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Professor of Medicine
Director, Breast Oncology and Clinical Trials Education
Division of Hematology/Oncology
Department of Medicine
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California
Hope S. Rugo, MD, has disclosed that she has received funds for research support from Amgen, Daiichi, Eisai, Genentech, Immunomedics, Lilly, MacroGenics, Merck, Novartis, OBI, Odonate, Pfizer, and Seattle Genetics and support for travel from Amgen, AstraZeneca, Daiichi, MacroGenics, Merck, Mylan, Pfizer, and Puma.
The COVID-19 pandemic has altered the way we care for our patients with breast cancer in numerous ways. One major roadblock to keeping clinical trials running has been the ability of institutions to function as a clinical trial site. When many nonessential personnel were asked to stay at home, we no longer had the human resources needed to operate trials, including clinical research coordinators, and clinical and laboratory technicians. No one was on site to obtain the tumor tissues and draw blood, nor to process samples in the lab. In addition, there were difficulties with shipping and distributing experimental agents. These challenges necessarily led to temporary closures for many clinical trials.
Meanwhile, the procedures involved in the development of new studies were immediately slowed by an inability to conduct in-person meetings. With the subsequent pivot to virtual meetings, conversations between investigators, pharmaceutical companies, and regulatory agencies eventually continued. Some trials saw an immediate drop in enrollment as patients were understandably reticent to attend in-office visits. Not only were patients hesitant to visit the medical center, particularly at the frequency that is generally required for most clinical trials, they were also avoiding visits with local oncologists, where most referrals into clinical trials occur. Hence, patients were not being referred and were hesitant to sign up for more frequent visits in a clinical trial.
At my center, we adapted to the challenges posed by COVID-19 by implementing use of electronic signatures. This allowed patients to review trial documents and provide consent electronically, and enabled investigators to create attributions and report this information to the sponsors and regulatory agencies with remote help from our clinical trial coordinators. Of interest, there have been some regulatory issues with using electronic signatures that are still unsettled; in the long term, it may be costly and more complicated to comply with the regulatory requirements.
Some trials have been able to allow telemedicine visits after the initial patient evaluations to replace clinic visits. Others have had less flexibility in terms of regulatory requirements and have opted to have patients conduct their evaluations on site. For example, some studies require ECGs to look for QT prolongation; others call for a prolonged period of observation after administration of the study drug. Clearly, patients need to be on site in these situations.
Current Status of Clinical Trials
Currently, most trials have reopened at sites that are able to safely receive patients for blood tests, scans, and other data reporting. Patient referrals are improving, and patients are less reticent to enroll, thanks in part to our community doing a great job of informing patients that the risks posed by the pandemic are very low. There is little evidence that patients are acquiring any infections at clinical trial sites, where a great deal of screening is going on and risk mitigation efforts are in place to protect both patients and staff.
Our patients have been aware since the beginning of the pandemic that by being immunocompromised, they may be at relatively higher risk for complications from COVID-19 and possibly also at higher risk for acquiring the infection. Evidence on these risks is starting to be published, and we will soon better understand the relative risks. It does appear that the risks for patients with cancer mirror those of the noncancer population and that active treatment is only one smaller component of risk.
As a broader oncology community, we must figure out how to preserve the drug development process as much as possible. That requires flexibility, including the ability to do more telemedicine visits without affecting patient safety. Moreover, we need to determine how we can open new trials, evaluate protocol amendments, and accomplish all of the steps required for clinical trials to run successfully while trial staff work from home.
To this end, we must continue to implement available technologies and respond to real-time feedback around virtual platforms. Pilot studies can be used to inform larger study design in this new landscape, and digital prospective registries can be considered in lieu of traditional, site-based trials.
It has been a challenge to work through the barriers presented by COVID-19, but I am optimistic that the end results will improve our long-term efficiency in opening and operating trials and offering new treatment options.
As a community, we have had to respond creatively to a unique and overwhelming situation affecting people worldwide. In the end, our flexibility and ingenuity will improve our processes of conducting clinical trials and will advance patient safety as well as patient care.