From: Cancer Research Institute
- Results of recent survey of clinical trial investigators in United States, Europe, and Asia together with analysis of ongoing clinical trials conducted by IQVIA published in Nature Reviews Drug Discovery
- COVID-19 has significantly impacted patient enrollment in oncology clinical trials in U.S. and Europe with less effect in Asia at time of the survey
- Clinical trial investigators reported therapy type or route of administration was a top consideration for trial enrollment; 73% were avoiding or planning to avoid immunosuppressive treatment regimens and 64% were shipping or planning to ship oral drugs directly to patients’ homes
The Cancer Research Institute (CRI) and IQVIA™ (NYSE:IQV) have published new findings in Nature Reviews Drug Discovery on the current challenges, risks, and contingencies for global oncology trial management amid the COVID-19 pandemic. The study adds to the growing analysis of COVID-19’s impact on R&D activities, and the downstream effect on new or improved treatments.
Between March 17 and April 3, 2020, CRI and IQVIA surveyed 36 clinical investigators in the United States, Europe, and Asia to better understand the disruption of clinical activities, specifically in oncology trials. The survey information was augmented with telephone interviews with 16 key opinion leaders and IQVIA data analysis on more than 200 ongoing oncology trials.
The results showed that patient enrollment in oncology clinical trials was significantly impacted, especially in the United States and Europe, where 60% and 86% of institutions, respectively, were enrolling new patients at a lower rate. Barriers to enrollment include access (especially for inpatient care), investigator concern about patient safety, potential lack of research staff, and cancer treatment type/route of administration (e.g., intravenous drugs that cannot be taken at home).
“Our goal with this analysis was to provide an initial assessment of the impact of the COVID-19 pandemic on the current landscape of global clinical trials in oncology and the implications for investigators and patients,” said Vanessa Hubbard-Lucey, Ph.D., M.B.A, director of the CRI Anna-Maria Kellen Clinical Accelerator and Venture Fund and co-author of the paper.
“In collaborating with CRI, we have a comprehensive understanding of the risks to trial conduct, enabling IQVIA to deploy creative solutions to minimize the impact to oncology trials today and in the future,” added co-author Megan Hooton, vice president and head of Oncology Global Project Leadership at IQVIA.
Additional key findings are as follows:
- Nearly 60% of investigator reported that COVID-19 had a “moderate” or “high” impact in delaying or canceling patient visits.
- Investigators were considering remote technologies and strategies to assess patients including telemedicine (82%) and alternative locations for assessments (73%)
- Investigators in China said the clinical research infrastructure has either already returned to pre-pandemic levels or was expected to return to full functionality by the end of April. In contrast, U.S. investigators expected at least three to six months before clinical research programs could be fully operational again.
The greatest operational risk of the pandemic was predicted to be study milestones including delays to activation of sites, enrollment and data collection and cleaning, as identified through the analysis of 200 ongoing trials, a subset of IQVIA-managed oncology trials.
“We recognize the COVID-19 pandemic will have an enduring impact on the way oncology trials are conducted in the future,” said Hooton. “Approaches such as digital patient recruitment, telemedicine, and remote monitoring can ensure patient safety and access to clinical trials whilst maintaining integrity of the trial and may be adopted with increasing frequency after this global crisis has resolved.”
Analysis of operational data on this subset of trials has continued, with early indicators such as site activation and patient enrollment metrics presenting a reality that may be less severe than originally anticipated. These updated analyses, together with a planned expansion of investigator surveys will help CRI and IQVIA provide greater insight into the impact of the pandemic and approaches for future mitigation.
To access an interactive dashboard of the report, visit the CRI website at cancerresearch.org/covid-cancer-trials.
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Upadhaya S, Yu JX, Oliva C, Hooton M, Hodge J, Hubbard-Lucey VM. Impact of COVID-19 on oncology clinical trials. Nat Rev. Drug Discov. https://www.nature.com/articles/d41573-020-00093-1
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