- 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
NEW YORK and DANBURY, Conn., May 18, 2020 – 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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About the Cancer Research Institute
The Cancer Research Institute (CRI), established in 1953, is the world’s leading nonprofit organization dedicated exclusively to saving more lives by fueling the discovery and development of powerful immunotherapies for all types of cancer. Guided by a world-renowned Scientific Advisory Council that includes four Nobel laureates and 26 members of the National Academy of Sciences, CRI has invested $420 million in support of research conducted by immunologists and tumor immunologists at the world’s leading medical centers and universities, and has contributed to many of the key scientific advances that demonstrate the potential for immunotherapy to change the face of cancer treatment. To learn more, go to cancerresearch.org.
About the CRI Anna-Maria Kellen Clinical Accelerator
CRI’s clinical program, the Anna-Maria Kellen Clinical Accelerator, is a unique academia-nonprofit-industry collaboration model that serves as an “incubator” that delivers multi-center clinical trials for promising new immunotherapy combinations. CRI’s venture philanthropy fund supports clinical trials within this program, which fosters a collaborative environment that enables scientists to advance their most ambitious research ideas and accelerates studies that one group or company could not do alone. To learn more about the Anna-Maria Kellen Clinical Accelerator, go to cancerresearch.org/clinical-accelerator.
IQVIA (NYSE:IQV) is a leading global provider of advanced analytics, technology solutions and contract research services to the life sciences industry. Formed through the merger of IMS Health and Quintiles, IQVIA applies human data science — leveraging the analytic rigor and clarity of data science to the ever-expanding scope of human science — to enable companies to reimagine and develop new approaches to clinical development and commercialization, speed innovation and accelerate improvements in healthcare outcomes. Powered by the IQVIA CORE™, IQVIA delivers unique and actionable insights at the intersection of large-scale analytics, transformative technology and extensive domain expertise, as well as execution capabilities. With approximately 67,000 employees, IQVIA conducts operations in more than 100 countries.
IQVIA is a global leader in protecting individual patient privacy. The company uses a wide variety of privacy-enhancing technologies and safeguards to protect individual privacy while generating and analyzing information on a scale that helps healthcare stakeholders identify disease patterns and correlate with the precise treatment path and therapy needed for better outcomes. IQVIA’s insights and execution capabilities help biotech, medical device and pharmaceutical companies, medical researchers, government agencies, payers and other healthcare stakeholders tap into a deeper understanding of diseases, human behaviors and scientific advances, in an effort to advance their path toward cures. To learn more, visit www.iqvia.com.
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