Accelerating clinical trials during an epidemic

Map of Ebola outbreak stock image clinical trials epidemic

Map of Ebola outbreak – October, 2014

How should clinical trials be executed during a crisis such as an epidemic? Which aspects, if any, of the clinical trial process will change? Who needs to be involved and when do people need to act to ensure efficient management of the research? The National Academies of Sciences, Engineering, and Medicine (NASEM) turned to the 2014 Ebola epidemic as a case study to answer these questions and others.

The Office of the Assistant Secretary for Preparedness and Response, the National Institute of Allergy and Infectious Disease, and the US Food and Drug Administration (FDA) tasked NASEM to analyze clinical trials conducted in West Africa during the Ebola epidemic. Upon completing their analysis, NASEM recommended ways to improve and accelerate clinical trial research during future infectious disease outbreaks. The committee determined that randomized clinical trials (RCTs) are “both ethical and preferable in the context of an epidemic as RCTs provide the fastest way to identify beneficial treatments and vaccines while minimizing risk.”1 Michelle Mancher, program officer for the NASEM report, explained that “during the Ebola outbreak, while the trial teams moved at lightning speeds, the trials started after the peak of the epidemic and were still too late… to be successful in the future, work will have to be done during and between outbreaks” during in an interview. The NASEM report covers three recommended focus areas: communication and community engagement, capacity strengthening, and internal coordination and collaboration.

The global community and CROs

Effectively responding to the next epidemic and preventing future epidemics will require a global effort. Healthcare providers, life science professionals, the at-risk population, and others all have roles to play. Contract research organizations (CROs) must participate as well. “During a future epidemic,” Mancher explains, “when time is of the essence, CROs can play critical logistical support roles for clinical trial teams…For example, to immediately address the technical or infrastructure demands, including establishing contracts to secure clinical monitoring, safety monitoring, data management, and cold chain assistance.”1

Assuming clinical trials can be planned and coordinated efficiently and without delay after and during an outbreak is “unrealistic” according to Mancher. Work needs to be done in the interim, before and between epidemics, to ensure the best response can be administered quickly to reduce a disease’s impact on a given population.

Our AAHRPP accredited independent review board can promptly review your next study to prepare for human subject trials. Contact Pearl IRB for more information. Looking for support services for your clinical research such as safety monitoring, data management, quality services, etc.? Contact us at Pearl Pathways to learn more about our niche CRO offerings.



New FDA draft guidance points to problems with multiple endpoints in clinical trials

FDA clinical trials draft guidanceThe US FDA released draft guidance this week on the “problems posed by multiple endpoints in the analysis and interpretation of study results and how these problems can be managed in drug and biologic clinical trials,” Zachary Brennan of RAPS reports. The FDA justifies the guidance due to the greater likelihood of making false conclusions about the effects of a given drug as the number of endpoints in a single clinical trial increases.

The FDA states that the guidance serves to “describe various strategies for grouping and ordering endpoints for analysis and applying some well-organized statistical methods for managing multiplicity within a study in order to control the chance of making erroneous conclusions about a drug’s effects.” (FDA Draft Guidance). Efficacy endpoints measure a drug’s effects. They may include assessments of clinical events (e.g. mortality, pulmonary exacerbation), patient symptoms (e.g. pain, depression), measures of function (e.g. ability to walk or exercise), or surrogates of these events or symptoms. The draft guidance lists the three families for classifying endpoints within a clinical trial: primary, secondary, and exploratory. To demonstrate the study objective of effectiveness, a statistical analysis must be performed to rule out chance as the explanation for a trial’s results. The guidance goes on to discuss the test of hypothesis and several other statistical methods used within clinical research to test against the probability of chance.

The FDA’s explanation of various statistical models and their usage cases dominates the rest of the draft guidance. However, this in-depth analysis drives home the message of this guidance. The FDA states that “the chance of making a false positive conclusion, concluding that a drug has a beneficial effect when it does not, is of primary concern” (FDA Draft Guidance). Our team of experts at Pearl IRB strive to stay up to date with FDA’s guidance to ensure that our clients remain informed about the necessary regulations. This allows clinical trials to run smoothly as our clients march towards product commercialization. If you have a study that needs reviewed or are in the beginning phases of research for a new treatment, please contact us today.

Pearl IRB’s co -chair, Dr. Gretchen Parker published in Cureus

Gretchen Parker, PhD, RAC, CIP, and Pearl IRB Co-Chair, has completed another article published by Cureus.  The title of the article is “A Framework for Navigating Institutional Review Board (IRB) Oversight in the Complicated Zone of Research”.  The article provides Parker’s unique perspective on IRB processes and review types, offers insight into the IRB decision-making process, and emphasizes the importance of engaging an IRB consultant early in the clinical study design process.

Pearl Pathways’ own Diana Caldwell moderator at upcoming ACRP Circle City Chapter Symposium

CircleCity_Blue (1)Reminder to register for the October 3rd ACRP Circle City Chapter 16th annual fall symposium at the Ritz Charles in Carmel, IN.  Pearl Pathways’ CEO and President Diana Caldwell will moderate a panel discussion of The Future of Research in Indiana.  There will be additional discussions on clinical research throughout the day and an excellent opportunity for networking with other research professionals.  For a look at the agenda and to register click here.  You can learn more about ACRP Circle City Chapter and the benefits of being an active member at this link.

ACRP Circle City Chapter Symposium on October 3

CircleCity_Blue (1)On Monday, October 3rd, the ACRP Circle City Chapter will be hosting their 16th Annual Excellence in Clinical Research Symposium at the Ritz Charles in Carmel, Indiana.  Save the date for this event which will be held from 7:30am to 5:00pm.  Registration and agenda will be available soon.  For more information about the event, click here and contact Circle City ACRP at this link.

It’s time to take a look at human subjects research regulations

The National Academies of Sciences, Engineering and Medicine released a new report in late June that looks at federally funded research and is now recommending an independent commission be established to take a close look at ethical and legal issues of human subjects research and update policies to address the new research landscape of today.

The report recommends that several gaps be addressed and that an independent commission look at how principles of human subjects research should be applied to:

  • Research involving anonymous and de-identified human biospecimens
  • Research involving large data sets
  • Clinical trials where the unit of intervention is a cluster or group
  • Clinical studies comparing the effectiveness of different accepted interventions for a disorder to determine whether one approach may be preferable
  • Research aimed at clinical innovation and quality assurance and improvement

The Belmont Report, created years ago in the late 70’s, identifies the principles to guide research involving humans.  With the advancements in knowledge and technology since that time, it is apparent that many questions arise about how those principles should be applied in today’s research environment.

“Congress and the administration have an opportunity for a course correction that can yield significantly greater value to the public from the nation’s investment in research, and we hope our recommendations will guide that effort,” said Larry Faulkner, chair of the committee that wrote the report and president emeritus at the University of Texas, Austin.

For more information, check out Melissa Fassbender’s article in Outsourcing Pharma.  Follow this link to the press release from the National Academies of Sciences, Engineering and Medicine.  Pearl IRB is dedicated to sharing informative issues in research.

Reflections on the ACRP 2016 Meeting and Expo

The Association of Clinical Research Professionals (ACRP) 2016 Meeting & Expo was recently held in Atlanta and I always enjoy attending. It gives me the chance to interact with colleagues from all over the world and become more educated on topics and situations affecting clinical research.

This year I was truly inspired by one of the Keynote Speakers, Martine Rothblatt PhD, MBA, JD founder of Sirius Satellite Radio and United Therapeutics She shared her story about her quest to find a drug that would save her daughter from a rare disease. Rothblatt’s innovation and persistence paid off. She was able to find and develop a drug that was about to be put on the shelf at a large drug manufacturer. The drug, Remodulin, saved her daughter’s life.

The work we all do in clinical research is important, no matter what our roles are, because ultimately we are working toward the same goal…bringing safe and effective products to patients that cure diseases, save lives or improve their quality of life.

Remote Based Monitoring – new technology for clinical study data

Remote Based Monitoring (RBM) is technology that allows for remote access to data which has application for use in clinical studies. Melissa Fassbender, Outsourcing, recently published an article about RBM. Fassbender gave details where Propeller Health is partnering with GlaxoSmithKline to make a sensor used with a dry powder inhaler. The sensor automatically monitors the patient’s use, date and time, for clinical trial data.

Fassbender’s article mentioned that one benefit to RBM is having increased accessibility to data and this convenience will likely keep clinical trials running where in the past, people may have dropped out due to inconvenience. Remote Based Monitoring is expected to grow and CROs implementing it first may have a competitive advantage.

To read Fassbender’s article on this technology for clinical studies, please click here. Pearl Pathways would like to partner with you in this exciting technology, contact us.

Breast cancer patients use behavioral health app for research

Wearables, such as the Apple Watch, are becoming more commonly used in clinical research, as mentioned in a previous blog post. Most recently, as stated by Stacy Lawrence of Fierce Medical Devices, researchers at the MD Anderson Cancer Center at Cooper are using the Apple Watch in a 9-month study to analyze the basic health data of breast cancer patients as they undergo treatment.


Polaris Health, a behavioral health tech company, created the app that will be used, emPOWER. Not only will the app track the patients’ physical health, it will track their mindset and behavioral health, such as sleeping habits and moods. Dr. Generosa Grana of MD Anderson Cancer Center at Cooper stated, “A positive frame of mind can help patients through all phases of their diagnosis and treatment.” Going forward, it will be interesting to see the impact wearables have on the clinical research industry and on healthcare.


Click here to read Lawrence’s article. To access the press release, click here.

Inclusion of women in clinical research still too small

The Government Accountability Office (GAO) recently released a report in regard to women in clinical research. While past efforts by the National Institutes of Health (NIH) have increased the number of women involved in research, further changes are still necessary. eNews Park Forest’s press release includes statements from Senators in support of the report. Since diseases and treatments impact men and women differently, it is important for the NIH to generate more data from women in order to develop effective solutions and scientific advances.

To get more details, check out eNews Park Forest’s press release here.