In an article published in Nature Reviews Drug Discovery, researchers discussed the current challenges, risks, and future implications for global oncology trial management as a result of the coronavirus disease 2019 (COVID-19) pandemic.1
“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,” co-author Vanessa Hubbard-Lucey, PhD, MBA, director of the CRI Anna-Maria Kellen Clinical Accelerator and Venture Fund, said in a press release.2
The Cancer Research Institute (CRI) in partnership with IQVIA surveyed a group of 36 investigators who are conducting clinical trials in the cancer space at institutions around the world. Additionally, IQVIA conducted an internal analysis of a subset of its own oncology trials (n > 200) to identify the major risks affecting their trials.
The results demonstrated that patient enrollment in oncology clinical trials was significantly affected, especially in the US and Europe, where only 20% and 14% of the institutions, respectively, were continuing to enroll patients at the usual rate.
Moreover, for those that were engaged in trials that were continuing during the pandemic, but with lower enrollment rates, patient care was deemed a key factor, with 9 out of 13 respondents listing it as one of the top 3 considerations causing the most difficulty in patient enrollment in ongoing trials. The type of cancer care, including route of administration, was another key consideration.
With consideration for starting new trials, similar trends were observed in the survey responses, with patient care, cancer therapy type, and route of administration at the top of the list of consideration. In follow-up interviews, therapies which required intravenous administration also concerned the majority of investigators, as oral therapies could more easily be shipped to patients’ homes for self-administration.
As medical infrastructure was overwhelmed by cases of COVID-19, the researchers looked to evaluate how investigators were dealing with new regulatory and operational obstacles. Overall, nearly 60% of investigators reported that the COVID-19 pandemic had a “moderate” or “high” on patient visits. Even further, the majority of respondents reportedly expected protocol deviations would cause unresolved queries, such as incomplete patient visit data.
Notably, the separate analysis of IQVIA-run oncology clinical trials found milestone delays to be the most commonly reported risk due to the pandemic. The researchers suggested that these predicted delays will most likely be caused by delays to site activation, enrollment, patient visits, and/or data collection and cleaning.
“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,” co-author Megan Hooton, vice president and head of Oncology Global Project Leadership at IQVIA, said in a press release.
Investigators in China indicated that the clinical research infrastructure has either already returned to pre-pandemic levels or was expected to return to fully functional by the end of April. Contrastingly, US investigators anticipated it would be at least 3 to 6 months before clinical research programs could be fully operational again. Some European investigators would not even predict timelines, as many regions were still seeing a rise in positive cases.
“We recognize the COVID-19 pandemic will have an enduring impact on the way oncology trials are conducted in the future,” explained 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.”
Looking to the future, interviews highlighted the possibility that the COVID-19 pandemic could have a lasting impact on clinical research and the practice of medicine moving forward, with new approaches such as telemedicine possibly being adopted with increased frequency.
Researchers indicated that future surveys including an increased number of investigators and regions, as well as updated analyses of operational performance metrics, are necessary to provide greater insight into the impact of the pandemic and possible solutions for mitigating its impact on clinical trials.
1. Upadhaya S, Yu JX, Oliva C, Hooton M, Hodge J, Hubbard-Lucey VM. Impact of COVID-19 on oncology clinical trials. Nature Reviews Drug Discovery. doi:10.1038/d41573-020-00093-1.
2. Cancer Research Institute and IQVIA Uncover the Impact of COVID-19 Pandemic on Global Oncology Clinical Trials [news release]. New York and Danbury, Connecticut. Published May 18, 2020. cancerresearch.org/news/2020/cri-iqvia-covid-19-oncology-clinical-trials. Accessed May 19, 2020.