
Patient
needs
Protocol
design
Pre-trial
planning
Long-term
impact
Trial
experience
13. 13 | eyeforpharma: Patient-Centered Clinical Trials www.eyeforpharma.com/clinical
Direct To Patient Recruitment On The Horizon?
These developments open up further advancements. Right now it’s matchmaking from a
patient-driven perspective. For instance, Blue Button only helps to match certain patient
demographics to a certain trial, providing a map where users can look up a trial in their
neighborhood. Ultimately though, this tool could be used by a central organizer in the
reverse.
Organizers who have access to the portal could try to find patients who would be suitable for
a trial and reach out to them directly. This is highly targeted as there no longer is the need
to post to a university hospital website, recruitment center, etc. Instead an EHR environment
is used. This type of process could be useful given the development of personalized health,
as well as helping to find patients in certain demographics.
FIGURE 6| Opportunities for direct to patient recruitment
Any change from web-based clinical trial portals, such as being used to receive data, to
pushing data out to physicians, payers or even patients directly, while technically feasible, is
a long way off. The question is who is more active: Is the patient actively looking, is the
physician searching or is the research organization trying to recruit patients to get the
clinical trial on its feet. At present, regulations restrict direct recruitment of patients where
sponsors actively identify them through EHRs. With data privacy concerns growing more
acute on a global scale, progress in this area will likely be gradual. However, the tools now
exist to open up new avenues of patient recruitment. The crucial question for drug
developers is whether they will be allowed to make an attempt to recruit patients, even if
they can identify them. While pharma would like to be proactive in this manner, sensitivity to
data privacy is restricting such activities. Arguably, concerns regarding patients being
contacted by trial organizers are well grounded – and patients have a right to privacy.
There could even be a second wave of innovation borne from the advances in patient-driven
clinical trial portals, trying to match the right physicians to certain clinical development
initiatives. By connecting the right opinion leader to clinical trials, pharma companies could
attract particular knowledge to their initiatives. They would use similar tools to segment key
opinion leaders and match them with the precise clinical development profile.
CRO Patients/PhysiciansClinical trial portal
Patients and physicians identify suitable trials
via web portal, supported by software
CRO’s or pharma companies can reach out
to patients by identifying matching EHRs
14. www.eyeforpharma.com/clinical eyeforpharma: Patient-Centered Clinical Trials | 14
Abandoning Sites a Step Too Far
Several contributors to this paper acknowledge an overall movement in clinical innovation
away from a site-centric model towards a patient-centric model. The fundamental objective
is to make clinical trials accessible to a larger community. The Novartis trial run at Walgreens
is the most prominent recent example of this. In 2013, Novartis and Walgreens announced a
partnership to run trials out of pharmacies, launching a study that should ultimately recruit
up to 12,000 patients out of 300 sites across the US.
The study is an example of pharma learning from the Pfizer virtual study, which “failed” in
the sponsor’s ambition to collect data directly from trial patients in 2012 (see case study
below). Industry observers have debated whether going “direct to patients” could be a step
too far at present. Yet, there are multiple care setting in between traditional research sites
and the patients’ home that can be leveraged.
By bringing the study site closer to the patient, the objective is to reduce the burden on
participants and to boost enrolment, adherence and retention. Adherence can here be
understood as the level of correspondence between protocol-required behavior and study
participant behavior – such as following treatment regime, visit attendance, assessment
completion, reporting as required, etc.13
FIGURE 7| Activities moving away from the research site 14
The benefit of such a disruptive approach is that it opens up a pool of patients in most areas
of the US where patients would usually have to travel long distances to get to a clinical trial
center. Rather than travelling 50 miles to a trial site, they have to go a comparatively short
distance to their nearest pharmacy. Access hurdles for patients are lowered by making the
trial more convenient.
VenuePeople
High Cost
High Skill
High Burden
Low Cost
Low Skill
Low Burden
Sites
Tech
Pharmacies In-home On person
Bring the trial closer to the patient
Doctors Pharmacists Nurse or self Self
EDC Adjusted EDC
Connected
Devices
Mobile /
Wearable
15. 15 | eyeforpharma: Patient-Centered Clinical Trials www.eyeforpharma.com/clinical
As simple as this kind of set-up sounds in principle, it has critical limitations. This model is
only suitable for clinical trials where a patient can be checked up on in a pharmacy setting.
What may work well for a longer-term chronic disease trial in asthma, does not work for a
treatment in oncology. Tight laws in Europe limit the potential for a physician to carry out a
follow-up (or a nurse in an ambulatory care setting).
Several restrictions require that clinical trials are centralized and will remain so for a
considerable period of time. As sponsors are not ready to carry out clinical trials in the
patient’s home – and will not be for the foreseeable future – it is even more essential to
address issues in collaboration with investigators so as to improve convenience for patients
and reduce the number of under-enrolling research sites.
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1. Social Networks & Virtual Trials
No one would dispute the value of the Internet in allowing patients to learn about a disease,
understand what risks actually mean and organize in self-help groups for more effective
prevention and drug adherence. However, the use of social networks as a recruitment tool
for clinical trials has yet to demonstrate tangible success. Pfizer’s “REMOTE” trial was one of
the first attempts of a large sponsor in this area, and it failed partly due to patients’
unwillingness to respond to recruitment efforts via informal sites such as Facebook. Social
media are currently being used to recruit patients in only about 11% of all trials15
.
CASE STUDY A | Pfizer’s REMOTE trial
Trial: Research on Electronic Monitoring of OAB [Overactive Bladder] Treatment Experience
Treatment area: Overactive Bladder
Sponsor: Pfizer
REMOTE was the first randomized clinical trial in which patients could participate from home via
mobile phones or the web. The objectives were to save time, gather higher quality data and to boost
patient compliance. The idea was that patients could adhere to the protocol remotely, with drugs
being delivered to them by mail. The 2011 study followed a traditional trial of Detrol LA, the
antimuscarinic drug being tested for symptomatic treatment of urinary incontinence.
The original aim of the trial was to attract 600 patients from 10 states in the US. A cartoon video was
posted to recruit patients to the trial, educating them on how to apply and partake. Applicants were
to be taken through an online process of qualification before getting enrolled. Patients were advised
how to self-report their responses to treatment. Physicians were involved to help support patients
through the trial, while investigators oversaw the data collection and analysis. Patients were meant
to be partners in the research, not only able to access the study results but also their own clinical
data, which would be made available via personal health records. The trial was halted in 2012 due to
largely insufficient patient enrolment.
While the trial did not make it off the ground, Pfizer identified a number of valuable findings from
carrying out the project. They had found a way to successfully engage with large numbers of
potential trial recruits online, and had developed an effective informed consent methodology for the
new medium. The trial was also a success from the standpoint of developing patient-centric data
capture techniques. Head of Clinical Innovation at Pfizer, Craig Lipset, noted that while he was
disappointed with the outcome, the project “does not represent a failure for, or withdrawal from,
the use of the internet or social media for patient recruitment. We routinely use the Internet as a
channel for recruitment in our studies and will continue to do so wherever it is appropriate.”16
Key lessons
Pfizer used social media channels like Facebook, which though successful in generating
awareness of the trial, fell down at the actual recruitment stage. A potential reason later
identified was that patients did not trust online sources with personal information of this nature.
Another key issue was that Pfizer was testing a number of innovations at once. Disruptors should
consider a one-thing-at-a-time approach in the future.
Pfizer admitted that for some diseases and certain levels of acuteness, it is better to use offline
channels to recruit than online channels.
Patient-Centered Trials: 6 Focus Areas for Innovation
17. 17 | eyeforpharma: Patient-Centered Clinical Trials www.eyeforpharma.com/clinical
For the time being, most drug sponsors see the potential of existing social networks in
raising awareness of clinical research. Novartis ran a short pilot using Twitter, through its
@novartistrials account, to publicize US clinical trials. Results of this have not been released
and the account updates cannot currently be viewed. In turn, Pfizer has dedicated a
YouTube channel that currently features information about a teenage smoking clinical trial
and another on lupus.
Experts also advise caution, however, noting that other channels may be more effective to
reach the right patients. According to research by Blue Chip Social, “fewer than 20% of e-
Patients were very comfortable receiving clinical trial messages via Facebook wall or Twitter
profile.”17
In the meantime, drug sponsors are expected to become trusted members of
social media communities, sharing information that is helpful based on an on-going
conversation, but avoiding “unsolicited” messages about enrolling trials.
Mobile apps are one opportunity for pharma to reach out to patients interested in
participating in a trial. For example, Novartis’s Clinical Trial Seek app for Apple and Android
smartphones sources potential cancer clinical trials in the US from the National Institutes of
Health’s clinicaltrials.gov database, allowing patients and physicians to search for local trials.
2. Social Listening
The clinical industry is increasingly attentive to the concept of social listening: a way to
monitor and analyze social media by extracting data from blogs, social networks, message
boards, wikis, Twitter and news sources. With over two billion people online, and one in four
people in the world using social media, social listening has become an essential instrument
to gather customer intelligence in many industries. Melissa Jean Mottolo, Patient Strategist
Associate at Genentech, advocates mining patients’ interaction where they congregate online
for clinical trials: “By listening to the patient and caregiver, one can start to understand the
patient’s voice, which in turn can have a positive impact on the trial design and recruitment
strategy”, Mottolo argues. “We are in business to serve patient’s needs, so why not listen to
them?”
There are hitherto very few indicators of drug sponsor’s systematic use of social listening for
study recruitment. Eileen O’Brien, Director of Media & Engagement at Twist Marketing,
points to an inspiring example of what a successful and targeted follow-up can look like. In
2009, the American attorney Melissa Hogan received the diagnosis that her son Case has
Hunter syndrome (Mucopolysaccharidosis II). To engage with others in the disease
community, she began a blog to document their journey through every-day life, the health
care and educational system. “They had to travel a long way from their home, out to Raleigh
to have an infusion. It was very risky but as it’s her son’s chance to stay alive so she blogged
about the whole thing,” recalls O’Brien. Case entered into a clinical trial in 2010. “Before
other mothers would enroll their children, they spoke to her,” says O’Brien. Recognizing the
position that Hogan held as a key opinion leader for patients, the study organizer reached
out to her and other mothers to help “fill” the trial, a study that could not have started
without the screening and leveraging of social media.
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It is fair to say that the intersection of patients and social media has been a game changer in
the healthcare industry. One organization innovating the space is myHealthTeams. The start-
up creates specialized social networks for patients with chronic conditions and their
caregivers. One of these communities is MyAutismTeam, which has registered more than
52,000 active parents since its launch in 2011. The goal of my MyHealthTeams is to engage
patients in a setting they are familiar and comfortable with. As Co-founder and CEO Eric
Peacock explains, “most health sites don’t actually help these people connect with and learn
from others who have been in their shoes, and the majority feel like they’re trying to re-
invent the wheel.18
MyHealthTeams builds experiences that look and feel more like a
consumer social networking site than a healthcare platform, but at the same time provide a
very dedicated forum for those wanting to discuss the disease with others who are similarly
affected.
Like patients who use therapies already on the market,
clinical trial participants are increasingly logging on to social
media to share and discuss their trial and disease experience.
One of the most prominent examples has been “Gilenya and Me: My Story of Being an MS
Patient, a Hypochondriac and a Guinea Pig.” Jeri Burtchell started the blog in 2007 to
document her involvement in the trial of Gilenya, a multiple sclerosis product by Novartis.
She began sharing specific and detailed information online. It was the first time for a patient
to report on a clinical trial from start to finish in social media. Thought leaders in pharma
took note and Craig Lipset, Head of Clinical Innovation at Pfizer, even reached out to her
directly. The blog that started with a handful of followers has now moved to a private
Facebook page with more than 2000 members. Burtchell has since become an advocate for
study participants to speak up about their experiences during a clinical trial. However, along
with her colleagues in pharma, she realized that the praxis of such peer discourse could have
severe complications for the conduct and integrity of the research. “I learned about the
possibility of unblinding from my lead investigator” Burtchell says. “The lesson stuck.”
3. Managing the Risks of Social Media Chatter
In the Oscar-winning biographical drama Dallas Buyers Club, set in the 1980’s, a group of
AIDS patients comes together to share their experiences (and frustration) with a new
medication in a clinical trial. They form a network and ultimately begin to sell an alternative,
unapproved drug combination. Fast forward to 2014, and patients in clinical trials are better
equipped than ever to connect with one another and share sensitive information about
clinical trials, potentially jeopardizing the research process. According to Pfizer’s Craig
Lipset, “this sharing of information has its benefits, but it can also undermine the scientific
integrity of medical research.”
In a recent report for Clinical Informatics News, Maxine Bookbinder gives a potent illustration
of the predicaments for investigators when it comes to engaging online patients19
:
A patient who identifies himself as Hockeystud36 complains of a monstrous
headache following his last trial dosage. Is this patient in the current study? Or is
this report from a previous trial? Is the trial randomized, and did the patient take the
study medication or placebo? Did he take it as prescribed? Even though the
19. 19 | eyeforpharma: Patient-Centered Clinical Trials www.eyeforpharma.com/clinical
investigator does not know who Hockeystud36 is, he still has an obligation to report
the headache. But, what if the headache was already reported? Was it, in fact, due
to the medication? Every infinitesimal safety event must be reported, despite the
ability to verify its authenticity.
In a trial of, say, 200 participants, one or two safety reports, verified or not, can
skew results. After Hockeystud36 reports his headache, Honeybun_01 and three
others may respond that they, too, had headaches. The research sponsors don’t
know the patients’ identities, if they’re all in the same trial, or whether their
headaches were real or suggestive, psychosomatic responses.
Joe Kim, Director of Clinical Innovation at Shire, reveals that his organization has faced this
issue directly. “We needed to find a way to help patients talk safely about their clinical hopes
and experiences”, Kim says. He partnered with UK agency Langland and CISCRP to create
“Speak out, but speak smart”, a series of animated clips to guide patients on “how” to talk
about their trial experience. The program is one attempt to educate patients on inadvertent
un-blinding and other risks when deciding on what to share online.
Social media are not going away and the industry is now incorporating the reality of social
sharing into clinical trial planning. In essence, trial participants should be encouraged to
engage with each other in collaborative, supportive means. Sponsors need to be
experimenting with different ways to allow patients to share information safely while
preserving the integrity of the trial. Approaches include distinguishable user names, private,
monitored discussion boards to ask questions to moderators or understandable guidelines,
setting out mutual expectations. It all circles back to how pharma should respond to the
interactive, empowered and virtually-vocal patient.
4. Incorporating the Patients Voice in Design and Conduct of Clinical Studies
As the clinical research industry is gradually catching up to patient empowerment,
companies now involve patient advocacy groups more systematically in order to review the
endpoints, making sure the trial will work, uncover any hidden costs and improve patient-site
communication. It’s about having the patient in mind from the very beginning of planning a
trial.
Before a trial begins, organizers should thus always liaise with representatives from local
stakeholder groups to seek their input on the design and to foster their sense of ‘ownership’
of the trial. A feasibility study should be undertaken to ascertain likely numbers of eligible
participants from each potential site. By putting the availability of patients at the center of
trial site initiation, expenses can be saved and a wider spread of suitable patients can be
tapped across multiple sites.
Moreover, “What if patients were viewed as collaborators in drug development, not sources
of data?”, asks Tom Krohn, Director of Clinical Open Innovation at Eli Lilly. Krohn is an
advocate for redefining patient engagement in clinical trials from a consumer perspective.
“What if they could explore what it was like to be in a study before they visited the site?”
Together with his colleagues at Eli Lilly, Krohn has sought to transform the way patients are
involved in clinical research by integrating trials closer into patient lifestyles, as opposed to
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the other way around. In this vein, the company has improved the trial matchmaking
processes, altered the tone and presentation of communications with patients and tried to
integrate the patient voice into study design. The team also explored opportunities to
redefine and innovate informed consent processes with consumer-centered approaches.
While involving patients more thoroughly is now a widely accepted approach, it was only last
year that the FDA increased patient participation in the regulatory process. According to
most trial managers consulted for this paper, patients are thrilled to be invited to the table.
CASE STUDY B | I-SPY 2
Trial: Serial Studies to Predict Therapeutic Response with Imaging and Molecular Analysis 2
(I-SPY 2)
Treatment area: Breast Cancer
Sponsor: QuantumLeap Healthcare Collaborative
Partner: Foundation for the National Institutes of Health (FNIH)
I-SPY 2 was an adaptive trial designed to rapidly and efficiently identify investigational agents
likely to succeed in phase III clinical trials, as well as information about patients each agent will
help. The I-SPY 2 trial involved early and often engagement with patient advocates, with deeper
involvement of a far greater number of advocates than previous trials.
Paul Wicks at PatientsLikeMe testifies to the innovative involvement of patient advocates in the
trial. “They had 40 patient advocates involved in the design of this study and they voted in
scientific oversight committees.” This reflects a true spirit of patient empowerment, rather than
compliance driven tokenism. The key difference compared to symbolic patient-centered
initiatives is that advocates were given specific responsibilities and had real power. Advocates
helped to create brochures, a website and a DVD to inform patients about the trial. The
Foundation for National Institutes reported that advocates, “worked to ensure that the design
of the trial is as convenient for patients as possible.”
Objectives
According to Jane Perlmutter, the lead patient advocate of the I-SPY 2 study, the key objectives
for patient advocates in the study were:
1. Sensitizing researchers to issues that influence patient recruitment, retention and
satisfaction;
2. Providing a consumer perspective on ethical issues;
3. Focusing on toxicities as well as benefits;
4. Encouraging quality-of-life add-ons;
5. Encouraging collaboration across disciplines and among stakeholders, adding a personal face
and sense of urgency to research efforts;
6. Increasing public understanding of science.
21. 21 | eyeforpharma: Patient-Centered Clinical Trials www.eyeforpharma.com/clinical
Key lessons
True involvement of patients means giving them real responsibilities that influence how the
trial is run
Patients should be involved right from the early stages, even before a trial starts, in order to
ensure the outcomes and procedures will be truly patient-centered
Patient feedback should be sought and incorporated throughout the trial
5. Improving the Individual Experience During the Trial
Practically improving clinical trial experiences might mean taking rather straightforward
steps. For example creating a video to explain clinical risks or getting feedback on the length
of forms so that they are easy to understand. Communicating with patients in an effective
way is critical, as trials involve sharing complex information at a time when participants and
their loved ones are at a highly vulnerable point. Organizers should share lot more
educational information with patients, says a recruitment manager at a leading pharma
company, identifying this as one of the main issues emerging from patient feedback. The
key is to do it in a way that patients can easily understand, while being transparent and
respectful.
FIGURE 8| Patient trial experience as the core: Determines recruitment, adherence, retention
More study visits means more time off work for either patients or caregivers. There are other
hidden costs that may not even be obvious but can have a significant impact on a patient’s
overall experiences, such as sitting in a waiting room without hospital Wi-Fi. For many trials,
the accumulation of slight inconveniences makes patients evaluate their participation in
terms of overall costs and benefits. Unless the patient is in a very desperate disease status,
such as with motor neuron disease or cancer, those small factors can become decisive. “You
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can’t just view participants as either in or out”, Paul Wicks of patientslikeme notes,” it’s not
as though after they sign an informed consent, they are yours for the next two years.”
Across every touch point, patients make an active conscious choice: Every time they take a
pill, fill out a questionnaire or come in to the hospital for a study visit.
Although monetary incentives in healthcare are controversial, surveys suggest that offering
modest reimbursement for the patients’ trouble, a practice with a long tradition, can be
highly effective to ensure participation. The first to offer financial compensation for research
participation was Walter Reed, who in 1901 led the team that postulated and confirmed the
theory that yellow fever is transmitted by a particular mosquito species, rather than by direct
contact. He paid volunteers $100 in gold for participation, and offered a bonus of $100 for
successful infection with yellow fever, payable to family in the event of death. Nowadays,
24-80% of research organizations and academic medical centers pay at least some
participants. Sponsors should examine the influence of payment preference on study accrual
and retention rates, and optimize payment schemes for study start-up in particular for
international trial sites.
6. Leveraging Patient-Generated Data & ePRO
Placing data generation in the hands of patients may yield significant benefits for the
conduct of clinical trials. “If you allow for more information to be generated by patients, it
could help collect data in a shorter amount of time. You might even be able to develop the
data you need for submitting new drug applications more efficiently. One of the issues with
giving more power to patients to generate data is that, we fear we’ll find more adverse
events”, says a senior executive interviewed for this paper. This will, however, improve the
efficacy of drugs.
In terms of patient-reported outcomes systems, there are very clear advantages of electronic
over paper-based tools. Although additional training for study sites is required, the use of
ePRO technology offers cleaner data capture so study coordinators can spend more time
with their study participants and enjoy higher patient compliance. ePRO eliminates missed,
illegible or illogical responses. Study coordinators are exempt from manual calculations, and
from spending precious time reviewing or deciphering patients’ handwritten diaries.
Efficiencies are realized with accelerated data availability from electronic capture, including
the elimination or reduction of missing data. Data by an ePRO is collected in real-time and
within the context of the patient’s life. The ePRO collection of diaries and questionnaires
improves the data quality for analysis and trial management.
Today, the focus of the debate is on the choice between dedicated, increasingly clever but
easy-to-use devices, and the latest trend of patients being allowed to use their own
smartphones as an access point to ePRO solutions. The cost of fully provisioning as well as
managing large quantities of devices across the globe can be avoided by the device
independent approach. In essence, the issue is no longer focused so much on the hardware
but rather on the software and the app that links patients to it. Whether sponsors wish to
continue providing dedicated devices or choose the BYOD model – it seems certain that
23. 23 | eyeforpharma: Patient-Centered Clinical Trials www.eyeforpharma.com/clinical
ePRO processes will continue to adapt and improve as the technology becomes more widely
adopted in clinical research activity.
CASE STUDY C | A Practitioner Perspective: Achieving the Benefits of ePRO
Darja Turner, lic.phil.I, Clinical Psychologist
In a recent Phase II trial, we chose an ePRO system that offered a number of advantages to address
the complexity of this trial. The system provided to study participants included mobile eDiary device,
a Wireless Pak for transmission and in case the wireless transmission failed, a TeleCradle for
analogue transmission. The mobile eDiary device was portable and lightweight, with a compact
screen.
Two devices were ordered for each of the investigative sites since expectations were to have no
more than two active patients enrolled at each site at any one time. The working plan was that if one
subject did not meet the criteria and had to be discontinued, the device would be reassigned to a
new patient. However, the initial plans were inadequate and it became necessary to re-order
additional devices; in some cases, many more than two per site.
The study sites had several responsibilities for monitoring patients once they were enrolled. During
training, site investigators or study coordinators were required to demonstrate an understanding of
how to work with the eDiary and to answer questions about the device. Each patient was expected
to receive 15 to 30 minutes of training from the study coordinator on how to use the eDiary.
Initially, many patients called the vendor’s Support Center for eDiary training and questions, either
because they didn’t remember some of the instructions once they had departed from the study site
or the initial training wasn’t intensive enough. The solution was to develop a study-specific
Troubleshooting Guide to address the most common questions. It took approximately 10 days while
waiting for the guide to be approved by the IRB.
Once patients received their ePRO device from the study coordinators or investigator, they were
required to complete their diaries every day for two weeks. At the first visit following the initial
screening, patient compliance was assessed with the touch of the button on the ePRO LogPad. With
three separate questionnaires distributed at different points within the study, the potential for
human error (and disseminating an incorrect questionnaire) was real. The ePRO system provided the
right questionnaire to each patient at the right time and helped mitigate the potential for human
error. If a patient withdrew early or completed the study, a final questionnaire was provided at the
time of study withdrawal or completion.
Success factors: Optimize your ePRO Imitative
The ePRO Vendor
Select your ePRO vendor early and take time to understand their processes, document flows and
timelines. Get to know your Project Manager and Coordinator to establish who is responsible for
what at each stage of the study, so handoffs are smooth. Leverage the ePRO vendor’s years of
operational experience by including them during protocol writing and all planning phases so
reasonable endpoint data and instruments (according to FDA guidelines) are used for protocol
development.
Any modification to existing questionnaires requires more time to prove fit for purpose. If a
combination of collection solutions is used, such as IWRS and ePRO, consider integrating these
devices to eliminate the chance of manual errors. This will deliver fewer errors, reducing
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frustration and costs. However, some integration may increase the trial timeline, so plan
accordingly.
The Clinical Trial Team
Assemble the core team early. Your data management, site management and biostatistics
colleagues need the same understanding of timelines as you to facilitate rapid approval of
documents such as Confidential Disclosure Agreements (CDAs), ePRO contract, Statement of
Work (SOW), Data Summary (DS) and Data Transfer (DT) Specifications and User Acceptance
Testing (UAT).
Review the ePRO Requirements Document carefully, as this determines what the trial will look
like, and all that is required at each step along the way. Any change to this document later, even
a minor modification, has an impact on the trial timeline. Changes require that the ePRO vendor
program and test the trial changes in all languages.
More extensive protocol amendments can disrupt budgets and timelines. A thorough
Requirements Document review allows for solid initial software deployment and avoids
subsequent updates. Test the ePRO device extensively during the user acceptance testing and
document the findings. These test results will be needed later for the test data transfer.
The Investigator Sites
It’s important to confirm and verify each site’s mobile network and signal strength before
determining which transmission devices to ship to the site for an ePRO study. If possible, select
“technology-loving” sites and study coordinators. If the site is ePRO naïve, be sure the study
coordinator is familiar with electronic devices (especially computers and mobile phones). Consider
adding an extra study coordinator if the study coordinator is not comfortable with technology.
Study coordinators are training the patients enrolled in the trial, so plan adequate time (preferably 2
hours) for the investigator meeting. The better they know how to use the eDiary, how to charge it
and transmit data, the better the patients will be trained. Better training means higher compliance.
Keep sites involved and informed. Remind them to check their online reports daily. It is
important to monitor the eDiary battery level and patient compliance. Remind study
coordinators that the sponsor can review a Support Center report. Consider publishing a
monthly newsletter featuring anonymous questions/answers about the trial, or the most
frequent questions addressed by the vendor’s Support Center. This is a very effective reminder
for sites that are reluctant to ask questions of the sponsor
Ideally, it takes six-eight weeks to set up and troubleshoot an ePRO system, not counting legal
review, so allow plenty of time for contingencies. Undoubtedly there is more upfront work required
to use an ePRO System but in the end proper planning can save time, money and frustration. An
experienced ePRO vendor will be familiar with data transfers, communication, training and
integration of the ePRO with IWRS/IVRS, so it’s important to pick a knowledgeable partner. As more
outcomes data are required for claims by regulatory agencies and payers, ePRO is the way of the
future.
Darja Turner, lic.phil.I, Clinical Psychologist, studied Clinical Psychology at the University of Basel
where she completed her training in 2001. Her experience includes management of numerous trials
including the first ePRO trial of a leading pharmaceutical company. Ms. Turner’s views and opinions
expressed in this contribution are personal and should not be attributed to any organization.
25. 25 | eyeforpharma: Patient-Centered Clinical Trials www.eyeforpharma.com/clinical
A prevalent argument in the call for patient-centered clinical trials is that initiatives in the
areas outlined above rarely go far enough. As important as they are as initial focus areas, we
agree that these may eventually only result in incremental steps toward a more fundamental
shift in the conception of drug development. Furthermore, patient centricity and patient
engagement have become buzzwords in pharmaceutical business speak while many primarily
talk about an updated approach to patient compliance. However, true patient centricity asks
about how pharma can better comply with patients’ needs rather than asking them to
comply with pharma’s needs. Nevertheless, the clinical research industry has recently
demonstrated a strong desire to engage with patients on an equal footing and to take
innovative steps to incorporate patient empowerment across the value chain of clinical trials.
Sherry Arnstein’s ladder of participation could be a thought-provoking instrument to reflect
on the role pharma offers to the patient in clinical trials. The ladder identifies a variety of
levels of public participation, where at the top level, citizens (patients) are given true control
and power over (health) outcomes.
FIGURE 9| Arnstein’s ladder of citizen participation20
Although patients will likely never be in full control of clinical trials, the most successful
examples of patient centricity still place patients at the very top – treating them as lead
customers, involving them in trial design and giving their decisions actual weight. Leading
sponsors such as Pfizer, Eli Lilly, Janssen or Novartis have all demonstrated a keen vision to
transform clinical trials and to place patients at the core of their research operations. This
shift in mind-set may be the most important first step, which can help fuel the next wave of
patient-focused clinical trial innovation, support the industry to produce more innovative
therapies under a more sustainable and create a future-oriented long-term business model.
True Patient Centricity – Vision or Ideal?
26. www.eyeforpharma.com/clinical eyeforpharma: Patient-Centered Clinical Trials | 26
1 Tufts Center for the Study of Drug Development (2013). 89% oftrials meet enrollment, but timelines slip, half of sites under-enroll.
Impact Report Vol. 15, No1. Jan/Feb.
2 Mintz, C. (2010). Social Media’s Impact on Clinical Trial Enrollment. Life Science Leader.
3 Tufts Center for the Study of Drug Development (2008). Growing protocol design complexity stresses investigators, volunteers.
Impact Report Vol.10, No.1, Jan/Feb.
4 Beasley, D. (2006). Recruiting special patient populations. Applied Clinical Trials, cited in Hennink-Kaminski H.J. (2014). Join the
Conquest: Developing a Campaign to Increase Participation in Clinical Research in North Carolina. Science Communication. Retrieved
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5 Tufts Center for the Study of Drug Development (2011).
Nearly 60% of all protocols require amendments; one-third are avoidable. Impact Report Vol. 13, No.5, Sep/Oct 2011,
7 Cutting Edge Information (2011). Clinical Operations: Benchmarking Per-Patient Costs, Staffing and Adaptive Design.
8 Wicks, P., Vaughan, T., & Heywood, J. (2014). Subjects no more: what happens when trial participants realize they hold the power?
British Medical Journal, p.348.
9 ibid.
10 Scott, C. (2013). Evolution Summit 2013: Colin Scott Interview. Retrieved March 18,2014 from http://www.marcusevans-life-
sciences.com/index.php/2013/04/10/evolution-summit-2013-colin-scott-interview/
11 King, R. (2009, March). Embracing electronic PRO. Applied Clinical Trials.
12 Wright, R. (2014, Feb). Lilly’s Approach To The Clinical Trial Paradox, Clinical Leader.
13 Zonca, K. (2012, Nov 5). Presentation: Improving Patient Adherence in Clinical Trials. Track 3.6 Building Bridges to Patient-
centered Technology. C3i, Inc.
14 Shore, E. (2013). Defining Disruptive Innovation in Clinical Trials. Clayton Christensen Institute. Retrieved March 15,2014 from
http://www.christenseninstitute.org/defining-disruptive-innovation-in-clinical-trials/
15 Tufts Center for the Study of Drug Development (2014). Drug Developers Circumspect about Using Social Media in Clinical
Research. Impact Report Volume 16 Number 2, March/April 2014. Retrieved March 18,2014 from
http://csdd.tufts.edu/news/complete_story/pr_ir_mar_apr_2014
16 Lipset, C. quoted in Tyer, D. (2012, Jun 21). Pfizer: we won’t abandon social media in trials because virtual study failed. PMLiVE.
Retrieved March 18,2014 from
http://www.pmlive.com/blogs/digital_intelligence/archive/2012/jun_2012/pfizer_wont_abandon_social_media_trials_virtual_study
_failed_408636
17 Blue Chip Patient Recruitment (2011). Patient Recruitment and the E-patient: A Survey Analysis. Blue Chip Marketing Worldwide.
Retrieved March 18,2014 from http://questionsdesante.hautetfort.com/files/BlueChip_SocialMedia_5-2011.pdf
18 Empson, R. (2014, Feb 12). MyHealthTeams Lands $3.3M To Bring Mobile-Friendly Social Networks To Those Living With Chronic
Health Conditions. Tech Crunch. Retrieved March 15,2014 from http://techcrunch.com/2014/02/12/myhealthteams-lands-3-3m-to-
bring-mobile-friendly-social-networks-to-those-living-with-chronic-health-conditions/
19 Bookbinder, M. (2014, April 11). The Rise of the Social Patient: How Connected Patients are Changing Clinical Trials. Clinical
Informatics News. Retrieved March 15,2014 from http://www.clinicalinformaticsnews.com/eCliniqua_article.aspx?id=137286
20 Arnstein, S. R. (1969). A ladder of citizen participation. Journal of the American Institute of planners, 35(4), 216-224.
Join Patient-Centered Clinical Trials 2014, September 4-5 in Boston
Discuss patient centricity in-person with clinical trial leaders and innovators like Joe Kim (Shire),
Tom Krohn (Eli Lilly), Andreas Koester (Janssen), Ken Getz (Tufts), Christine Pierre
(SCRS), David Vulcano (HCA), David Leventhal (Pfizer), Colin Scott (Novartis), Joris Van
Damme (Novartis), Jeremy Gilbert (patientslikeme), Joel Beetch (Celgene), Jeri Burtchell…
www.eyeforpharma.com/clinical
References
27. Join major drug sponsors, research leaders and stakeholders to discuss patient-centered drug development
www.patientclinicaltrials.com
Based on material of leading patient advocacy groups, mainly Clinical Trial Transformation Initiative & Parkinson Disease Foundation
