Clinical trials face increasing challenges like longer timelines and higher costs due to outdated regulations from the 1970s. Modernizing the clinical trials process could help address these issues through approaches like increased data sharing and reuse of electronic health records. The EHR4CR project aims to develop new business models for pharmaceutical companies to collaborate and reuse hospital patient data from electronic health records to help accelerate patient recruitment and reduce trial timelines. This emphasizes moving towards more personalized, data-driven trials with the right targeted patients through closer collaboration between pharmaceutical companies and healthcare organizations.
Strategies for Considerations Requirement Sample Size in Different Clinical T...IJMREMJournal
-------------------------------------------------------ABSTRACT ---------------------------------------------------
Usually the main problem face any investigation it how to determent a sample size, however, some
considerations required in sample size to conduct the efficacy and make realistic well-researched before began
study. This study aimed to determine the maximum possible sample size at different phases of clinical trials and
attempt to achieve the best accuracy of the results. To achieve that the maximum sample size in different phases
we found that the maximum sample size of phase I was (75) relies on largest response rate 20% and the minimal
clinically important difference (MCID) 15%, and because the participants are healthy often that means 15%
enough to show positive results of the transition to the second phase. for the phase II clinical trials; the
maximum sample size was (388) depend on the error 5% and largest response rate 50% when the response rate
should not be less than 20% according to the design used in this phase. Depend on the endpoint and hazard
ratio in phase III clinical trials when the probability of survival of the treatment group equal to median of the
probability of survival 50% we found that the maximum sample size (4796). For the phase IV the maximum
sample size in different phases of clinical trials does not affect whatever the large of the population size and
remains constant as large as possible size.
Patient Perspectives on Lay Trial Results SummariesCISCRP Page
This presentation will be presented by Behtash Bahador, CISCRP's Senior Manager of Quality and Compliance at the Disclosure & Transparency for Clinical Data Summit on August 13-14, 2018. To learn more at CISCRP's Lay Summaries visit www.ciscrp.org or contact Jay Matthews at jmatthews@ciscrp.org.
Strategies for Considerations Requirement Sample Size in Different Clinical T...IJMREMJournal
-------------------------------------------------------ABSTRACT ---------------------------------------------------
Usually the main problem face any investigation it how to determent a sample size, however, some
considerations required in sample size to conduct the efficacy and make realistic well-researched before began
study. This study aimed to determine the maximum possible sample size at different phases of clinical trials and
attempt to achieve the best accuracy of the results. To achieve that the maximum sample size in different phases
we found that the maximum sample size of phase I was (75) relies on largest response rate 20% and the minimal
clinically important difference (MCID) 15%, and because the participants are healthy often that means 15%
enough to show positive results of the transition to the second phase. for the phase II clinical trials; the
maximum sample size was (388) depend on the error 5% and largest response rate 50% when the response rate
should not be less than 20% according to the design used in this phase. Depend on the endpoint and hazard
ratio in phase III clinical trials when the probability of survival of the treatment group equal to median of the
probability of survival 50% we found that the maximum sample size (4796). For the phase IV the maximum
sample size in different phases of clinical trials does not affect whatever the large of the population size and
remains constant as large as possible size.
Patient Perspectives on Lay Trial Results SummariesCISCRP Page
This presentation will be presented by Behtash Bahador, CISCRP's Senior Manager of Quality and Compliance at the Disclosure & Transparency for Clinical Data Summit on August 13-14, 2018. To learn more at CISCRP's Lay Summaries visit www.ciscrp.org or contact Jay Matthews at jmatthews@ciscrp.org.
Feasibility Solutions to Clinical Trial Nightmaresjbarag
Slow patient recruitment and poor retention cause recurrent nightmares and perpetual problems often resulting in missing recruitment milestones. The cost of these delays represents hundreds of thousands of dollars for drug and device developers. By recognizing this issue, early detailed feasibility can provide planning and contingency solutions that are focused on reducing the impact of delayed recruitment. Furthermore understanding what motivates investigators and patients to actively participate in clinical studies and how patient recruitment strategies and materials can support all stakeholders to complete studies on time are critical aspects of clinical study delivery planning.
During this presentation, an experienced Premier Research feasibility and patient recruitment specialist, reviewed feasibility approaches to address protocol evaluation as well as addressed influences on country selection, site distribution and patient recruitment strategies to provide for more effective clinical trial planning and conduct.
For more information, go to http://www.premier-research.com.
POINT-of-IMPACT testing. A European perspective - Bert NiestersWAidid
At SoGat meeting 2019 Bert Niesters - Professor in Molecular Diagnostic in Clinical Virology, Medical Molecular Microbiologist at University Medical Center Groningen, Department of Medical Microbiology, Division of Clinical Viroloy, The Netherlands - has talked about the developing trends in molecular diagnostics and the impact on the Laboratory.
To learn more, please visit www.waidid.org!
In the current phase (controversy-free period) traditional risk-aversion to new technology is muted. The ‘pendulum shifted’ towards commercialization about a decade ago
The need for, and adequacy of, risk-assessment and risk-management in commercial setting is highly variable.
Nanoscience and nanotechnology publications often tout ‘transdisciplinary’; evidence from social science perspective suggests much of the research is ‘uni-disciplinary’.
Tactic knowledge plays a significant role in science to technology transfer; ability to do both within a group or organization is advantageous. A transdisciplinary approach to regulatory policy development would be important for efficient standardization of frameworks, concepts, tools and vocabulary.
Protocol Design & Development: What You Need to Know to Ensure a Successful S...Brook White, PMP
Solid protocol design is critical to clinical development. No matter how well executed a clinical study is, if the underlying design is flawed, it wasn’t worth doing. In this presentation, Dr. David Shoemaker, SVP R&D, and Dr. Karen Kesler, AVP Operations, will walk through the process of developing a protocol, explain the major considerations, and point out common mistakes and challenges.
- Discover new methods for managing clinical next-gen data with insights from Pfizer, Boston Children’s Hospital and AstraZeneca
- Uncover and critique the latest technologies out there for you to use in clinical trials. Mayo Clinic, Merck and Harvard Medical School let you into their trade secrets
- Hear the genomics strategies that Roche, Millennium and Regeneron are using for discovery and validation of clinically actionable biomarkers
-Bristol-Myers Squibb, Takeda and Partners Healthcare the role that NGS can play when implementing an effective strategy in the lab to speed up CDx development
- Learn how to integrate molecular details into medical decision making, with fresh data from Washington University School of Medicine and Genzyme
The Indian Dental Academy is the Leader in continuing dental education , training dentists in all aspects of dentistry and
offering a wide range of dental certified courses in different formats.for more details please visit
www.indiandentalacademy.com
Evidence based orthodontics /certified fixed orthodontic courses by Indian d...Indian dental academy
The Indian Dental Academy is the Leader in continuing dental education , training dentists in all aspects of dentistry and offering a wide range of dental certified courses in different formats.
Generic non-biological complex drugs DIA CMC Workshop 2017Ajaz Hussain
#DIACMC17
Assigned title for the talk by the organizers:“The need of conducting clinical study for assuring safety and efficacy, as well as a lack of immunogenicity for generic NBCDs”
SUMMARY
Integrated analytical, product and process development to reduce uncertainty in ‘pharmaceutical equivalence’ is the foundation on which confidence in generic drugs rests
Need to leverage the context: RLD “Prescribe-ability” and lot-lot “Switchability” is acceptable
The “sameness” mindset (as opposed to an “equivalence” mindset) poses challenges to evidence ‘synthesis” (not “piece meal” check the box ) in ANDA submissions
Integrated evidence must a priori account for posed/anticipated “legal challenges” intrinsic to the US system
Clinical assessment of Therapeutic Equivalence of generic product intended (i.e., designed) to be equivalent to RLD should only be needed in rare circumstances
When there is a need to provide assurance to non-scientists stakeholders
Currently the FDA’s GADUFA Research and efforts by many in the sector are predominantly focused on developing a “test of bioequivalence”
For most complex products such a test, in and of itself, may be insufficient to ensure therapeutic equivalence over generic product life-cycle
Feasibility Solutions to Clinical Trial Nightmaresjbarag
Slow patient recruitment and poor retention cause recurrent nightmares and perpetual problems often resulting in missing recruitment milestones. The cost of these delays represents hundreds of thousands of dollars for drug and device developers. By recognizing this issue, early detailed feasibility can provide planning and contingency solutions that are focused on reducing the impact of delayed recruitment. Furthermore understanding what motivates investigators and patients to actively participate in clinical studies and how patient recruitment strategies and materials can support all stakeholders to complete studies on time are critical aspects of clinical study delivery planning.
During this presentation, an experienced Premier Research feasibility and patient recruitment specialist, reviewed feasibility approaches to address protocol evaluation as well as addressed influences on country selection, site distribution and patient recruitment strategies to provide for more effective clinical trial planning and conduct.
For more information, go to http://www.premier-research.com.
POINT-of-IMPACT testing. A European perspective - Bert NiestersWAidid
At SoGat meeting 2019 Bert Niesters - Professor in Molecular Diagnostic in Clinical Virology, Medical Molecular Microbiologist at University Medical Center Groningen, Department of Medical Microbiology, Division of Clinical Viroloy, The Netherlands - has talked about the developing trends in molecular diagnostics and the impact on the Laboratory.
To learn more, please visit www.waidid.org!
In the current phase (controversy-free period) traditional risk-aversion to new technology is muted. The ‘pendulum shifted’ towards commercialization about a decade ago
The need for, and adequacy of, risk-assessment and risk-management in commercial setting is highly variable.
Nanoscience and nanotechnology publications often tout ‘transdisciplinary’; evidence from social science perspective suggests much of the research is ‘uni-disciplinary’.
Tactic knowledge plays a significant role in science to technology transfer; ability to do both within a group or organization is advantageous. A transdisciplinary approach to regulatory policy development would be important for efficient standardization of frameworks, concepts, tools and vocabulary.
Protocol Design & Development: What You Need to Know to Ensure a Successful S...Brook White, PMP
Solid protocol design is critical to clinical development. No matter how well executed a clinical study is, if the underlying design is flawed, it wasn’t worth doing. In this presentation, Dr. David Shoemaker, SVP R&D, and Dr. Karen Kesler, AVP Operations, will walk through the process of developing a protocol, explain the major considerations, and point out common mistakes and challenges.
- Discover new methods for managing clinical next-gen data with insights from Pfizer, Boston Children’s Hospital and AstraZeneca
- Uncover and critique the latest technologies out there for you to use in clinical trials. Mayo Clinic, Merck and Harvard Medical School let you into their trade secrets
- Hear the genomics strategies that Roche, Millennium and Regeneron are using for discovery and validation of clinically actionable biomarkers
-Bristol-Myers Squibb, Takeda and Partners Healthcare the role that NGS can play when implementing an effective strategy in the lab to speed up CDx development
- Learn how to integrate molecular details into medical decision making, with fresh data from Washington University School of Medicine and Genzyme
The Indian Dental Academy is the Leader in continuing dental education , training dentists in all aspects of dentistry and
offering a wide range of dental certified courses in different formats.for more details please visit
www.indiandentalacademy.com
Evidence based orthodontics /certified fixed orthodontic courses by Indian d...Indian dental academy
The Indian Dental Academy is the Leader in continuing dental education , training dentists in all aspects of dentistry and offering a wide range of dental certified courses in different formats.
Generic non-biological complex drugs DIA CMC Workshop 2017Ajaz Hussain
#DIACMC17
Assigned title for the talk by the organizers:“The need of conducting clinical study for assuring safety and efficacy, as well as a lack of immunogenicity for generic NBCDs”
SUMMARY
Integrated analytical, product and process development to reduce uncertainty in ‘pharmaceutical equivalence’ is the foundation on which confidence in generic drugs rests
Need to leverage the context: RLD “Prescribe-ability” and lot-lot “Switchability” is acceptable
The “sameness” mindset (as opposed to an “equivalence” mindset) poses challenges to evidence ‘synthesis” (not “piece meal” check the box ) in ANDA submissions
Integrated evidence must a priori account for posed/anticipated “legal challenges” intrinsic to the US system
Clinical assessment of Therapeutic Equivalence of generic product intended (i.e., designed) to be equivalent to RLD should only be needed in rare circumstances
When there is a need to provide assurance to non-scientists stakeholders
Currently the FDA’s GADUFA Research and efforts by many in the sector are predominantly focused on developing a “test of bioequivalence”
For most complex products such a test, in and of itself, may be insufficient to ensure therapeutic equivalence over generic product life-cycle
Christians often feel intimidated when talking to others about creation--not because they doubt creation but because most of academia doubts it. Feel that way no longer! The chapter discusses, in simple language, the logic behind creation and the irrational thought those who doubt creatoin must accept live with.
Global Medical Cures™ | Paving way for Personalized Medicine (2013) Global Medical Cures™
Global Medical Cures™ | Paving way for Personalized Medicine (2013)
DISCLAIMER-
Global Medical Cures™ does not offer any medical advice, diagnosis, treatment or recommendations. Only your healthcare provider/physician can offer you information and recommendations for you to decide about your healthcare choices.
Novel Approaches to Clinical Trial Design and Implementationijtsrd
Companies are working hard to adopt and execute efficient and innovative approaches to accelerate drug releases, giving the clinical research sector a big makeover. The difficulty of powering and recruiting participants into a study in a small and frequently heterogeneous population, the dearth of natural history data informing crucial design elements, and the ethical and recruitment difficulties associated with assigning patients to a placebo arm are all obstacles to the clinical development of new therapies. The goal of this article is to present innovative clinical trial design methods, including adaptive designs, Bayesian techniques, and master protocol designs basket and umbrella designs . It is intended that this review will increase knowledge of these methods and promote their application in research. R. Saraswathi | Rabin Kumar Parida "Novel Approaches to Clinical Trial Design and Implementation" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-7 | Issue-2 , April 2023, URL: https://www.ijtsrd.com.com/papers/ijtsrd56252.pdf Paper URL: https://www.ijtsrd.com.com/other-scientific-research-area/other/56252/novel-approaches-to-clinical-trial-design-and-implementation/r-saraswathi
Oncology Clinical Development Challenges and Opportunities in the Phase 1 Set...Roberto Lara
This article provides a brief overview of targeted cancer therapy and discusses certain challenges to their development as they relate to the Phase I clinical setting. A unique breakthrough strategy is also presented that supports the efforts of both sponsors and clinicians.
Commercial considerations in early drug developmentSunil Ramkali
It is important in the drug development process that marketers and researchers collaborate early to ensure that products being developed are truly innovative and deliver brand value to the different end users in a way that the product and the subsequent brand messaging is relevant, compelling and differentiating compared to the competition. T
In the market place that is heavily cost constraint, innovation is no longer about a unique mode of action or a new formulation, but more about the incremental brand value offered by new pharmaceutical products over existing treatments (standard of care) and how much healthcare systems are prepared to pay for these incremental benefits. My lecture at the Department of Innovation, Lund University, Sweden explored the importance of R&D functions getter closer to external stakeholders to really understand their needs, how they define brand value and the importance of considering this early in the drug development process.
GSK’S Andrew Witty: Addressing Neglected Tropical Diseases and global health ...Nejmeddine Jemaa
Every day, Non Governmental Organization NGOs is confronted with the lack of access to adequate or affordable medical tools in the field. They face two major challenges the high cost of existing medicines on the one hand, and the absence of appropriate or effective treatments for many of the diseases affecting our patients on the other, we are talking about Neglected Tropical Disease NTD in the Least developed Countries LDCs.
Andrew Witty, Chief Executive Officer of Glaxo Smith Klein (GSK) delivered a speech at the Harvard Business School in Boston on February 2009 entitled “Big pharma a catalyst for Change” focused on two issues: a) promoting innovation to prevent or treat NTDs in the world’s Least Developed Countries by creating a “pharmaceutical patent pool”; b) improving the access to medicine in the poorer countries by lowering the prices of GSK’s medicines.
In deed, we are assisting a radical change in pharma Business model, we are moving from conflict to collaboration through the Medicines Patent Pool in the hope that it speed up access to newer medicines, and boost initiatives that make use of alternative financing mechanisms in order to develop new, more appropriate treatments that respond to medical needs.
On the other hand the pricing strategy dilemma facing the generic manufacturers and the non inclusion of HIV which is a major neglected disease in LDCs in the patent pool may compromise the success of such business model.
In order to deal with that two issues, GSK should include HIV drugs in their patent pool as other manufacturers and NGO are doing, and concerning the pricing strategy they should emphasize on the high quality of the original drug mandatory to eradicate this NTDs and communicate more on the fact that GSK will invest 20% of these drugs profit to improve the infrastructure of these LDCs.
Patient safety has always been the industry’s focus during clinical trials. However, a recent spate of well-publicized patient safety issues have increased public scrutiny and the biotechnology, pharmaceutical and CRO industries' desire to improve study quality, resulting in larger, longer, more expensive trials. In this Q&A, James T. Gourzis, M.D., Ph.D., discusses issues affecting patient safety, including factors that have launched safety to the forefront; what to look for in evaluating CRO excellence; unique oncology considerations and the ramifications of the rare toxicity; optimizing the Data Monitoring Committee; budget decisions that affect patient safety and the evolution/future of FDA requirements.
Similar to Testing times for clinical trials - Perscetives on personalised health care (20)
Testing times for clinical trials - Perscetives on personalised health care
1. Insight > Clinical trials
Testing times for
clinical trials
Clinical trials face more hurdles than ever – not least protracted timelines and soaring costs
But with study design constrained by outdated regulations, rising to these challenges is
proving difficult. Abi Millar talks to the FDA and Mats Sundgren, principal scientist in clinical
development for AstraZeneca, to discover how the clinical trials framework is being modernised.
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2. Insight > Clinical trials
I
n April 2012, the FDA held a public consultation,
‘Modernising the regulation of clinical trials and Mats Sundgren
Mats Sundgren is a principal scientist in global
approaches to good clinical practice’. With its broad medicine development, biometrics and information
range of speakers, drawn from the full spectrum of sciences, AstraZeneca R&D. He has over 26 years’
experience in the pharmaceutical industry.
stakeholders, the hearing provided rich grounds for debate. All
had their own ideas about how the clinical trials framework
could best be overhauled.
One aspect, however, was unequivocal: with current regulations Case study: clinical trial of the future
dating back to the 1970s, there is little case for maintaining the The goal of this trial is to develop a set diagnostic tool and
status quo. Tailored towards a hugely different environment, biomarker for diabetes. This involves a large amount of
data – internal and external.
existing strictures are poorly suited to trials in 2012. While the project is primarily driven by a pharmaceutical
“There have been dramatic changes in the clinical trials company, the R&D stage takes place as a collaborative
enterprise,” says the FDA’s Michelle Bolek. “These include venture with the healthcare industry. During this phase, the
increased size and complexity of trials, rises in the number tool is supported by sophisticated reuse and data mining of
health information, including electronic health records (EHRs).
of trials performed globally, greater use of CROs, participation Its success in the phase I and II trials depends on the
of vulnerable populations, and numerous scientific and outcomes of a finely tuned group of patients, who, in turn,
technological advances.” have been selected through EHRs. These studies are carried
Faced with this cultural sea change, the industry cannot be out using devices and sensors, handled by the patients
themselves, which monitor glucose levels in real time. An
content with minor tweaks. With costs continuing to rise –
interactive patient evaluation, the studies provide far more
average expenditure has tripled over the past 12 years – information than is usually captured in clinical trials.
healthcare systems running trials are creaking under the strain.
Furthermore, outmoded policies make it hard to integrate new
technologies. It is clear that purging the inefficiencies from the will help identify issues that may inform additional
system will amount to all-out reform. harmonisation efforts.”
For now, though, the challenges posed by drug development
Personalised healthcare is the show few signs of abating. As such problems become entrenched,
bodies outside the FDA are urgently seeking solutions of their own.
approach now taken by the industry.
We are no longer trying to produce Narrow the field
drug products that treat the majority For Dr Mats Sundgren of AstraZeneca, the situation requires
radical thinking. Principal scientist in clinical development, he
of the population. is also one of 33 partners of the Innovative Medicines
Initiative’s Electronic Health Records for Clinical Research
This, of course, is not the first time these issues have been (EHR4CR) project, and the coordinator on behalf of
raised. The Critical Path Initiative, aimed at improving clinical AstraZeneca. A four-year undertaking with EU backing, the
trial practice and policy, was introduced as early as 2004. project endorses a full-scale paradigm shift.
Similarly, the Clinical Trials Transformation Initiative (2007) came “The pharma industry has been unable to develop innovative
about in response to sky-high prices and stifled innovation. products for the last two decades,” explains Sundgren. “The
Unfortunately, such initiatives have come under flak for not attrition rate is a big problem, with only 2–5% of projects
being transformational enough. Speaking at the FDA hearing, actually hitting the market. So there’s huge pressure on the
Doug Peddicord from the Association of Clinical Research industry, and that’s reflected in clinical trials.”
Organisations alleged that their “research on research” Sundgren is emphatic that the next few years will see
approach was unlikely to “facilitate any significant change to important changes in the healthcare industry. As older
current practices, let alone transformation of the enterprise”. drugs lose their patents and advances in genomics make
He went on to lay out suggestions for how the FDA might themselves felt, healthcare is moving into an area of
progress. The Clinical Trials Transformation Initiative, he said, personalised medication.
should perform comparator studies that pit old approaches “Personalised healthcare is the approach now taken by the
against new. Their goal should be to demonstrate “actual industry,” he says. “We are no longer trying to produce drug
savings in development time and cost for a given product”. products that treat the majority of the population of the planet.
And patient needs should always be given precedence This means we need to target and understand the right
over the whims of corporations or institutions. Since the patients. To test if our inclusion/exclusion criteria make sense,
hearing took place, the FDA has been busy assessing the we need to have much more external health information and
points that were raised. patient data.”
“We will consider the suggestions received at the April The trend is towards a culture in which each disease-
hearing, as well as our stakeholders’ suggestions for management model is adapted to a patient’s genetic profile.
improving the regulations,” says Bolek. “Input from the public Often described as ‘translating bench science to bedside
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3. Insight > Clinical trials
clinical practice’, this movement into personalised healthcare way,” he says. “This is a very sensitive area in which all
holds great promise for treatment and diagnostics; however, stakeholders must be transparent. We also need to find a
the industry will need to push beyond its limitations before any sustainable and scalable solution. Pharma companies should
significant changes can take place. be able to choose the hospitals that are preferred for a certain
Under the present framework, personalised medicine is drug or patient category, and one of the levers will be platforms
difficult to accommodate in clinical trials, and patient that allow virtual integration of data from different sources.”
recruitment is a case in point. Even with present levels of Looking back several decades, there is an analogous
selectivity, late-stage clinical trials can take up to a year to situation within the banking sector. Faced with their own
locate their subjects. Narrowing down the criteria to certain dilemma – how best to leverage information technology to
genotypes is hardly poised to simplify matters. make trustworthy financial transactions – banks worked
This issue is one of the key dilemmas being addressed by together to create the standardised messaging network SWIFT.
EHR4CR. In essence, the project’s aim is to find ways of While this analogy is imprecise, it usefully illustrates how
reusing existing electronic health records (EHRs) of hospital competitors can join forces.
patients in clinical research. A rich seam of data, previously In these financially beleaguered times, the real question to
untapped by pharma companies, EHRs could greatly accelerate ask is whether pharma companies can afford not to collaborate.
patient recruitment and shrink the development timeline for The EHR4CR project, after all, does not just stand to benefit
new medicines. patient recruitment. It is relevant to protocol feasibility, clinical
“We have identified the top-ranking services that the trial execution and drug surveillance reporting. All these areas
pharmaceutical industry is asking for in order to enhance the will reap rewards from a more data-intensive and
efficiency of clinical trials, and one of these is finding the right multidisciplinary approach.
patients,” says Sundgren. “We are aiming to develop a new “Over the next ten years, the industry will conduct smaller
business model in order to ensure we can reuse electronic but more data-rich trials, with exactly the right patients,” says
health records to support clinical trials.” Sundgren. “Clinical studies will be conducted in closer
collaboration with hospitals, in which observational studies
The attrition rate is a big problem, and data from EHRs inform the pre-design of studies and the
with only 2–5% of projects actually way they’re conducted. I also foresee that they will involve
considerably fewer patients, which will help address the
hitting the market. So there’s huge extremely high economic price that studies face today.”
pressure on the industry, and that’s This emphasis on data is not confined to static hospital
reflected in clinical trials. records. It also extends to real-time patient monitoring, using
sensors connected to mobile devices. This should provide a
much clearer tool for understanding how the drug is working
The advantages are obvious. With more information required and help steer its passage to the clinic.
than before, sourcing such data in isolation is likely to prove “Everyone has to win in this situation,” says Sundgren.
time-consuming and costly. Reusing EHRs represents nothing “We can probably improve the attrition rate and heighten
less than a breakthrough opportunity for the industry. our success in taking drugs to market, although what will
Of course, this undertaking is not without its pitfalls, legally, change is that each drug will have a very limited and
ethically and technically. For the pharma industry to connect specified indication.”
its internal health information domain with external records, it The EHR4CR project still has over two years left to run. As it
will need to take an unprecedentedly collaborative approach. edges closer to developing a robust and scalable business
“We need to connect more closely to healthcare, not only model, its points of focus are indicative of a broader shift
because healthcare institutions are the original owners of within the industry. No longer are pharma companies content
information sources like EHRs, but also because developing to stick within outdated frameworks. They are united in their
new biomarkers will bring us into close collaboration with search for building blocks that will help a drug move more
many partners simultaneously,” says Sundgren. “There is an effectively towards its launch.
opportunity for pharma companies to work not just with Encouragingly, top-down change is happening in tandem
hospitals but also with other pharma companies in with bottom-up. If the FDA has been slow to evolve, a more
precompetitive arenas.” welcoming approach to innovation is on the cards.
“We are evaluating our regulatory approach to clinical trial
Collaborative incentive oversight to ensure it meets our objectives without being
Sundgren does not believe that pooling information will unnecessarily burdensome or unduly impeding implantation of
come about through sheer goodwill. Rather, those involved innovative approaches,” says Bolek.
will be offered a financial incentive, along with an element As these approaches take shape, the stage is set for a new
of accreditation. type of clinical trial – one in which the design is better suited to
“The new business models will need to govern and regulate a field undergoing constant shake-ups. For the industry, this is a
the financial implications of reusing data in a trustworthy cost and time-saver. For patients, it’s a genuine revolution. ■
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