Harpreet Singh, MD, is director of Division of Oncology 2 at the U.S. Food and Drug Administration (FDA). In the following interview, she discusses the FDA’s response to the COVID-19 pandemic in how clinical trials are conducted, as well as the implications of these changes and what can be expected going forward.
Q: How has the FDA responded to the need to modify clinical trial conduct during the COVID-19 pandemic to keep patients safe?
A: The clinical trial ecosystem experienced dramatic changes since the onset of this public health emergency. We recognized early in the course of the pandemic that trials needed to quickly adapt, and we responded with a COVID-19 Clinical Trials Guidance1 for investigators and sponsors.
Patient safety is at the center of our efforts. The goal of trials is to maximize patient safety while maintaining trial integrity, and this remains the case during the COVID-19 pandemic. Our focus is on the safe delivery of investigational products to patients with cancer.
We were able to publish guidance to industry on COVID-19–related issues in a matter of weeks, as compared to what typically can take months to years, and we have been continually communicating with the clinical trial community. The guidance has been updated several times to convey the FDA’s current thinking and to respond to frequently asked questions. Our hope is that this, in part, contributes to patients’ ability to continue treatment on clinical trials in the safest way possible.
Q: If telehealth is being incorporated into trials, how is this being handled?
A: The FDA quickly recognized that changes in protocol conduct may be necessary to ensure patient safety. This includes conducting telephone or video contact visits, rather than on-site visits, for safety monitoring. These changes could be immediately implemented, with subsequent review by the Institutional Review Board and notification to the FDA.
Because these changes may reflect protocol deviations (until the amendment is approved), the FDA asks that these changes be well documented. It should be noted that we are expecting an increased rate of protocol deviations in the COVID-19 era.
The FDA is very interested in learning from the increased uptake of telehealth from patients, investigators, and clinical trial sponsors.
Q: Are changes sponsors made to clinical trials during the COVID-19 pandemic likely to continue post COVID-19 urgency?
A: We are working to maximize the opportunity that this public health crisis has given us to identify the strengths and limitations of trial modifications, such as remote assessments, digital health, and other components of decentralized trials. The Oncology Center of Excellence (OCE) is proactively contacting major pharmaceutical companies to ask them what their common changes have been in cancer clinical trials, and how they are flagging their datasets for COVID-19–related modifications and outcomes.
We know that we will likely see some variability in the data, increased missing assessments, and likely more censoring due to the morbidity and mortality of COVID-19.
We are actively studying the effects of this pandemic on clinical trial conduct. It is important to note that the trials are here to serve the patient. The OCE has long advocated for a patient-centric approach to clinical trial conduct. So yes, I think you will see a much needed assessment of what flexibilities from the COVID-19 era can be effectively and safely carried forward after the pandemic ends.
Q: What do you want patients with lung cancer to know during this time?
A: Although our nation’s emphasis is on the need to combat COVID-19, patients with cancer and their unique needs continue to be a top priority for the FDA.
During this challenging time, we want to let patients know that we are here for them. The OCE is pushing forward. We haven’t lost our momentum or our dedication to patients with cancer.
In May 2020, the OCE approved seven oncology indications for the treatment of lung cancer, including two new oral drugs for patients with rare mutations. Both of these drugs were approved more than 3 months ahead of schedule.
Although clinical trial enrollment overall has declined, it is our hope that FDA guidance provides sponsors and investigators with a clear path to re-initiating trials in which appropriate safety measures can be implemented. While some trials halted enrollment at the start of the pandemic, we are now seeing them able to safely reopen. It is imperative that we continue the immense progress that has been made in lung cancer, which has been made possible through patient participation in clinical trials.
Reference:
1. FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency. U.S. Food and Drug Administration. Published March 2020. Accessed July 31, 2020. https://www.fda.gov/regulatory-information/search-fda-guidance-document….
