Disruption, Decentralized Clinical Trials and the Regulatory Impact of COVID-19

The global pandemic COVID-19 has incited the world, and the clinical trial industry, to change.

The COVID-19 pandemic has sadly killed millions of people worldwide, having spread to over 228 countries. The US has been impacted heavily, as it has the highest official case count (having surpassed 14 million confirmed cases) and has recorded the highest number of fatalities (more than 276,000).

Companies and researchers are actively conducting clinical trials to prove the safety and efficacy of COVID-19 vaccines. Since April 6^th COVID-19 clinical trials have increased by 585%.

Currently, there are over 3,800 clinical trials testing against COVID-19. While the majority of the trials are in Phase II or higher (e.g., II/III,  III, III/IV, IV), there are still nearly a thousand (919) trials facilitated in Phases 0, I, and I/II. The FDA has already approved several vaccines, from Pfizer, Moderna, Johnson and Johnson to name a few.

One thing that has been unique about the current clinical trial landscape – both for COVID-19 studies and other therapeutic areas, has been the increasing adoption of decentralized clinical trial techniques. While decentralized clinical trial technology was being explored pre-pandemic, these tools for site operations and patient engagement have been crucial to keeping clinical trials operational despite the challenges of the global pandemic. Thankfully, the swift action taken by regulatory agencies such as the FDA and EMA issued guidance to permitted sites, sponsors and CROs to adjust their study operations to meet changing conditions for clinical trials and implement new solutions to do so.

Decentralized Clinical Trials: Here To Stay

The industry will likely remain in a state of disruption for the foreseeable future. In a recent webinar conducted by GlobalData, attendees were polled on the future of Decentralized Clinical Trials (DCT). The majority (57%) of respondents expect DCTs to be frequently used in the next 1-2 years. As recently published by my colleague Zach Hales, we at Greenphire believe that the momentum towards adopting technology to facilitate clinical trial flexibility is here to stay.

DCTs offer numerous benefits and, as polled by those on the webinar, includes greater participation by patients in clinical trials (17%), increased participation by sites in trials (16%), allows trials to run during COVID-19 (14%), etc. Respondents who have both used and not used DCTs considered the reduction of trial cost and trial timeline to be beneficial.

Challenges for Remote Trial Execution

With the idea of transitioning to more DCTs, comes the obstacles that would impact such, those highlighted by respondents were: Changes required to procedures, processed and/or systems (21%), unclear regulatory acceptance (16%), the ability of investigators to perform their regulatory duty (11%).

In addition, respondents were also polled as to the biggest changes needed to pivot to DCTs. Of the responses, the following received the most responses: System integrations and alignment (17%), process changes and alignment (16%), Training (16%), Regulatory/operational risks (15%). The similarity and proximity in responses show that there are many perceived changes that need to be made to transition to DCTs.

Best Practices & Observations for Decentralized Trial Conduct

Given our experience delivering clinical trial services over the past year, I wanted to weigh in on what we have seen as shifts that have taken place because of COVID-19. The dramatic increase in adoption of our patient and site-focused technologies shows that sponsors, CROs and sites are committed to implementing solutions to keep studies going. Training and documentation on new systems and procedures are crucial not just for adoption, but also for compliance.

Also, we have seen massive growth in remote audits. In previous years they were generally used for brief, less-critical inspections. However, now things have gone completely virtual, which inherently induced process change/improvement as a direct effect, then in cascading fashion compliance with training/preparation.

Helpful Resources on Regulation and QA:

Given how much has changed over the past year, I wanted to bring together various resources:

• FDA: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fda-guidance-conduct-clinical-trials-medical-products-during-covid-19-public-health-emergency
• https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-10/guidanceclinicaltrials_covid19_en.pdf
• https://greenphire.scorrinteractive.com/covid-19-clinical-trial-regulatory-guidelines-6-steps-the-industry-can-take-to-support-the-needs-of-patients-and-sites/
• https://greenphire.scorrinteractive.com/fda-guidance-qa-on-clinical-trial-operations-amidst-covid-19/