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FDA Lists Four Expectations from Oncology Drug Developers
(Thursday, February 9, 2023) In its fifth annual report, FDA’s Oncology Center for Excellence (OCE) listed its expectations for modernizing oncology clinical trials. In its sixth year of operations, the OCE wants to move beyond the work it has accomplished so far and focus on patient and physician perspectives for oncology drugs in clinical trials or available currently in the clinic. There are four aspects of oncology drug development programs that would win over OCE support. First, the demographic distribution of trial participants should adequately reflect the intended target population for the products. Sponsors should implement policies to ensure adequate enrollment of historically underrepresented and vulnerable subgroups of the population, incorporate internal and external stakeholders on efforts to promote equity in clinical trials, and present data analyzing outcomes across subgroups. Second, sponsors should plan pragmatic clinical trials with less complex trial designs incorporating elements that are more reflective of routine clinical practice. OCE would support trials with fewer and simpler eligibility criteria, flexible trial operations reflective of "real-world" setting to reduce the burden of trial participation intended to facilitate more diverse trial populations, more rapid enrollment, reduced attrition, and resulting evidence that is more broadly representative of the target treatment population. Third, OCE would support trials evaluating new drugs that target specific molecular alteration(s) (such as biomarkers) that are shared across multiple cancer types so that the resulting treatments have applications across multiple cancer types rather than a specific subset of cancer. This tissue agnostic treatment development would potentially have higher impact on managing multiple types of cancer and will be prioritized over more cancer-type-specific treatments. Fourth, sponsors should conduct dose-finding and dose-optimization early on where the efficacy and tolerability along safety of the dose of a new drug is identified in early stage clinical trials via a combination of non-clinical evidence and small pilot clinical trials. OCE wants to encourage the concept of “less is more” where smaller doses of a drug are more clinically effective than larger doses. In addition to the above four expectations from ongoing clinical development plans, OCE plans to review and evaluate relevant scientific evidence from published literature for previously approved oncology drugs, which might reflect mostly post-market real world clinical experience, to update product labeling, including potential new indications for use based on this evidence. The updated labels informing current safe and effective use of oncology products would reduce potential risk of patients and improve clinical outcomes. This may also add new treatment options for patients from within the previously approved products much quickly than the new drugs in development. The OCE wish-list in its annual report is quite reasonable, and expectations set in it are realistic. These also reflect the overall focus of FDA as an organization on modernizing drug development for all diseases, not just oncology drugs. But by providing specific FDA contacts for each of the four aspects of oncology drug development, the OCE has provided a comprehensive resource it its stakeholders. 
AUTHOR
Dr. Mukesh Kumar Founder & CEO, FDAMap Email: [email protected] Linkedin: Mukesh Kumar, PhD, RAC Instagram: mukeshkumarrac Twitter: @FDA_MAP Youtube: MukeshKumarFDAMap |
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