On the Future of Decentralized Clinical Trials
Reveles founder and CEO, R’Kes Starling, was recently among a trio of industry leaders interviewed by FirstWord for a report on decentralized clinical trials (DCT). The following are a few excerpts from his remarks.
What types of trials are right for a decentralized approach?
“I like to say that DCTs are a privilege, not a right, meaning not every trial, not every patient, not every scenario is right for the DCT model. You have to consider the conditions of the home, the acuity of the patient, and patient support systems because now you are shifting some of the burdens onto the patient. Simple things like electricity, running water, and a clean private space are important for healthcare professionals coming into the home. These are things that you need to be very mindful of.”
What will a successful DCT look like?
“A successful DCT will demonstrate patient satisfaction, data quality, traditional enrolment targets, completions, and retention. It will also include return on investment, the total cost of care, and total costs from the lab to launch. Also, folks are going to want to know If you can prove that incorporating DCTs accelerates the move from lab to launch and if it played a very meaningful role in that continuum.”
What is the objection to DCTs?
“Data privacy is typically the number one factor cited for why people do not want to move to DCTs. The thing is that DCTs are no different than traditional trials in this respect. We need to make sure we have the right safeguards in place to ensure we are properly managing compliance, privacy, and security. We also need to think about risk management with systems.”
Will the interest in DCTs fade when the pandemic passes?
“If, after the pandemic, you have to go to a patient and say, ‘Well, we're going to now take this convenience away,’ that person will react viscerally. If I've been engaging with the patient in their home for the last six months, and now you're going to make them come back to the site, they're going to say, ‘Well, I don't want to participate in the trial anymore.’
“The patient's voice is going to be a critical element in making DCT a permanent solution that will ultimately be incorporated into every protocol where appropriate. The patient experience is going to be largely driven by convenience and comfort.”