It Is Time To Prioritize Study Participants

Recently we attended the Clinical Trials and Internet of Things forum, held in Boston’s Longwood medical area. It was an exciting two days of biopharma, technology companies and CROs coming together to discuss the potential of wearables, sensors, and mobile devices to transform clinical research.  However one speaker, Jack Whelan, struck us as a unique voice in the conversation. Seven years ago Jack was diagnosed with a rare blood cancer he refers to as “not yet curable.” Since then he has participated in six clinical trials and transformed from an IT Research Analyst into a Research Advocate. Jake took the audience through many of the issues he’s faced as a participant in the clinical research process and offhandedly joked at one point about having never one received a thank-you note from an sponsor or investigator, much less any sort of feedback on the results of the trial.

How could this be?  How could we not be thanking participants, many of which, whom are going through one of the toughest parts of their lives for support clinical research? It is no wonder that the National Academies Press (NAP), cites patient dropout rates in phase III “can often be very substantial,” exceeding 30% at times.

However, patient dropout is not a new issue; it is a long-standing challenge in clinical studies. A piece on the subject from 2012 talks about the challenges of patient dropout and includes in their recommendation for retention include:

  • Is ample parking available?
  • Is the waiting room inviting?
  • Are scheduled appointments kept timely?

Jack shared the challenges of his wife navigating Fenway Park traffic during a Red Sox game while trying to make it home to the suburbs from medical appointments in Longwood. Though these practical recommendations are undoubtedly low-hanging fruit for many, they are a small part of the problem if the participant has to drive hundreds of miles or fly hours to get to the site. This is often the case, especially in less common diseases that are supported by fewer, disparate research centers. Throughout the entire clinical research process, subject interests aren’t consistently prioritized. All of us involved in research have a responsibility to put study participant first and honor the commitment of people like Jack.

The growing volume of user-friendly technology introduces new considerations:

  • Is it possible to leverage telemedicine for the PI check in with participants?
  • Can sensors / wearables passively collect relevant data to not interrupt the life of a study participant?
  • Can mobile devices be used to conduct assessments and capture data that currently rely on site visits?

Companies such as Transparency Life Sciences are already making strides in incorporation of technology into study designs. TLS is piloting telemedicine technology in both their Multiple Sclerosis and Ulcerative Colitis studies. Notably, they are using a combination of the local physicians, mobile visits from a nurse, as well as videoconferences with a PI to put the participant’s experience at the center of the study.  

This is just the beginning of recent innovation in clinical studies. There will be a variety items tested; some will succeed, some will fail, but all represent an opportunity to learn how to prioritize the patient experience.

  1. National Academy of Sciences. The Prevention and Treatment of Missing Data in Clinical Trials.Washington, D.C.: National Academies Press; 2010. Available at:
  2. Patient Retention: Minimize Dropout Rates Simply and Effectively By Dawn Burke Product Marketing Manager, Forte Research Systems, November 1st, 2012

By Matt Cantor, VP of Business OPS at Koneksa Health