Introduction
The Food and Drug Administration (FDA) has announced the availability of two draft guidance documents that could reduce potential risks to trial participants in cancer clinical trials. These documents are for industry professionals, institutional review boards (IRBs), and clinical investigators involved in the development and oversight of clinical trials for investigational drugs regulated by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER).
Cancer Clinical Trial Eligibility Criteria: Laboratory Values
The first draft guidance focuses on “Cancer Clinical Trial Eligibility Criteria: Laboratory Values.” It addresses the crucial issue of eligibility criteria, which play a significant role in selecting the right patient population and minimizing risks for trial participants. Often, eligibility criteria can be overly restrictive, leading to the exclusion of diverse trial participants. The FDA’s draft guidance recommends selecting appropriate laboratory values as trial eligibility criteria, ensuring a more inclusive approach to clinical trials.
Cancer Clinical Trial Eligibility Criteria: Performance Status
The second draft guidance tackles “Cancer Clinical Trial Eligibility Criteria: Performance Status.” Similar to the first notice, this guidance emphasizes the importance of expanding eligibility criteria to include patients with a broader range of performance status. By broadening the eligibility criteria, clinical trials can achieve greater generalizability of results and provide a more comprehensive understanding of the benefit-risk profile of investigational drugs across diverse patient populations.
Comment Period
Stakeholders are encouraged to review draft guidance documents and provide feedback by June 25, 2024. The FDA stresses the significance of considering various factors in developing eligibility criteria, such as the drug’s mechanism of action, targeted disease population, safety data availability, and recruitment feasibility. Comments can be submitted on the official notice pages.
Conclusion
These draft guidance documents represent a significant step in advancing cancer clinical trials. By promoting more inclusive and representative trial designs, the FDA aims to accelerate the development of effective treatments for cancer patients. Stakeholder feedback will be instrumental in shaping the final versions of these guidance documents. Stay tuned for further updates as FDA works towards improving cancer care through innovative clinical trial practices.
View the official notices for more information.
