The COVID-19 pandemic has disrupted clinical operations and accelerated much-needed change, according to a new survey conducted by Informa Pharma Intelligence on behalf of Oracle Health Sciences. With patients unable to physically visit clinical trial sites, 76% of survey respondents noted that the pandemic sped their adoption of decentralized clinical trial methods. The same percentage (76%) reported at least some of their trials have already been decentralized, and 38% indicated more than half are decentralized. But despite this momentum, respondents said concerns remain around decentralized trial data collection and quality, as well as regulatory guidance.
In regards to ongoing clinical trials, survey respondents said COVID-19 has caused longer enrollment times (49%), amended protocols (45%), and paused protocols (41%).
“The pandemic will have a profound and lasting effect on clinical trials,” said Henry McNamara, senior vice president and general manager, Oracle Health Sciences. “The survey results illustrate how quickly the industry has pivoted and adopted new approaches, such as decentralized clinical trial methods, to keep clinical research going in these unprecedented times. Fortunately, our technology supports this change today and is designed to carry the industry forward.”
The Accelerated Evolution of Clinical Trials in a Pandemic Environment survey, which was conducted from September 21 through November 11, 2020, gathered data from 252 respondents representing professionals from biopharmaceutical companies, CROs, and medical device companies involved in the operation and management of clinical trials. The respondents were located primarily in North America and Europe, with some representation from the Asia Pacific and the rest of the world.
Decentralized Trials: Opportunities and Challenges
In moving to decentralized clinical trials, the most common steps taken by respondents are the adoption of patient-facing technologies or alternatives (64%) and protocol redesign (63%), followed by the adoption of investigator-facing technologies or alternatives (53%).
When asked about the challenges of adopting decentralized trial methods, patient care and data issues topped the list. Survey respondents cited patient monitoring and engagement (59%) as the top challenge, followed by ensuring data reliability and quality (50%) and data collection (45%).
With the shift to decentralized clinical trials comes the introduction of wearables, remote patient monitoring, and the associated need for remote data collection. According to the survey results, 67% of respondents have already implemented remote data collection into their trials, primarily through the implementation of patient apps (57%), ePRO (49%), and wearables/devices (45%).
Specifically, as it relates to wearables and remote monitoring technology, respondents’ top concerns with this shift are data requiring a different approach to review, manage, and interpret (49%), expense (46%), and complicated regulatory considerations (42%).
Additionally, respondents were universally concerned with the clinical data gathered from wearables and remote monitoring technology. The top issues noted were in regards to remote data collection, including data quality (57%), data protection/privacy (40%), and lack of standardization in data (36%).
However, these concerns were balanced with an expectation that using wearables and remote monitoring technology would increase patient convenience (64%), provide a more comprehensive supply of real-time data and insights (52%), and result in savings in terms of time and resources for site staff (45%).
“There’s no question organizations have adapted to decentralized trials very quickly, but there are many advantages and disadvantages to address,” McNamara added. “It’s clear with the right regulatory guidance, processes, and technologies in place, the shift can be advantageous to patients, sites, and sponsors moving forward. In the end, it’s really about serving the needs of the individuals participating in the trials, who are donating their time and their bodies to research for the advancement of medicine.”
Industry Divided on Regulatory Guidance
While the move to decentralize clinical trials is well underway, the survey revealed that the industry is divided regarding the clarity of current regulatory guidance surrounding decentralized trials and data collection, indicating a need for improvement. When asked if the current regulatory guidance was clear, 52% said “yes,” and 48% said “no.”
Additionally, from the 24% of respondents who reported that the pandemic had not accelerated their adoption of decentralized clinical trials, regulatory concerns (42%) were a top reason.
“With 48% of respondents indicating that current regulatory guidance surrounding decentralized trials and data collection is not clear, there is an opportunity for the industry to work with the regulators to help bring the clarity needed for sponsors to embrace this emerging model,” noted McNamara.