Many of the changes to cancer clinical trials forced through by the COVID-19 pandemic should remain, as they have made trials “more patient centered and efficient,” according to a group of thought leaders in oncology.
Among the potential improvements were more efficient study enrollment through secure electronic platforms, direct shipment of oral drugs to patients, remote assessment of adverse events, and streamlined data collection.
These changes should be implemented on a permanent basis, the group argues in a commentary published online July 21 in Cancer Discovery, a journal of the American Association for Cancer Research (AACR).
“The ability to distribute oral investigational drugs by mail to patients at their home has probably been the single most impactful change to clinical trial conduct, linked with virtual visits with patients to assess side effects and symptoms,” commented lead author Keith Flaherty, MD, who is director of clinical research at Massachusetts General Hospital, a professor at Harvard Medical School, Boston, and a member of the AACR Board of Directors.
“This has made it more feasible for patients for whom participation in clinical trials poses a disruption of their ability to work or provide care for family members to participate in trials,” he added in a press statement issued by the AACR.
Pandemic Halted Many Clinical Trials
A survey of cancer programs in early 2020 showed that nearly 60% halted screening and/or enrollment for at least some trials because of COVID-19.
“In the spring of 2020, clinical trial conduct halted and then restarted focusing on the bare minimum procedures that first allowed patients continued access to their experimental therapies, and then allowed clinical trial sites and sponsors to collect information on the effects of the therapies,” say the authors.
“The COVID-19–induced changes to clinical trials were a big challenge, probably the largest change in clinical trial conduct since the start of modern oncology clinical testing,” they comment.
“But it also represents an opportunity to rethink the key aspects of clinical trial conduct that are strictly necessary to reach the goal of testing the effectiveness of cancer therapies, and which others are dispensable or provide only minor additional contributions,” they add.
As previously reported at the time by Medscape Medical News, efforts to find alternative approaches to conducting trials amid the pandemic led to the emergence of a few “silver linings.”
Key adaptations made to clinical trials and highlighted by the authors include:
Uptake of remote consenting and telemedicine
Use of alternative laboratories and imaging centers
Delivery or administration of investigational drugs at patients’ homes or local clinics
Commercial attainment of study drugs already approved for other indications
Indeed, the restrictions encountered during the pandemic underscore the importance of designing patient-centered trials versus study site–centered trials, added Antoni Ribas, MD, commentary coauthor and immediate past president of the AACR.
Many of the changes implemented during the pandemic could help increase access for patients living in underserved communities who are underrepresented in clinical trials, he explained.
Harnessing the Lessons Learned
The authors also recommend the following additional adaptations, which they believe will enhance efficiency and further expand access to clinical trials:
Incorporating patient-reported outcomes and alternative endpoints in efficacy assessments
Aiming for 100% remote drug infusions and monitoring
Increasing funding for clinical trials conducted in underserved communities
Expanding clinical trial eligibility to include patients with a wide range of comorbidities
Reducing collection of low-grade adverse events and allowing minor protocol deviations
The group’s recommendations are based on discussions by the AACR COVID-19 and Cancer Task Force, in which they participated.
The American Society of Clinical Oncology (ASCO) is also working to leverage pandemic-related lessons to streamline care and trial planning.
ASCO’s “Road to Recovery” recommendations, published in December 2020, aim to “ensure lessons learned from the COVID-19 experience are used to craft a more equitable, accessible, and efficient clinical research system that protects patient safety, ensures scientific integrity, and maintains data quality,” the authors explain.
Flaherty and colleagues further underscore the importance of focusing on improvements going forward.
“Guided by lessons learned, many of the remote assessments and trial efficiencies deployed during the pandemic can be preserved and improved upon. We strongly encourage use of these streamlined procedures where appropriate in future prospectively designed cancer clinical trials,” they write.
Flaherty has reported receiving personal fees from numerous pharmaceutical companies. Ribas has reported receiving grants from Agilent and Bristol Myers Squibb.
Cancer Discov. Published online July 21, 2021. Abstract
Sharon Worcester is an award-winning medical journalist at MDedge News, part of the Medscape Professional Network.
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