The present-day disruptions of the coronavirus pandemic on the clinical research enterprise can and will be addressed by stakeholders in ways that should deliver long-term benefits to both clinical trial participants and practitioners, representatives from several trial service providers indicated in recent webinars.
In a late-May presentation on “The Impact of COVID-19 on Clinical Trial Conduct: The Importance of Considering Patient Stress, Coping, and Perceptions,” Tools4Patient Vice President for Business Development Erika Smith, PhD, said, “In order to understand the impact of the COVID-19 pandemic on trial data, we must understand the impact on the patient. It makes sense that patient reactions to COVID-19 will vary depending on their personalities.” The company is a technology provider focused on improving clinical data by reducing its variability.
In these pandemic conditions, many worried patients have dropped out of trials while continuing patients are experiencing additional stresses, Smith said. Increasing data variability will result from the combined effects on study participants of remote visits and outcome assessments, experiences with fear and stress, differing expectations/needs/hopes for the efficacy of their treatment, and the social isolation and decrease in social support they may be undergoing, she added.
“Trials have historically considered biological outcomes, while [we believe an] understanding of the psychology of the individual patient will help researchers understand the outcomes,” Smith explained.
Built on what the company is learning from current conditions, Tools4Patient’s COV·IQ approach aims to understand how a response to a crisis is unique to an individual trial patient, based on his or her personality, perceptions, and beliefs. “The approach will have to be customized to each trial,” Smith noted.
During another webinar in May, this one sponsored by PharmaVoice and focused on “Transitioning Clinical Studies from Traditional to Decentralized: An Operational and Regulatory Perspective,” presenters from Parexel looked at some of the pandemic’s recent and probable effects on the conduct and regulation of decentralized clinical trials (DCTs).
Fifty-two percent of webinar attendees responding to a live poll indicated they now have “greater interest” in DCTs due to the pandemic, 15% said they are “more likely to use the concept” now, and 14% each said they are either “already transitioning ongoing studies to a DCT model” or “plan to incorporate/are incorporating the DCT model into news studies.” Only 5% of respondents said the pandemic has had “no impact” on their views toward DCTs.
DCTs are designed to enhance patient access to clinical research by taking all or part of the study to them in their homes, said Rosamund Round, vice president for the Innovation Center at Paraxel. “What we’ve seen is [that regulatory acceptance of DCTs and telehealth practices] is really changing at such a fast pace during the COVID-19 pandemic,” she added. Country- and region-specific acceptance of DCTs may vary, but is swiftly evolving during the pandemic, Round said.
In evaluating a study’s suitability for being transitioned to a DCT model, Round said Parexel collaborates with sponsors to assess key study and protocol considerations that include patient profile and safety factors, patient and site burdens and challenges, methods for assessment of outcomes, vendor availability and capabilities, the investigational medicinal product’s requirements, and the study status.
In another poll conducted during the webinar, 57% of respondents “agreed” and 38% “strongly agreed” that DCT practices during the pandemic will drive long-term change toward greater acceptance of DCTs.
“It will be harder to go back to the older way of doing things once everyone’s seen and become more comfortable with” how DCTs are run, Round said.
Author: Gary Cramer