Clinical trials must be accessible to all

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The theme for this year’s American Society of Clinical Oncology (ASCO) Annual Meeting is “Advancing Equitable Cancer Care Through Innovation,” and in this interview, Randall A. Oyer, MD, Director Medical Officer, Oncology, and Medical Director, Cancer Risk Assessment Program, Lancaster General Health, and Clinical Professor of Cancer Biology at Penn Medicine, discusses recent ASCO/Association of Community Cancer Centers (ACCC) recommendations for improve diversity in clinical trials.

Oyer is the lead author of the article “Increasing Racial and Ethnic Diversity in Cancer Clinical Trials: American Society of Clinical Oncology/Association of Community Cancer Centers Joint Research Statement”, recently published in Journal of Clinical Oncology. He is also a past president of the ACCC.

Transcription

Did you notice any changes even before these recommendations?

In April, the FDA released draft guidance for industry that a racial and ethnic diversity plan is recommended for all medical products for which an IND [investigational new drug] a submission is required and for clinical studies that support a marketing submission. Sponsors are advised to discuss a racial and ethnic diversity plan with the FDA as early in the process as possible and at any intervals along the way. Sponsors are also encouraged to define enrollment goals and the methods they will use in a trial to ensure diversity goals are met.

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We’re not going to be where we want to be in cancer care, or where we know we can be in cancer care, without improving clinical trials, and improving clinical trials means that they are accessible to all.

What is the role of community oncology practices in promoting greater diversity in clinical trials?

In the United States, most cancer patients receive their care in the community setting rather than at the academic medical center, which means that clinical trials must be conducted directly in the communities where patients receive their care. Yet 75% of the problem with patients not being offered clinical trials is because a matching clinical trial is not available where a patient is being treated.

Community practices now understand that cancer treatment trials are a component of high quality care, and we see community practices investing in people, systems and training, working with an academic partner, working with industry or be part of a cooperative group that can make relevant trials available to patients in their communities. ACCC and ASCO also recommend forming strong partnerships in every community: with patients, patient advisory groups, and with community organizations and leaders.

What role do payers specifically play in bringing greater diversity to the research process?

Well, payers can and should allow their clients and beneficiaries to participate in clinical trials. They must cover the trial costs to the same extent that they cover the standard of care. No policy should exclude clinical trials.

Does the CMS have a specific role to play in this process?

CMS can make participation in clinical trials, I believe, one of the measures of quality that they track, measure, report and value through an advanced payment model. This is a quality component of the oncology care model, the now 6 year pilot project nearing completion.

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