‘Snapback’ to Pre-Pandemic Trial Approaches Unlikely, Focus Is on Innovation
As the return to normalcy continues in the post-COVID-19 pandemic world, a new state of the industry report shows that most sponsors and CROs intend to continue using innovative measures adopted during the health crisis and believe such approaches are here to stay.
The report, based on a survey by WCG’s Avoca Group, showed that decentralized trial and patient engagement innovations, for example, had already seen interest or increased use prior to the health crisis, but responses varied widely depending on the type of innovation. Most surveyed believed that adapting to the pandemic had had a positive effect on clinical research and trial quality.
“There was very widespread agreement that the pandemic had been critically impactful or very impactful in actually improving the research model in a sustainable way for the whole industry,” said Denise Calaprice, a senior consultant at WCG Avoca. “For every innovation, every category of innovation and every aspect of quality we asked about, most people felt that the impacts on quality had actually been positive rather than compromised. Interestingly, even though implementation was lowest and there was concern about lack of understanding it, some of the most positive perceptions were use of artificial intelligence (AI) in protocol and clinical development and design planning.”
According to those who responded, the innovations most likely to have been picked up in response to COVID-19 included shipping clinical supplies to patients’ homes (47 percent), conducting study visits by telemedicine (40 percent) or home healthcare providers (32 percent) and hybrid trials (33 percent).
Conversely, a number of innovations were found to have been already adopted or eyed with interest before the pandemic hit, including electronic patient diaries (76 percent), online patient communities (58 percent) and the use of wearable sensors (57 percent). Ninety-four percent said they had already adopted or intended to incorporate visits via telemedicine into the trials, while 49 percent said they had no plans to work toward conducting completely site-less trials.
Most respondents, asked what they thought about the impact of such innovations on trial quality, believed decentralized activities would help retain and diversify study participants and support the streamlining of clinical development programs. Around one-quarter felt that decentralization could create significant risks to protocol compliance, participant safety and participant privacy.
A number of data/risk management and monitoring innovations had begun seeing use prior to the pandemic, including risk-based monitoring and study management tools (70 percent) and centralized remote monitoring (50 percent). But a number of tools were adopted by companies in large part due to pandemic restrictions, including remote reviews of source data (45 percent), remote verification of source data (41 percent) and remote reviews of electronic investigator site files (40 percent).
Of the respondents, nearly all — 97 percent — had adopted or planned to adopt remote reviews of source data, but 58 percent said they had no intentions of leveraging AI to detect possible unreported adverse events, the survey found. Most respondents felt that innovations in the category aided data completeness and accuracy, protocol compliance, study data interpretations and participant safety, although more than 15 percent of them raised concerns about risks to participant privacy and the amount of human and financial resources that could be necessary.
Innovations in those two categories were the most likely to have seen use in response to COVID-19. On the other hand, innovative use of AI was spurred only on a small scale by the pandemic, with zero to 20 percent reporting they adopted certain AI-based innovations because of the crisis. Despite the relatively low adoption rates, most of those surveyed felt that such technology had a largely positive impact on trial quality, viewing the category as benefiting data completeness and accuracy, data interpretation, protocol compliance, the streamlining of clinical development programs, and the retention and diversity of participants. By comparison, only a few respondents felt the technology posed significant risks to trial quality.
The use of nontraditional study designs and endpoints were also only adopted on a small scale during the pandemic, with only 5 percent to 15 percent taking up such approaches. Around half of the respondents felt the innovations had a neutral impact on most trial quality aspects, while most of the remainder felt they had a positive effect. Thirty-two percent of respondents, however, felt that nontraditional study designs and endpoints could negatively impact the ability to interpret study data.
All respondents, including ones whose companies had not begun using nontraditional study designs and endpoints, cited regulatory concerns as the primary barrier toward effectively bringing on board such innovations, the report said.
Read the full report here: https://bit.ly/3cRtaOi.