Lisa Henderson

Dr. Salim Idriss, Executive co-director of the Duke Pediatric and Congenital Heart Center & director of pediatric electrophysiology at Duke University Medical Center discusses a collaboration with the Cardiac Safety Research Consortium (CSRC), the FDA, and Duke University Medical school.

Podcasts

The Need For Pediatric Clinical Trials and Data

Patient recruitment remains the largest impediment to clinical trials progress. Barriers to participation are numerous and as noted in this 

, can be broken down into these buckets on the recruitment progression cycle—awareness, identification, information and consent, patient-centric operations, and accelerated regulatory approval. Each of these buckets or progressions contain a plethora of ideas, strategies, technologies, and choices. And at any one of these progressions, a potential participant can be lost.

The reality of patient recruitment is that its success depends on those myriad factors under the buckets, in addition to an individual’s behavior or personal beliefs. According to survey results in this 

 from IQVIA, “When asked what prevents them from participating in a trial, fears about their health and safety (62%) far outweighed concerns about time (37%), logistics (18%), and negative press about research (8%).” Further influences can be analyzed by gender, race, and ethnicity, all coalescing around choosing to participate.

In this issue, we present a fraction of the exhaustive list of options that currently exist to foster recruitment. 

, for example, where potential participants can learn, discuss, and express interest in a clinical trial for a near-future opportunity to participate and remain engaged. Sharing clinical trial results with 

 is a way to engage younger generations, as well as their parents or caregivers by providing transparency into the process. Tufts CSDD offers 

 to sponsors and CROs on how to re-prioritize routine assessment of patient satisfaction as a primary outcome measure. And our 

 offers an overview of recent technologies such as patient opt-in solutions; EMR funnels to find appropriate patients for outreach by physicians; and solutions that find and monitor participants in the community via pharmacies such as CVS or Walgreens.

In this issue, we purposely did not highlight decentralized trials, which offers components that improve patient participation and experience under the patient-centric operations bucket.

Starting or piloting any new initiative to increase patient recruitment is a plus. Whatever you can do to increase the exposure and access for the potential of a clinical trial participation will help. Remember, “You miss 100% of the shots you don’t take.” 

 is Editor-in-Chief of Applied Clinical Trials. She can be reached at 

Articles

ACT presents solutions to foster greater participation in May issue.

Patient Participation is a Team Sport

Associate editor, Andy Studna, talks with Editorial Director, Lisa Henderson, about her recent travels to various industry conferences, the insights she gained from them, and a review/preview of recent issues.

Industry Updates From the Road

Pamela B. Davis, MD, PhD, Professor of General Medical Sciences at Case Western Reserve University School of Medicine and Member of the Board of Directors for the Clinical Research Forum, discusses the clinical research industry, her own career, and the article that she and her colleague Dr. Wu wrote for Applied Clinical Trials.

What Academic Research and Industry Can Learn From Each Other

The decentralized clinical trial (DCT) movement has become the “it” word in the post-pandemic clinical trials world. In cases of enormous hype, where a term is used over and over, as well as used as an umbrella term to mean multiple things, it becomes less descriptive and, therefore, more confusing.

Now when decentralized clinical trial articles are submitted to our editors, they must begin with what the core article topic is…not decentralized trials, not a historical restating of the facts of how DCTs came to be…not a reairing of all the possible benefits DCTs could bring to the industry. No. What we need now are specifics. Directions. Best practices. Or even things that were tried and didn’t work well.

But what I will concede is that DCTs have brought a whole new cast of characters into the clinical trials mix. And old characters proving that adaptability makes competitive sense.

For a complete and thorough explanation of an example of the new cast of characters, please read our 

. Here we learn about the challenges of the digital therapeutics industry and how it has grabbed on to DCTs as a way to more easily, and hopefully less expensively, acquire the needed quality data to ensure, at the minimum, outcomes evidence, and, at the maximum, FDA approval. With digital therapeutics, decentralized clinical trials providers such as Curavit Clinical Research or Curebase see a natural kinship or extension of those products with their digitally optimized clinical trials processes. While not the same pathway as a CDER- or CBER-based clinical trial, the needs for patient safety and scientific rigor are no less for a digital therapeutic that is going to make a claim to prevent, manage, or treat a medical disease or disorder.

As for traditional CRO providers, including Rho and PPD, their contributions to advancing DCTs can be found online. Rho has developed its RBQM strategies around a whole new host of 

 that can arise in a DCTs. And PPD’s example of using a mobile RV, a literal DCT on wheels, to ensure the continued participation of a rare disease participant. And again in an 

, designing the protocol so that both investigator and participant could customize their trial to fit the patient’s needs.

We look forward to sharing the use cases, examples, best practices, and more for the hybridization of clinical trials. “Decentralized” may have worn out its welcome, but the term sticks.

DCTs’ Broader and Multifaceted Implications

Mike Rousselle, Vice President of Data Product for OptimizeRx, discusses his serendipitous career, current role, how the company ties AI and RWE together for trial recruitment, and more.