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.



Clinical trials and pharmaceuticals adapt to growing digital health market

digital health wearableDescribing the rise of medical “wearables” in the U.S. and global marketplace as meteoric seems fitting given the rapid growth of the industry over the past decade. Wearable technology has been around for decades (check out an amusing history of some medical and not-so-medical wearables here), but mainstream adoption of the technology occurred more recently. Fitbit entered the scene in 2009 followed by several offshoots. Pebble kicked off the smartwatch craze just five years ago, in 2012. Now, one in six consumers in the United States currently use wearable tech such as the aforementioned fitness bands and smartwatches1. This trend will not slow any time soon, as the industry could see more than 3x growth in the next few years, expanding from $5.1 billion in 2015 to $18.9 billion in 20202. How will the expansion of medical wearables impact the life sciences industry?

An article on Insights, a division of Samsung focused on researching how their devices are used by everyday people in everyday life, reports on the adoption of digital health tech in clinical trials and pharmaceuticals. The article cites a survey by digital health technology vendor, Validic, on how digital health devices and data impact clinical trials:

  • “Sixty percent of respondents said they have used digital health technology to conduct clinical trials.
  • Ninety-seven percent of respondents said they will increase their use of digital technologies in clinical trials in the next five years.
  • Mobile apps and in-home clinical-grade devices are currently the most commonly used devices in clinical drug trials, but wearable activity trackers and sensors will be the focus of future use.
  • Seventy percent of respondents said patient-generated health data (PGHD) could have the greatest impact on improving treatments for chronically ill populations.”3

Current consumer-grade wearables are accessible and powerful, but a number of companies see the need to advance the use of clinical-grade devices as well. For example, the Insights article notes a collaboration between Validic and Sutter Health with the Office of National Coordinator for Health Information Technology. Their pilot project aims to determine how to best deliver patient generated health data (PGHD) to healthcare clinicians and researchers. The project “monitors and collects data from Sutter Health patients with Type2 diabetes through the SutterMpower app, which connects to devices measuring patient blood glucose, blood pressure, weight, and activity level.”3.

Medical wearables make remote monitoring of patients a powerful option for clinicians. The Insights article describes another pilot study that explores if patient hospitalization can be avoided through the combination of clinician visits to patient homes and advanced continuous electronic digital patient monitoring. In addition to improving an individual’s health, digital health tech could also reduce healthcare costs. Insights references a study published in The American Journal of Managed Care that analyzed anonymized medical and pharmacy claims data from over 1.2m patients with diabetes, high blood pressure, or high cholesterol. It was found that “payers could save approximately $38 million to $63 million per 100,000 members by deploying resources for improving medication adherence in specific patient populations.”3.

Digital health technology’s transformation of the health care and life science industries has just begun. Medical wearables bring opportunities for individual consumers to track and assess personal vital health information. Health care and life science professionals face the challenge of managing and analyzing this data while continuing to find innovative and safe ways to improve patient health while maintaining the confidentiality of private health data. Our team of experts at Pearl IRB can promptly review your study to prepare for human subject trials or support your company’s efforts to develop new digital health devices by navigate the changing regulatory landscape impacting these products.





EMA finds development challenges for medicines targeting CNS disorders in new report

The European Medicines Agency (EMA) released a report on Tuesday that analyzed over 100 applications submitted for medicines in the fields of psychiatry or neurology between 1995 and 2014. In the report, EMA concludes that various challenges can arise in the development of medicines targeting central nervous system (CNS) disorders and stresses the importance of appropriate design of early-stage clinical trials for future development success.

Complexity of research for CNS medicines adds to the challenge of successful drug development; EMA cites a “higher rate of failure during the clinical development of these products compared to other fields of medicine” in their report. Of the 103 applications received by EMA’s Committee for Medical Products for Human Use (CHMP), 57 were neurology products and 46 were psychiatry, and 29 were rejected or withdrawn leaving 74 that received approval. Submitted drugs targeted schizophrenia, MDD, Alzheimer’s disease, epilepsy, and more.

EMA’s claim that appropriate design of early-stage clinical trials is not ungrounded in fact. The analysis explains that “over 50% of the applications that had major problems with the outcome confirmatory study (in terms of efficacy and/or safety) also had issues in the early clinical development.” The chart below visualizes the report’s findings and the differences in the types of issues raised for neurology medicines and psychiatry medicines.

EMA report chart


Appropriate design of early-stage clinical trials is vital for resulting in efficacious results, and Pearl IRB is here to help. Please contact us to set up a discussion with our team of experts to assist with your drug or device clinical trials.

Advice from the experts: How to set up a successful community-based clinical trials program

Clinical research, when done correctly, provides a plethora of benefits to the researchers involved in the process as well as patients enrolled in the trials. Setting up a successful clinical trial process was the topic of a recent breakout session led by Daniel R. Saltzstein, MD and Lawrence Karsh, MD at the 2016 Large Urology Group Practice Association (LUGPA) Annual Meeting.

The two experts, as reported by, detailed several reasons why physicians should participate in clinical research. First and foremost, clinical research can contribute to the “greater good” of society by providing front-line therapies to patients in need at no cost. Karsh went on to explain the professional benefits clinical research provides as well: an ancillary revenue stream, increased number of publications, and credibility among the medical community. Karsh, who currently manages 35 trials that are either enrolling participants or ongoing, admits that he “think[s] it’s a huge bonus to learn how to use therapies before they even enter the market because it gives you the edge against other practices, [but] be clear that this won’t be a windfall and you can even lose money if it is not managed properly.”

Community physicians can be better strategic partners for pharmaceutical companies because they are able to “review proposals and contracts faster, recruit patients more rapidly, and offer an overall lower trial cost and greater diversity of [treatment states in their] patient base,” Saltzstein advises. Saltzstein and Karsh go on to list the vital positions for a successful clinical research program:

  1. Principal investigators
  2. Sub-investigators
  3. Director of research
  4. Study coordinators
  5. Data entry professional
  6. Recruiter and data miner to identify patients

Physical space within the clinic should not be forgotten either. Karsh suggests that “choosing space within eyeshot of referring doctors” helps keep the research program top of mind. Another key factor not to dismiss is earning buy-ins from colleagues. A coherent, well defined benefit statement of the program’s impact on patients and the clinic should be communicated to each participant. A prosperous program cannot be built overnight, as Karsh concludes that it “takes time and experience to start a research program – you will definitely go through some struggles… but the more trials you do, and do well, your name gets out and companies will come to you.”

For help from our experts at Pearl IRB on establishing or fine-tuning your clinical research program, please contact us to begin a conversation.

Check out ACRP’s new, free training program for Clinical Research Professionals

A press release from The Association of Clinical Research Professionals (ACRP) announces a new educational training program, “Introduction to Clinical Trials”.  This presentation was introduced at DIA 2016 in Philadelphia, PA in late June and provides an excellent primer of clinical research.  ACRP sees their role in professional education as critical.  “ACRP is proud to offer this fundamental education in support of our mission to promote excellence in clinical research,” says Jim Kremidas, ACRP Executive Director. “As the leader in clinical research workforce development, providing those new to the profession with a core understanding of clinical research is a critical initiative for ACRP. We are thrilled to be able to freely provide this program to individuals, clinical trial sites, contract research organizations, and trial sponsors and suppliers. Thank you to Labconnect LLC for providing ACRP the educational grant to develop this program.”

Pearl IRB is spreading the word about clinical research and encourages you to join in for this free, online course. To read more about the course and to register, click here. Need more advanced GCP or other training for your research staff? Contact us now to learn about our Pearls of Wisdom Training Series.

Empowered Patients in Clinical Trials

Reading an article by Ed Miseta, Clinical Leader, brought to mind the importance of the balance of patient’s needs and scientific advancement.  Miseta’s article shared comments from leaders in Pharma where empowered patients and their community voice is recognized and discussed.  Clinical trial design that includes patient input and discussions for “buy in” is a way to encourage participation in clinical trials and keep the enrollment going throughout.  Patients are not only patients but people just trying to get through their days, working, family, friends and activities.  Good to know that thought leaders are having these important discussions, like the one at the CROWN Congress, and implementing new ideas in clinical trials.  Miseta’s article is a good read — I encourage you to look it over.

Getting the word out about clinical trials

Melissa Fassbender, of OutSourcing-Pharma, published an article about a SubjectWell survey on Clinical Trial Awareness and Attitudes. For those surveyed: 50% are not aware of clinical trials and 57% could not recall any advertising for clinical trials.

The lack of awareness suggests that pharma and even CRO’s need to get the word out to the public when rolling out clinical trials. Many people who have an interest in being part of advancing science are not aware of what studies exist. Have ideas on increasing the awareness of the importance of clinical trials and how to volunteer? Let us know. Pearl IRB can help with your clinical trial management with IRB reviews and more — contact us to partner on your next study.

Buch updates on FDA’s progress made for clinical trials

Barbara D. Buch, M.D., Chair of the 907 Steering committee and the Associate Director for Medicine in FDA’s Center for Biologics Evaluation and Research, recently posted on FDA Voice her reflections on a focused action plan to support inclusion of diverse populations in clinical trials. The plan focused on addressing quality, participation and transparency of data in clinical trials.

For improving quality of data collection, progress was reported in training and outreach of guidance on demographic data, modifications to clinical review templates for better inclusion of diverse populations, and more.

To meet the goal of increased participation, Dr. Buch shared that a workshop was held to discuss the importance of diversity in clinical trials, and she reported that clinical trial demographic information is now easily available online for consumers.

To improve transparency, FDA reported that a Language Access Plan Working Group was established for new communication strategies to reach those under-represented, and a pilot program was formed to make demographic information available for Biologics License Applications, and more.

Read Buch’s entire article here for more details on the progress made. Contact Pearl IRB for experienced assistance in your clinical research.

Join in Upcoming Life Sciences Lunch Series, February 16th with Diana Caldwell as panelist

The Indiana Health Industry Forum (IHIF) and Barnes & Thornburg present “Clinical Trials from a Study Site Perspective” featuring Pearl Pathways’ own President and CEO, Diana Caldwell as a panelist. This presentation and luncheon will be held on February 16th at the Barnes & Thornburg office at 11 S. Meridian Street in downtown Indianapolis, 11:30 – 1:00pm. Learn more and register today.

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.