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ASCO: COVID-19 Will Have Long-Term Effects on Clinical Trials
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The coronavirus disease 2019 (COVID-19) pandemic has had a profound impact on not only clinical care but also research and development. Survey after survey predicts likely long-term implications for pharmaceutical research and development and specifically oncology clinical trials.
A survey by the American Society of Clinical Oncology (ASCO) of 32 investigators early in the COVID-19 pandemic found that institutions were delaying clinical research activities. Nearly 60% of respondents’ programs had halted screening and/or enrollment and ceased research-only visits except those providing cancer treatment. Additionally, 90.0% had implemented remote patient care, and 87.5% had implemented telehealth visits.1
During the early part of the pandemic, more than half of programs reported prioritized enrollment, implementing various strategies to ensure adequate patients were in trials. These strategies included a tier-based approach based on patients’ needs, safety, and disease severity; potential patient and site burdens; and availability and allocation of program resources.
A recent paper published in Nature Reviews Drug Discovery found 40% of institutions in the United States are still enrolling patients in oncology clinical trials, but half of those are doing so at a lower rate.2 Thirty-six US-based investigators interviewed for this survey said clinical research programs would not be fully operational for 3 to 6 months. Nearly 60% of investigators reported that COVID-19 had a moderate or high impact on delaying or canceling patient visits. Investigators acknowledged that this was a small survey, but that it indicates the effect that COVID-19 has had on cancer research.
The survey included a separate analysis of IQVIA-run oncology clinical trials and found that milestone delays were the most common risk due to the pandemic. Additional analysis of data from ClinicalTrials.gov indicates that more than 200 interventional oncology studies were suspended in March and April 2020 because of COVID-19.
“We recognize the COVID-19 pandemic will have an enduring impact on the way oncology trials are conducted in the future,” Vanessa Hubbard-Lucey, PhD, MBA, director of the Cancer Research Institute’s Anna-Maria Kellen Clinical Accelerator and Venture Fund and coauthor of the Nature Reviews Drug Discovery paper, said in a press release. “Approaches such as digital patient recruitment, telemedicine, and remote monitoring can ensure patient safety and access to clinical trials [while] maintaining integrity of the trial and may be adopted with increasing frequency after this global crisis has resolved.”3
According to the ASCO survey, challenges for continuing clinical trials during the COVID-19 pandemic included reluctance of patients to go for office visits and limited availability of services such as radiology and surgery. Respondents also said staff spent additional time organizing and implementing telehealth, as well as working with sponsors and independent review boards to modify trials.
Analysts at McKinsey & Company found sponsors worked hard to limit the disruptions to trials for oncology and rare diseases, whereas other areas such as gastrointestinal, infectious, and respiratory diseases and vaccines experienced significant disruption.4 Research and development leaders said they are spending 40% to 50% of their time on crisis management, resulting in declines in productivity.
These reports suggest clinical trials post COVID-19 will likely continue with many of the changes that have been implemented during the pandemic, all of which afford more focus on the patient and site. Limiting of in-person visits through telehealth and remote assessments could continue. Additionally, ASCO suggests that trials in the future could have expanded or flexible timelines and reduced data collection requirements, and e-signatures for trial documents should become standard practice.
References
1. Waterhouse D, Harvey RD, Hurley P, et al. Early impact of COVID-19 on the conduct of oncology clinical trials and long-term opportunities for transformation: findings from an American Society of Clinical Oncology survey. JCO Oncol Pract. 2020;16(7):417-421. doi:10.1200/OP.20.00275
2. Upadhaya S, Yu JX, Olivia C, Hooton M, Hodge J, Hubbard-Lucey VM. Impact of COVID-19 on oncology clinical trials. Nat Rev Drug Discov. 2020;19(6):376-377. doi:10.1038/d41573-020-00093-1
3. Cancer Research Institute and IQVIA uncover impact of COVID-19 pandemic on global oncology clinical trials. News release. Cancer Research Institute. May 18, 2020. Accessed July 6, 2020. bit.ly/2DiNHwh
4. Agrawal G, Parry B, Suresh B, Westra A. COVID-19 implications for life sciences R&D: recovery and the next normal. McKinsey & Co. May 13, 2020. Accessed July 6, 2020. mck.co/31Q7w84
