Throughout 2021 we’ll take a look at the latest developments in the realm of Decentralized Clinical Trials. Read this monthly roundup to discover the latest trends, insights, and modalities of decentralized clinical trials.
This past February, our blog focused on the various entry points involved in moving trials to a fully Decentralized Clinical Trial (DCT). Although our industry is gaining familiarity with this new approach to clinical development, several questions remain. One of the most important we find our customers asking is “Where do I start?”.
In February we dug into a couple of key entry points. The first has to do with electronic clinical outcome assessments (eCOA’s). The second has to do with enabling the voice of the patient.
Before we look at our recap, let’s first define Decentralized Clinical Trials (DCT’s) for those who have found this blog as their entry point in education. DCTs differ from traditional clinical trials by bringing the trial to the patient through a combination of technologies (eConsent, eCOA, TeleVisits, Sensors & Wearables), mobile/local healthcare providers, and enabling the voice of the patient. Thus, there are a variety of modalities that can be used as an entry point in decentralizing a trial, whether through consent, outcomes reporting, or site visits. Regardless of the point of entry, the solution must be tailored in a flexible and modular manner to fit the unique needs of an indication, therapy, or patient population.
Our own Dr. Ingrid Oakley-Girvan began the month by delving into:
In the blog, Dr. Oakley-Girvan dives into the four categories of Clinical Outcome Assessments spanning Patient Reported Outcomes (PRO), Performance Outcomes (PerfO), Clinician Reported Outcomes (ClinRO), and Observer Reported Outcomes (ObsRO). She also examines the suitability of each outcome assessment for decentralization and how each can be measured remotely through various technologies and processes.
Next, our own Dr. Reem Yunis took a deeper look into the most popular form of eCOAs, Electronic Patient Reported Outcomes (ePRO):
In the blog, Dr. Yunis charts the path our industry has taken from paper based patient reported outcomes to electronic. Important factors she highlights for consideration in the blog include the modality and device type a PRO is presented on as well as the challenges presented in achieving compliance. Both are factors which are heavily influenced by patient engagement and compliance.
Over the past year Medable has been expanding it’s Patient Advisory Council and this February we announced the following:
Our four new PAC members include:
Sumaira Ahmed: a marketing director at Brigham & Women’s Hospital in Boston. Shortly after being diagnosed with sero-negative Neuromyelitis Optica Spectrum Disorder (NMOSD) in 2014, she founded The Sumaira Foundation to raise global awareness and find a cure for NMO.
Gaurav Dave, MD: an Associate Professor of Medicine, Associate Director of the Center for Health Equity Research, and Director of Abacus Evaluation Consulting at the University of North Carolina at Chapel Hill.
Allison Kalloo, MPH: a patient recruitment specialist and the founder of Clinical Ambassador, iParticipate and CliniVIVRE aimed at expanding minority access and impacting diversity, equity and inclusion in clinical research.
Paul Kidwell: a Boston-based public relations and patient advocacy consultant, providing media relations and patient engagement support for biopharmaceutical companies, and a rare disease podcaster.
In this blog Mr. Kidwell highlights some of the unsung heroes of our healthcare system: caregivers. He shares his personal experience of being thrust into the role. Just as “nobody expects to get sick until they do, for caregivers, this sentiment is exactly the same. The role and its inherent demands are never part of a person’s thinking”
During the podcast, Ms Ahmed shares her story around Neuromyelitis optica and how she started a foundation that's mission is to amplify NMO patient voices and raise money for researching a cure.
Allison Kalloo and Sumaira Ahmed investigated the legacy of Henrietta Lacks through different prisms, one focused on her impact on medical research and the other on how betraying public trust can have far-reaching and longstanding implications that we will continue to confront for some time.
Giving voice to the patient perspective will be critical to the ongoing success of Decentralized Clinical Trials (DCT’s). And we at Medable are honored and humbled by the work members of the Patient Advisory Council do every day to make these voices heard. Doing so is critical to entering DCT’s with the right perspective.
As February turns to March, we at Medable will continue to look forward to how we can continue to operationalize DCT’s and help patients, sites, CRO’s, and sponsors to realize the full benefits of this powerful new modality of clinical research. In March we’ll turn our attention to overcoming implementation and planning obstacles related to DCT’s.