Regulatory agencies and the clinical research industry as a whole have put increasing emphasis on diversity among trial participants. But there’s much less urgency around building diverse research teams, even though evidence shows that doing so can benefit everything from participant recruitment to trial operations to innovation and collaboration. Read More
Clinical research sites often turn to community-based organizations (CBO) when it’s time to identify and recruit patients from specific populations for clinical trials. And while those local connections are a great source for finding diverse participant pools and for publicizing new studies, CBOs can be a valuable, long-term resource for research sites in other ways, too. Read More
The FDA’s Center for Biologics Evaluation and Research (CBER) has issued an updated agenda of guidances it intends to publish this year, indicating there are still two clinical research documents the center intends to address by the end of the year. Read More
To encourage development of drugs to treat serious bacterial diseases in patients with an unmet medical need, the FDA has updated a 2017 guidance on antibacterial drug development to indicate the agency may be willing to accept more flexible development programs. Read More
To help support a global approach to developing new drugs that address antimicrobial resistance, the European Medicines Agency (EMA) has published a final guideline aimed at aligning data requirements with other countries’ regulators. Read More
In an effort to get more gonadotropin-releasing hormone (GnRH) analogues to market for advanced prostate cancer patients, the FDA has published final guidance that advises sponsors to conduct single-arm trials using T levels as pharmacodynamics/response biomarkers. Read More
