The US Food and Drug Administration’s (FDA) has issued a trio of draft guidance documents that aim to promote greater participation and diversity in oncology clinical trials by expanding eligibility criteria. The documents address three areas: laboratory values, washout periods and concomitant medicines, and patient’s performance status.
These new guidance documents stem from FDA’s push over the past five years to broaden the criteria to participate in oncology clinical trials of investigational drugs or biological products regulated by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) on the premise that some sponsors are using eligibility criteria that are not based on sound science. (RELATED: FDA Unveils 5 Guidances on Broadening Cancer Clinical Trial Eligibility, Regulatory Focus 12 March 2019)…
