“Decentralized clinical trials” is the new buzz phrase in the clinical research community. The advancement of decentralized trials has been accelerated due to the pandemic and the need to do more remotely.
For those who aren’t aware, decentralized trials are intended to be conducted completely virtually with the subject not having to ever go to the clinic. Since it’s rare when clinical trials can be operated completely remotely, the term is also applied to hybrid clinical trials where some of the assessments and procedures are in person at the clinical trial site and some things are done remotely. The primary goal of decentralized / hybrid trials is to remove barriers and make participation in clinical trials easier for research participants.
As this new era dawns in clinical research, we need to exercise caution before diving headfirst.
I believe that fully decentralized or partially decentralized trials are extremely important to the future of clinical research. They have immense potential to be used effectively to accelerate the testing of new medications. I see this to be particularly true for rare disease studies that can be extremely challenging to conduct. Imagine, all those studies we’ve wanted to do, but couldn’t because recruitment is so difficult.
I’ve been working for a large clinical site network for 27 years. I’ve had the pleasure of attending several advisory panels and consulting with a few companies to provide feedback on decentralized trials from a site’s perspective.
During these workshops / advisory meetings, I’ve observed a few things:
- One of the purposes of these workshops appears to be an effort to convince clinical trial sites about the merits of decentralized trials. The hosts of the meeting seem to prioritize this objective over gathering valuable feedback from sites who have conducted these studies.
- The hosts seem surprised when issues are raised that may present obstacles to conducting decentralized trials.
- There is constant reassurance that the sponsor/CRO has thoroughly vetted the technology or the vendors and that issues raised wouldn’t be issues for their studies.
The reality for sites who have done these studies is that there are several challenges that have not been adequately addressed to date:
- Investigator oversight. The Principal Investigator is fully responsible for the conduct of the study for the site. Any personnel assessing or conducting procedures for a participant must be vetted by and answer to the Principal Investigator. Nursing agencies that conduct home visits that are contracted by the sponsor or CRO currently do not permit adequate oversight by the PI. The PI cannot rely on the sponsor or CRO’s assertion that the training of the employee of the nursing agency has been adequate. Simply passing a GCP quiz is not sufficient training for clinical trials. If that individual makes an error, the Principal Investigator is responsible from a regulatory perspective and a medical legal perspective.
- Patient contact. Patients who are seen in person develop a connection with their medical professionals that is difficult to establish remotely. As a result of in person interactions, valuable information is collected about the participant that relates to the clinical trial. As just one example, during an in person visit by well trained staff, an Adverse Event may be discovered during a casual conversation while the participant is waiting for procedures that wasn’t disclosed when prompted earlier.
- Expertise. One of the great benefits of clinical research is the experience that investigators gain about the drug and indication being researched by seeing, directly assessing and interacting with patients. Those interactions can’t be replicated virtually to the same degree.
- Expertise part II. A decentralized clinical trial usually means sites are paid less per subject in a clinical trial. Margins for clinical trial sites are already very low and shrinking every year as more is added to their responsibilities for the same or less reimbursement. The clinical trials industry will lose key opinion leaders and disease experts if their sites do not receive adequate funding for decentralized trials.
- Technology. Technology for decentralized clinical trials is far from being optimized and currently increases workload for clinical trial sites instead of making their jobs easier.
I’m excited about the potential for decentralized clinical trials (both fully and partially decentralized) to accelerate drug development. However, the technology, processes and concepts need more input from the clinical research sites who conduct the trials. Their concerns and objections need to be heard or we will not fully realize the potential for decentralized trials.
I welcome feedback on this article so that we can work together to make well designed and conducted decentralized trials a reality.
Ted Trafford
Clinical Research 
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