Ebook: How to Thrive in Today's Patient Recruitment Landscape

Patient
Recruitment
& Retention101:
How to Thrive in
Today’s Recruitment &
Retention Landscape

Part 1: The Recruitment & Retention
Landscape
1. Metrics – Where are we today?………………
2. Protocol Design……………………………………
Part 2: Recruitment Strategies
3. 3 Recruitment Strategies for Trials Today…
Part 3: Retention Planning
4. Keys to Retention Planning……………………
Part 4: Key Takeaways for Sponsors &
CROs
5. Key Takeaways…………………………………….
About this E-book:
With the globalization of clinical
trials rapidly expanding, the
industry’s practices are shifting.
Despite the many tools and
techniques available, patient
recruitment around the globe
continues to cause expensive
delays in the majority of clinical
trials.
In this e-book, we examine the
patient recruitment landscape
today and outline what you can
do to improve your success
with recruitment and retention.
// Page 2
4
8
12
20
28
PATIENT RECRUITMENT AND RETENTION 101
Imperialcrs.com

Part 1:
The Recruitment & Retention Landscape

Since 1991, countless editorials have attempted to describe
how poor recruitment can hamper clinical research.
Problems with patient recruitment have proven to be among
the top reasons for the failure of clinical trials. However,
there have not been any credible comprehensive overviews
of the topic.
Every other link in the clinical trials chain has been
described using standard monographs, including planning,
design, conduct, analysis, interpretation, and publication –
every link except, patient recruitment.
Despite the incomplete picture, it is evident that the current
recruitment landscape is one of the industry’s most
significant areas for concern.
Chapter 1:
Metrics – Where Are We Today?
// Page 4
Imperialcrs.com

When you look at the industry’s data, it quickly becomes evident that the patient recruitment
landscape is failing to perform its duty: to educate patients and bring them into studies. As a result,
the majority of recruitment investments fail to pay off.
$2.9 billion was spent in 2009 on patient recruitment. Of that, the majority of the investment was
most likely lost due to unsuccessful execution based on the following statistics:
Where Are the Dollars Going?
// Page 5
Dr. Wolfgang Eglmeier – Problems in Recruitment & Retention, March 23, 2011
Imperialcrs.com

// Page 6
The retention side of the equation is experiencing a similar disappointment. On average, 25% of
patients fail to complete a trial once they’ve registered. Additionally, average attrition rates are trending
at about 30% and increasing.
The implications of these statistics result in hefty expenses. As the recruitment and retention landscape
continues to underperform, these unfruitful investments lead to delayed trials, increased expenses, and
overall frustration.
Each day a drug is delayed to market, sponsors can lose
up to $8 million!
In addition to delays to marketing, with retention levels where they are in the industry, valuable data is
often lost. The cost to replace patient data is extremely high, and can significantly add to your costs.
Additionally, the lack of patient data may yield the study outcomes obsolete as not enough data is
obtained to have statistical importance.
Imperialcrs.com

These unfortunate trends of recruitment and retention have been relatively consistent around the
globe and across different scenarios. Across the board, site success is indicative of unfruitful patient
recruitment investments. Studies show that about half of all patients recruited are recruited by 15-
20% of sites, and 80% are recruited by the top 40-50% of sites.
It is important to note that recruitment strategists are not to blame. These frightful statistics are not a
result of poor planning, but statistical laws based on the results of modeling. Historically, the clinical
research industry has modeled clinical trials in silos instead of using more appropriate, cross-functional
teams. For example, protocol design and development typically is only looked at from a “pure”
scientific perspective. The challenge this presents is the practicality of successfully operationalizing the
protocol as designed at the site level and, ultimately, at the patient level.
// Page 7
Half of all patients recruited
are recruited by 15-20% of
sites.”
Imperialcrs.com

Protocol design determines the accessibility of the target population. Oftentimes,
sponsors fail to consider recruitment challenges during the protocol design and
development phase. By considering potential enrollment obstacles, the sponsor can help
keep recruitment on target. As a result, this limits the need for protocol amendments
and/or addition of more sites down the road.
With recent advances in technologies and science, it is only natural that the nature of the
industry becomes more complex. The patient recruitment landscape is a rapidly evolving
creature.
It is vital that your team works to develop a model that allows for flexibility
over the course of the trial.
Thankfully, we have laid out four areas to consider during protocol design that will
prepare you for recruitment challenges, and provide you with the flexibility necessary to
navigate today’s market.
CHAPTER 2:
Protocol Design
// Page 8
Imperialcrs.com

1. FDA requirements to advance science
 Longer study participation periods
 Increase in the number of required
procedures
 More study visits before and during the trial
 Increase in targeted patients
2. Availability of patient population: This needs to
be strategically and realistically evaluated at the
start of protocol design.
 Does the target population exist as defined
by the study criteria?
 What are the referral patterns?
 How do individuals become educated about
a clinical trial opportunity?
// Page 9
Consider at Protocol Design:
3. Costly Solutions: What options will you have
lined up?
 Additional sites – an additional site will cost,
on average, $20-$30K in the United States.
 Protocol amendments – these will cost, on
average, $1M.
4. Protocol Support: There is no guarantee that
these solutions will be effective without the
proper support in place.
 Evaluate the site’s understanding of the study
design and program offered to support
enrollment. Are they bought-in to the
resources made available?
 Evaluate the site structure and experience.
Do they have established referral and patient
identification pathways?
Imperialcrs.com

Case Study
Situation
DAC Patient Recruitment Services (www.dacprs.com) recently embarked on a recruitment journey for a
clinical trial on Lysosomal Acid Lipase (LAL) Deficiency. At the time we joined, the study was working
with four sites, eight patients, and a 3-month enrollment duration.
Challenges
Throughout the industry, there has been a lack of specific LAL education among physicians. LAL is an
under-recognized disease among physicians and, therefore, under-diagnosed. As a result, the study
was dealing with an extremely limited patient population due to the rarity of the disease (1 in 100,000
in the United States). It was difficult to identify and evaluate the protocol design to determine if the
target population was available and how to reach them.
Solution
As this patient population is predominantly pediatric patients, the target audience was the parent. Most
parents are extreme activists for their children. Therefore, they reach out and participate in patient
advocacy and support groups for LAL or Wolman disease. This coupled with the disease being under-
recognized among physicians led to the development of an educational program targeting advocacy
and support groups as well as potential referring physicians. Both groups were targeted equally to build
overall awareness of the disease and the symptoms to consider.
// Page 10PATIENT RECRUITMENT AND RETENTION 101
Imperialcrs.com

Part 2:
Recruitment Strategies

CHAPTER 3:
3 Recruitment Solutions for Trials Today
Over the years of modernized clinical trials, a number of basic techniques have repeatedly
led to successful patient recruitment. Techniques such as educational materials and
patient identification toolkits have proved to be effective. These basic information sources
are important, and should not be overlooked when developing a recruitment strategy.
However, in recent years, the realm of ‘successful patient recruitment strategies’ has
vastly expanded. New technology allows for recruitment professionals to be more creative
and targeted in their approach to seek out more qualified individuals. The industry now
has access to a wide range of techniques that are quickly proving to be indispensable, and
are becoming standard practices. Here are three successful solutions for patient
recruitment in today’s arena.
// Page 12
Imperialcrs.com

1. Social Media
Considered the modern day “word-of-mouth,” social media presents a unique opportunity to spread the
word in a quick and cost-effective manner. Platforms such as Facebook, YouTube and online social
communities present great opportunities for identifying individuals who are seeking options or for
others to share their experiences. Social media also allows for geo-targeted campaigns to focus your
efforts only on logistically sound targets.
With social media comes a number of legal questions as the industry works to define the regulations
around this medium. Always be sure to speak with your recruitment provider to understand the
boundaries of this medium.
// Page 13
3 Recruitment Solutions
for Today’s Trials
Take advantage of the modern day “word-
of-mouth” to maximize trial recruitment.
Imperialcrs.com

2. Study Website
Study websites are quickly becoming a preferred component of clinical trials across the globe. These
websites present an unmatched opportunity to provide relevant information to a highly engaged
population. Individuals will come to your study website for the sole purpose of learning about your trial for
themselves or a loved one. This population is extremely engaged and motivated. When designing your
website, be sure to capitalize on this engagement using various calls-to-action. This will move the
individual further down the pipeline. For tips, check out our recent blog post on the secret to a successful
study website.
A study website allows you to provide more information than most other recruitment options.
Websites provide more landscape for text, and more options for engagement. They also allow you to link
to other credible or supporting organizations’ websites. Oftentimes study websites will include an online
pre-screener. This allows for easy access and an immediate response for the participant.
If a study website is something you’re interested in, we strongly recommend using pay-per-click
advertising and search-engine optimization (SEO) to market your website and drive traffic to it. Typically,
potential patients are not going to enter your website URL to directly access the site – you need to real
them in.
Imperialcrs.com

Study Website Implementation Considerations:
Study websites are no light investment. Before pursuing a website there a certain items to consider.
• Length of enrollment and regulatory approval timelines. Websites typically take 8-10 weeks to develop.
Regulatory approval can take from 2 days up to 3 months depending on the use of central IRBs, local
IRBs and/or ethics committees. Therefore, it could take a minimum of 3 months to launch a website. If
your study has a 6 month enrollment timeline and involves a large percentage of sites that use local
IRBs and/or involves multiple countries, you’ll want to evaluate the impact of instituting a website.
• Countries involved. Most recruitment strategies are accepted from a regulatory perspective worldwide,
but cultural acceptance varies. Central and Western Europe are typically more receptive to study
websites, while Eastern Europe and the Baltic Region are not as receptive. This is an important
consideration when evaluating the use of a study website. Culturally, if the use of a website is not an
accepted practice within a particular country, then one would not invest the time or money in
developing and seeking approval of this strategy.
*Recently, DAC signed an exclusive partnership with Remedy Health Media. This 12-month partnership
provides our clients with unmatched access to the most engaged online communities. To learn more about
the opportunities available to you, you can read the press release or listen to our podcast interview with
Dennis Upah, Executive Vice President at Remedy.
Imperialcrs.com

3. Pharmacy Outreach
This is a strategy that has grown in popularity over the last couple of years due to the ability of being
highly “prescriptive” in identifying potential study participants as it correlates to inclusion and exclusion
study criteria as well as targeted geographies. Pharmacy outreach is one of the most targeted direct-to-
patient outreach approaches you can consider in supporting your recruitment program, which will
positively impact your overall retention.
Due to the targeted nature of this strategy, response and referral rates typically are 28% and 13% higher
than traditional outreach (i.e., direct mail campaigns), respectively.
Pharmacy outreach is one
of the most targeted, direct-
to-patient approaches.”
Imperialcrs.com

CHAPTER 4:
Keys to Retention Planning
While a tailored patient recruitment strategy is necessary to start a trial off on the right
track, it is also vital to be mindful of your plan to keep these patients engaged once
recruitment efforts take off. Retention starts when the first patient is enrolled into the
study. Often, sponsors wait too long to consider retention, and find themselves trying to
make up for lost time. As a result, attrition rates and costs skyrocket.
// Page 18
Hopefully you understand that retention planning must
be part of the initial study design to avoid costs and
delays down the road. In this chapter, we will tell
you how to plan for retention and define
various keys to success.
Imperialcrs.com

// Page 19
Remember that patient retention starts with the first patient enrolled! The following guidelines will help
you set timelines to get your retention plan off to a great start.
• Know your IRB/EC and each country’s guidelines. From here, you can backtrack to determine the
starting point for planning.
• Establish a line item for retention in each study budget. Consider allocating 5% of site per patient
grants for retention.
• 90% of sites have no formal plan/funds to address retention – don’t get caught in this trap! It
is also important to increase your allocation based on the therapeutic indication or length of
the study.
• Provide a site training and support continuum. Successful retention programs start with site buy-in.
Be sure to provide ample time and resources to educate and engage your sites. Part of this training
is to ensure that sites understand the patients’ motivators and deterrents.
• Keep the “Appreciation for Participation” top-of-mind with every study participant and caregiver.
When to Plan
Imperialcrs.com

// Page 20
Developing a program that offers the level of information an individual seeks, as well as an ongoing
dialogue that meets their expectations if they choose to participate in a trial is two-thirds of the trial. It
is essential to consider the expectations of clinical trial patients when developing a retention plan. Here
are some patient expectations to consider:
2/3 of the Challenge
• Explanation of potential side effects
It is important to the patient to feel educated
and aware of the situation they are getting
into.
• Access to the PI at every visit
• Reimbursement of travel/parking expenses
Transportation assistance packages have
shown a reduction of attrition by 45+% and
LTFU less than 7%.
• Opportunities to meet other participants
• A supportive website just for study
participants
A mobile app has shown to reduce attrition by
45+% and LTFU less than 7%.
• A mechanism to tell friends about the study
• Progress reports and lab results
Patients expect to know how they are
responding to the study. They will want to feel
involved in the success of the study.
Imperialcrs.com

6 Keys to Retention Success
// Page 21
There is a large body of literature and study participant surveys that provide detailed information and
can help define a successful retention program. The literature supports that trial participants want to
be informed and receive ongoing information and education about their disease and diagnosis. They
desire this information to make a decision to participate in clinical trials, and the continued desire for
ongoing information is needed to create that “sense” of being part of something bigger. Their
contribution does count and makes a significant difference in the lives of others through the
advancement of science.
In layman’s terms, think about trial participants as consumers. And, think about all the information we
expect to have at our fingertips when it comes to purchasing a service or product. Trial participants are
one and the same. The following six elements provide the right formula for a successful retention
program:
1. Understand, Educate, and Inform the Patient. Take the time needed to talk to the patient
and their caregiver about the requirements of the trial and what they are committing to. Ensure
the sites have the right tools necessary to educate the patients and their caregivers about the
study. Tools should include those that remain at the site for reoccurring use as well as take-home
materials. Successful retention greatly depends on the relationships that the research staff forges
with the patients. The sooner trust is established, the more likely patients will feel a sense of
commitment to the trial.
Imperialcrs.com

6 Keys to Retention Success
// Page 22
2. Appeal to the Patient’s Needs. Surveys show that patients want to receive ongoing education about
their disease state. This can be established through the distribution of patient newsletters, brochures,
etc.
3. Motivate the Patient to Participate. There are a number of reasons people choose to participant in
clinical trials. Understanding these motivations can help enhance study engagement and compliance.
For example, one motivator is receiving care from a specialist who, otherwise, may not be available. In
this instance, the research staff wants to ensure that the PI spends quality time with his/her patients.
4. Offer Unprecedented Care and Attention. Ensure enough time is allocated for each patient visit
with all research staff needed. Provide contact information for patients to connect with study staff
throughout the trial period. Responses to all calls should happen within 24 hours.
5. Show Explicit Appreciation. This can be accomplished by sending motivational text messages or
holiday, birthday, and thank-you cards. Just a simple note can express appreciation for their continued
commitment and participation in the study.
6. Demonstrate the Value of Their Contribution. Maintain ongoing communication with the trial
participants and follow through with what you tell them you will do.
Imperialcrs.com

It was imperative that a proactive retention campaign be implemented to offset this
projected attrition. DAC provided study support materials to assist in fostering and maintaining a
long-term relationship with the patient, as well as branded patient support items to keep the study top-
of-mind. The receipt of educational and support items throughout the trial provided a sense of
“belonging” to the study participants. They felt they were part of something important and not just
volunteers. This helped them feel invested in the overall program.
As a direct result, attrition rates trended no higher than 10% throughout the trial.
// Page 23
Case Study: Alzheimer’s Retention Program
DAC Patient Recruitment Services
recently worked on a mild-to-
moderate Alzheimer’s retention
program over a 12-month time
period. We worked with 70 sites
and 930 patients across nine
countries. Due to the known
short-term side effects of the
compound, the sponsor projected
a 35% attrition rate.
Imperialcrs.com

As society embraces technological advances in communication, we have seen an upsurge in the number of
study participants and/or caregivers who have and use mobile technology. Worldwide, there are 4.55 billion
mobile users and 1.75 billion smartphone users. And it’s predicted that smartphone subscriptions will
increase to 5.6 billion users by 2019, covering 90% of the world’s population. Maintaining retention rates in
a trial is just if not more important than hitting the enrollment goals. Without data to support statistical
analysis, the trial itself becomes a mute point.
The use of text messages to maintain patient engagement and compliance while reducing administrative
burden at the site level is taking off in full force. Ninety-eight percent of all text messages are read within
15 minutes of receipt. You know that the intended messages reach patients. Even with the high read rate,
there are a few points of consideration when determining if text messaging is the right strategy for your
retention program.
Points to Consider:
• Therapeutic Area
Does the disease indication lend itself to acceptance of text messages for visit reminders? For example,
for an oncology study you may consider using a more traditional, personal approach with visit reminder
calls versus an automated text messaging system.
Text Messaging to Improve Retention
Imperialcrs.com

• Age of Participant
As with the disease indication, you’ll want to take into account the age of the participant and if
there is caregiver involvement. For example, it may not be prudent to send text messages to an
Alzheimer’s patient. However, it may be perfectly plausible to send them to the caregiver, who is
mostly likely familiar with texting.
• Length of Enrollment Period; Number of visits
Text messaging is more cost effective for studies with a higher number of visits. Much like cost
efficiencies achieved when you print higher quantities versus smaller quantities, the higher the
number of visits required in a study the greater the cost savings.
Test messaging
is more cost
effective for
studies with a
higher number
of visits.”
• Mobile Technology Penetration in
Participating Countries
While the adaptation of mobile
technology is strong across more
prominent countries, there are still
some regions with low penetration
rates. It’s important to understand
what these penetration rates look
like, as it will dictate the overall
adoption of this technology solution
among the participating research
centers and their patients.
Imperialcrs.com

Part 4:
Key Takeaways for Sponsors and CROs

Here are four key action items to take to your next recruitment discussion. Above all
else, remember that each patient is valuable and should be treated as such.
CHAPTER 5:
Key Takeaways
// Page 27
1. Protocol Design
Patient recruitment and retention starts at protocol design. Be sure to engage clinical operations as
well as your partners and recruitment specialists. A challenge for you to consider would be to
engage a potential patient as part of your protocol review team.
2. Evaluate the Patient Population
Determine your available patients based on protocol criteria. It is a highly competitive landscape
thanks to competing studies and resources. Only once you have a clear picture of who you will be
targeting, can you begin to plan for recruitment and retention.
3. Proactive vs. Retroactive Planning
Proactive planning can save your trial millions in future expenses by limiting the addition of new
sites, protocol amendments, and replaced patients, and costly delays.
4. Establish a Line Item in Each Study Budget
The recruitment cost per patient can vary from $1,500 to $10,000+, based on indication, length of
study, and study requirements. Consider allocating at least 5% of site per patient grants for
retention.
Imperialcrs.com

Melynda Geurts
Vice President of Operations
DAC Patient Recruitment Services
Melynda is a 22-year DAC veteran with expertise that spans protocol planning, recruitment and
retention, global regulations, emerging markets, and more. She was instrumental in DAC’s rise from a
niche SMO to a global recruitment and retention leader, and is a driving force in the company’s
approach to project operations, site management, contract negotiations, and business development.
Melynda is a 2008 inductee into the PharmaVoice 100 Most Inspiring People in the Life-Sciences.
// Page 28
About the Author
Imperialcrs.com

If you’re interested in speaking with our recruitment
and retention specialists, contact us today!
recruit@dacprs.com
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