By Clinical Research News Staff

November 19, 2020 | A new survey shows that COVID-19 has slowed enrollment, driven changes to protocols, and even paused clinical research. As a result of these issues, many companies are rushing to adopt decentralized clinical trial methods.

The Accelerated Evolution of Clinical Trials in a Pandemic Environment survey was conducted from September 21 through November 11, 2020, by Informa Pharma Intelligence and sponsored by Oracle Health Sciences. Two hundred fifty-two respondents from biopharmaceutical companies, CROs, and medical device companies involved in the operation and management of clinical trials contributed data. Representatives from small and mid-sized biopharma companies make up the bulk of the contributors, and half of them worked in clinical operations. The respondents were located primarily in North America and Europe. Less than 10% were based in Asia Pacific or the rest of the world. 

Ongoing clinical trials have suffered in this season. With patients often unable to visit clinical trial sites, survey respondents said COVID-19 has caused longer enrollment times (49%), amended protocols (45%), and even paused protocols (41%). Patients have dropped out of studies (29%), IRB reviews have been delayed (27%), and data collection has not been conducted according to protocols.

As a result, three-quarters of survey respondents said that the pandemic sped their adoption of decentralized clinical trial methods. Companies have adopted patient-facing technologies or alternatives (64%), redesigned protocols (63%), and adopted investigator-facing technologies or alternatives (53%), and even launched new partnerships (32%). Seventy-six percent reported at least some of their trials have already been decentralized, and 38% indicated more than half are decentralized. 

“There’s no question organizations have adapted to decentralized trials very quickly, but there are many advantages and disadvantages to address,” said Henry McNamara, senior vice president and general manager at Oracle Health Sciences, in a statement. “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.”

Despite the current momentum, respondents remain concerned about decentralized trial data collection and quality, as well as regulatory guidance. Survey respondents cited patient monitoring and engagement (59%) as the top challenge, followed by ensuring data reliability and quality (50%) and data collection (45%). 

Data collection and patient monitoring can be facilitated with wearables, apps, and electronic patient reporting tools. Nearly 70% 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%). 

But managing and interpreting these data types still present issues. Survey-takers expressed concern about different approaches to reviewing, managing, and interpreting data (50%), the costs associated with new data streams (46%), and complicated regulatory considerations (41%). They worried about data quality (39%), data protection/privacy (39%), and lack of standardization in data (34%). 

More than half of the respondents expressed concern about ensuring compliance in a more decentralized environment. They also emphasized the need to effectively track all the data and integrate with other platforms.

Regulatory compliance is an area of particular concern. When asked if the current regulatory guidance was clear, 52% said “yes,” and 48% said “no.” And for the one quarter of respondents who reported that the pandemic had not accelerated their adoption of decentralized clinical trials, regulatory concerns (42%) were a top reason. 

But Oracle recommended viewing that disparity as an opportunity.

“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.