Cancer Discovery Publishes Article Recommending the Continuation of Certain Pandemic-related Changes to Cancer Clinical Trials

Recommendations point to making clinical trial conduct more patient-centered and efficient

PHILADELPHIA – Today, thought leaders in oncology published an article in Cancer Discovery, a journal of the American Association for Cancer Research, discussing the positive changes to cancer clinical trials brought about by the COVID-19 pandemic and recommendations for continuing these changes after the pandemic.

The authors of the article are Keith Flaherty, MD, the director of clinical research at Massachusetts General Hospital, a professor at Harvard Medical School, and member of the AACR Board of Directors; James Doroshow, MD, a senior investigator at the National Cancer Institute; Susan Galbraith, PhD, executive vice president of oncology research and development at AstraZeneca and member of the AACR Board of Directors; Antoni Ribas, MD, PhD, FAACR, a professor at the University of California Los Angeles and the immediate Past President of the AACR; Paul Kluetz, MD, a deputy director of the Oncology Center of Excellence (OCE) at the U.S. Food and Drug Administration (FDA); Richard Pazdur, MD, the director of the OCE; and Marc Theoret, MD, a deputy director of the OCE.

The authors outline adaptations to clinical trial procedures implemented during the pandemic in four key sectors: academic centers, industry sponsors, government-sponsored clinical trials, and regulatory agencies such as the FDA.

Some of the highlighted adaptations include:

• Uptake of remote consenting and telemedicine to avoid in-person appointments
• Permitting the use of alternative laboratories and imaging centers
• Delivery of investigational drugs to the patient’s home or local clinic
• Administration of intravenous investigational drugs at the patient’s home or at a local clinic
• Commercial attainment of study drugs already approved for other indications

“The restrictions during the pandemic have highlighted that cancer clinical trials should be patient-centered, as opposed to centered on the study sites,” said Ribas, adding that many of the changes implemented during the pandemic could help increase access to patients living in underserved communities that are underrepresented in clinical trials.

“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,” said Flaherty. “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.”

In the article, the authors recommend that these changes continue beyond the pandemic.

In addition, they recommend the following adaptations to enhance efficiency and further expand access to clinical trials:

• Incorporation of patient-reported outcomes and alternative endpoints in efficacy assessments
• Goal of 100 percent remote drug infusions and monitoring
• Increased funding for clinical trials conducted in underserved communities
• Expansion of clinical trial eligibility to include patients with a wide range of comorbidities
• Reduced collection of low-grade adverse events and allowing minor protocol deviations

This manuscript reflects discussions that originated in the AACR COVID-19 and Cancer Task Force, from which this subgroup of co-authors was self-selected to define the scope of the manuscript and contribute to the generation of first and subsequent drafts, as well as the final version.

All AACR journal content related to COVID-19 is freely available in the COVID-19 and Cancer Resource Center.  Flaherty has received personal fees from Clovis Oncology, Strata Oncology, Checkmate Pharmaceuticals, Kinnate Biopharma, Scorpion Therapeutics, X4 Pharmaceuticals, PIC Therapeutics, Apricity Therapeutics, Oncoceutics, FogPharma, Tvardi Therapeutics, xCures, Monopteros Therapeutics, Vibliome Therapeutics, ALX Oncology, and Takeda. Ribas has received personal fees from Amgen, Chugai Phamaceutical, Genentech, Merck, Novartis, Roche, Sanofi, Vedanta Biosciences, 4C Biomed, Appia Bio, Apricity Therapeutics, Arcus Biosciences, Highlight Therapeutics, Compugen, ImaginAb Inc., Kalthera-Immpact Bio, MapKure, Merus, Rgenix, Lutris Pharma, PACT Pharma, Synthekine, Tango Therapeutics, Advaxis, CytomX Therapeutics, Five Prime Therapeutics, RAPT Therapeutics, IsoPlexis, and Kite-Gilead. Ribas has also received grants from Agilent and Bristol Myers Squibb.