FDA Finalizes Guidance on Benign Prostatic Hyperplasia Device Studies
The FDA has issued final guidance to offer its advice on designing clinical trials for benign prostatic hyperplasia (BPH) devices, citing the condition’s prevalence in older male populations.
The guidance contains recommendations on designing both feasibility studies and pivotal trials themselves for BPH devices, as well as the types of nonclinical testing that have been found adequate to support applications.
The agency recommends that the pilot study protocol prospectively define the minimum dataset to be gathered to support initiation of the BPH device’s pivotal study. For those studies being done under an investigational device exemption application, sponsors should send the agency a detailed report of the pre-specified pilot study dataset either before or during the request for pivotal study approval.
For pivotal studies, the guidance lays out the main areas that sponsors should address during the design phase and recommendations for doing so. These include the study objective, bias minimization, randomization and controls, study blinding, study endpoints, study duration, statistical hypothesis, sample size and patient selection criteria, among a host of others like study monitoring, post-treatment evaluations and statistical analysis.
Electronic comments may be submitted to the FDA at any time regarding the guidance.
Read the full guidance here: https://bit.ly/3EICpLI.