FDA Seeks to Broaden Clinical Trial Eligibility Criteria
FDA released four new draft guidances that seek to broaden criteria for identifying and enrolling patients in clinical trials in an effort to reduce time and cost of clinical research for biopharmaceuticals.
To reduce the time and cost involved with conducting clinical research on new biopharmaceuticals, regulators and researchers are looking to broaden outmoded criteria for identifying and enrolling individuals in clinical trials. Sponsors traditionally have shied away from including young patients and those with infectious diseases or comorbidities that might raise safety issues or compromise efficacy results. Their aim is for clinical trials to generate data that will support market approval of new drugs, biologics, and medical products, and to avoid studies that involve children, small patient populations, or patients in poor health that may generate confusing or questionable data.
At the same time, restrictions on clinical trial participation may “slow patient accrual, limit patients’ access to clinical trials, and lead to trial results that do not fully represent treatment effects in patients that ultimately will use the drug,” explained outgoing FDA Commissioner Scott Gottlieb March 12 in unveiling a
The new guidances specifically address clinical studies for new cancer treatments, where a broadening of eligibility criteria would enable more people to participate in oncology trials, a field where patient accrual is difficult, but where the serious nature of disease may lend itself to more flexibility in enrollment criteria. Including children, adolescents, and individuals with infectious diseases, malignancies, and metastases may yield results that are more generalizable and help improve our understanding of a therapy’s benefit-risk profile across populations likely to receive the drug in clinical practice, Gottlieb explained.
One guidance finalizes an earlier proposal for including adolescents in adult oncology trials where the age of 18 is the traditional cutoff point. The rationale is that many cancers found in younger patients often behave similarly in adults, and that excluding adolescents from clinical studies may delay their access to potentially effective therapy. The
Patients with HIV or hepatitis infections should not be ruled out of participation in clinical trials, says FDA in another
Another guidance addresses criteria for cancer trials to include patients with organ dysfunction (renal, cardiac, hepatic) or previous malignancies.
FDA sees a need to study patients living with cancer who increasingly are diagnosed with brain metastases, in an effort to discourage exclusion of such individuals from clinical research.
The four new draft guidances were developed by FDA with input from the American Society of Clinical Oncology and Friends of Cancer Research. These policies aim to ensure that clinical trials are designed to reflect “the diversity of the population that receives drugs in the real world,” said Gottlieb, and to help design oncology trials to be “more representative of the patients that may ultimately benefit from novel treatments.”
Jill Wechsler is the Washington Correspondent for Applied Clinical Trials
Articles in this issue
Newsletter
Stay current in clinical research with Applied Clinical Trials, providing expert insights, regulatory updates, and practical strategies for successful clinical trial design and execution.
Related Articles
- Generative AI Transforms Clinical Study Report Development
September 16th 2025
- Operational Strategies That Strengthened the NIMBLE Trial Design
September 16th 2025