By Aurora Sosa
Brief background on clinical holds
Following the submission of an investigational new drug (IND) application, the FDA has 30 days to review the application to ensure study participants will not be subjected to unreasonable risk and the study is designed to address its stated objectives. The FDA may issue a clinical hold if there are questions about critical aspects of clinical study design and safety, non-clinical safety, or product quality of the proposed investigational treatment that are not readily resolvable, or there is an inability to conduct the clinical study in accordance with good clinical practice (GCP) guidelines and industry standards.
If a proposed clinical investigation is put on a clinical hold, the sponsor is not permitted to give the investigational treatment to subjects. If an ongoing study is placed on a clinical hold, no new subjects may be administered the investigational therapy. Typically, patients already in the study must be taken off the investigational treatment. Still, there are cases where the FDA permits ongoing administration if the potential benefit appears to outweigh the risks of continued treatment.
A clinical hold from the U.S. Food and Drug Administration can significantly prolong the time and increase the cost of drug development, which is particularly concerning for emerging/small biotech and specialty pharma companies. In this blog, we discuss common reasons for clinical holds and provide useful tips for both avoiding and addressing them.