Regulatory Focus - Include cancer patients in COVID-19 vaccine trials, say ASCO and Friends of Cancer Research
People with cancer should be included in COVID-19 vaccine clinical trials, according to a new joint position statement from the American Society of Clinical Oncology (ASCO) and the Friends of Cancer Research (FCR).
“We’ve learned that patients with cancer are especially vulnerable to severe illness, hospitalization, or death due to COVID-19,” said ASCO President Everett E. Vokes in a joint press release announcing the position statement. “It is critically important to study adequate numbers of patients who have cancer or a history of cancer so that we can better understand the degree to which patients with cancer, various kinds of immunocompromise, or both respond to vaccines.”
The joint statement builds on other work from both organizations that supports broadening eligibility criteria for cancer clinical trial participation. “We continue to emphasize that broadening eligibility criteria to clinical trials will help inform the optimal use of new medicines for more people, and the same principles apply to COVID-19 vaccines,” said Jeff Allen, president and CEO of FCR. (RELATED: AACR: Minority accrual in clinical trials is a team sport, Regulatory Focus 23 June 2020)
For COVID-19 vaccines, more must be known about the safety and efficacy of vaccines in special populations, including individuals with cancer or a history of cancer, wrote the organizations: “As more studies address special populations, it is critically important as part of vaccine development to study adequate numbers of patients who have cancer, have a suppressed immune system, or who are on immune-modulating treatments, to better understand the degree of immune response in this vulnerable population.”
Clinical trials for COVID-19 vaccines have so far “almost universally excluded” patients who are in active cancer treatment, to the detriment of the knowledge base about how the vaccine will work in people receiving these treatments, according to the position statement. “If there are specific concerns about immunogenicity and efficacy for a vaccine (e.g., in patients receiving chemotherapy, immunotherapy, CAR-T therapy, or transplants), priority consideration should be given for inclusion of cohorts of those patients in the prospective vaccine’s trials,” wrote the organizations.
It is possible that the subset of vaccine recipients who have a suppressed immune response will respond differently to the vaccine, with the potential for a less robust immune response or a shorter duration of response. Only by studying these populations will these differences be discovered; “those data should be generated, appropriately analyzed, and disseminated as rapidly as possible,” according to the position statement. (RELATED: Woodcock: Post-COVID, new flexibility could boost cancer trial diversity, Regulatory Focus 09 April 2021)
The position statement includes four concrete recommendations regarding inclusion of people with cancer in clinical trials of COVID-19 vaccines. First, trials should be designed to be “as broadly inclusive as possible,” only excluding those with a current or past history of cancer if the trial poses “specific and credible risk of harm.”
Second, those designing and running trials should partner with academic medical centers, cancer centers and oncology practices to boost recruitment of patients with cancer. Such a strategy should help garner enough enrollees, and generate enough diversity in the trial population, that valid subset analyses can be done.
Third, government agencies should also help boost participation of people with cancer in COVID-19 vaccine trials by providing incentives to vaccine manufacturers.
Finally, the statement encourages real-world data collection on effectiveness of COVID-19 vaccines in patients with cancer. “For populations underrepresented in prior vaccine trials, this data collection would enable the most comprehensive understanding of practical clinical considerations,”
ASCO-FCR joint position statement