A group of researchers from multinational contract research organization (CRO) IQVIA and the Cancer Research Institute studied COVID-19-related delays of major clinical trials around the world. The impact has been deep and severe. With a focus on oncology research—in many cases, impacting life and death for those severely ill with forms of cancer—over 200 cancer-based clinical trials were suspended between March and April based on surveys and a review of Clincialtrials.gov. For existing studies, enrollment rates have slowed due to pandemic related issues such as lockdowns, safety concerns, research staff shortages as well as potential risks associated with type of cancer treatment and route of administration.
The Research was led by CRO IQVIA and the Cancer Research Institute during the period of March 23, to April 3, 2020. The pair surveyed 36 investigators involved with oncology studies at centers around the world. IQVIA by itself studied a subset of 200 of the CRO’s oncology trials in a bid to identify significant risks impacting the studies. The study was published in Nature Reviews Drug Discovery.
Major Impacts to Cancer Trials
Especially in the United States and Europe, the Pandemic hammered the clinical trials sector: Only 20% of sponsors in the U.S. and 14% in Europe continued to enroll patients at the usual rates. For those that continued to enroll with lower enrollment rates, patient care represented a key factor with 9 out of 13 respondents suggesting it as one of the top considerations triggering challenges in ongoing patient enrollment.
Certain cancer therapies involving route of administration represented a key consideration as did concerns about patient safety and the possibility of lack of key research staff and other resources. Investigators suggested in interviews that risk-benefit analysis centering on patients in ongoing trials was high on the mind of whether to proceed, regardless of design or complexity of trial.
As COVID-19-related public health crisis expanded, regulatory and operational challenges rapidly grew as patients ill from the novel coronavirus in some regions overwhelmed medical infrastructures. Nearly 60% of investigators reported that the pandemic had moderate to high impact triggering delays or cancelled patient visits—nearly 80% of the surveyed investigators anticipated protocol deviations would trigger unresolved queries.
The COVID-19 pandemic has severely impacted most facets of life, and clinical research is no exception. The implications of the suspensions, delays or slowdown represent material health, business and financial impact ongoing. The IQVIA and Cancer Research Institute sponsored study is an attempt to begin to assess the quantitative and qualitative impacts.
Samik Upadhaya, PhD Cancer Research Institute
Jia Xin Yu, PhD, Cancer Research Institute
Cristina Oliva, VP of Oncology, Head of Oncology Center of Excellence, IQVIA
Megan Hooton, VP Global Head Oncology Project Leadership, IQVIA
Jeffrey Hodge, VP Development Solution, Oncology Center of Excellence
Venessa M. Hubbard-Lucey, PhD, Cancer Research Institute
Anna-Maria Kellen, Clinical Accelerator, Cancer Research Institute
Call to Action: Read the study results.