How a Clinical Trial Participant Would Use a Magic Wand to Reform Future Clinical Trials
By Gunnar Esiason, Principal Key Opinion Leader of Patient Strategy at Florence Healthcare
A few weeks ago, I came across an article that detailed the reforms life sciences executives would make to clinical trials if given a magic wand. I’ve participated in several interventional clinical trials over the last decade, so I was inspired to pick up the proverbial magic wand and make some of my own changes – even if they seem a little farfetched in today’s clinical research climate.
For me, it boils down to improving the experience for patients inside lengthy clinical trials because I have found that experience is directly tied to my enrollment choice. Often, the reason I’m hesitant to join a clinical trial isn’t because of the drug at the heart of it, but instead it’s the parameters of the trial itself.
If you’re in the industry, then you broadly know the kinds of challenges that shape clinical trial experiences for better or worse – the time commitment, travel, invasiveness, side effects, lifestyle changes, inconvenience, illness, and general uncertainty that comes with a placebo-controlled trial.
The first three levers I would pull to tackle those challenges are participant compensation, where clinical trials are positioned in the care continuum, and wearable validity.
Increasing compensation for clinical trial participants is long overdue. I’ve written and spoken about clinical trial pay at length, but in short, participants are not adequately compensated for their time and contribution to medical research, and this necessarily impacts a willingness to participate if a trial protocol is asking someone to skip out on every other part of their life for a period of time. By increasing compensation, and with the right ethical controls (appropriate therapeutic areas, trial phase, underlying efficacy and safety data), the tradeoff becomes a market informed choice, and therefore can make clinical trials more accessible and attractive to a broader range of participants, without being coercive.
My next wave of the magic wand would shift where clinical trials sit in the broader care delivery ecosystem. I’ll use clinical research as a care option to define this change. From the outside looking in, it might sort of seem like clinical trials are something akin to a typical visit to a specialty clinic or doctor’s office, but they really aren’t. Clinical trials are othered from typical medical care. Clinical research as a care option (CRAACO) aims to narrow the gap between typical medical care and clinical trials. Essentially, the model provides participants with access to additional medical care and support beyond what is strictly necessary for the trial, with the goal of improving the overall health and well-being of participants. This extra support can address health concerns or needs that are not directly related to the trial, but that are important to the participant’s overall well-being. An additional key benefit is that trials suddenly feel more familiar to typical medical care. Medical centers can already feel like foreign places for patients trapped inside their bureaucracy, with research wings magnifying the feeling. CRACCO aims to get rid of that magnifying glass.
My last wave of the magic wand assumes some baseline data capture validity is already in place. I really do think wearable devices can revolutionize the collection of health-related data in clinical trials, and, critically, reduce the travel and site visit burden for participants. For investigators, wearables offer the potential to provide more comprehensive and continuous information in natural settings. With wearables, data collection becomes a passive activity. For patients, though, I see wearables as an exit to the monotonous existence inside clinical trial study visit after study visit. I use wearables broadly and somewhat imprecisely because technology needs to take a big step forward to bring this vision to a reality. I can’t help but think about how much easier my life would be as a participant if my pulmonary function could be measured in some way other than a trip to a pulmonary function lab!
Maybe some of this is farfetched, but in sum the goal here is to get the industry to think about patient experience more from the participant side and less from medical provider side. We all know clinical trial enrollment is slow, costly, and hard. The path to alleviating enrollment issues necessarily includes improving the participant experience, and to do that I’d start the conversation with compensation, the care continuum, and passive data collection. What would you do with your magic wand?
About the Author
Gunnar Esiason is a cystic fibrosis and rare disease patient leader, who is passionate about early-stage drug development, patient empowerment and health policy. Professionally, he developed a patient engagement platform for a medical nutrition company, built a venture philanthropy practice at the Boomer Esiason Foundation and was the head coach of his high school alma mater’s varsity hockey team. He has consulted on clinical trial development, a real-world evidence population health study, and a cystic fibrosis-specific mental health and wellness screening tool. Gunnar has been the face of fundraising efforts for the Boomer Esiason Foundation, which has yielded more than $160 million for the fight against cystic fibrosis since he was diagnosed with the condition in 1993.
Gunnar holds an M.B.A. from the Tuck School of Business at Dartmouth, an M.P.H. from the Dartmouth Institute for Health Policy & Clinical Practice, and a B.A. from Boston College.
He sits on the board of directors at the Boomer Esiason Foundation and No Patient Left Behind.
Follow him on Twitter @G17Esiason