Hamburg: Focus on Patients, Improve Recruitment

Trial sponsors can boost recruitment and improve their understanding of how drugs work in different groups by turning to patient-centered research and adaptive trial designs, FDA Commissioner Margaret Hamburg and other experts say.

Drugmakers and the agency need to reduce or eliminate barriers to trial participation, Hamburg has said. She recommends sponsors explore adaptive trial designs, whose greater flexibility keeps subjects from feeling “they may be randomly assigned to a [treatment] arm that will have no benefit for them.”

Study subjects must feel they “own and drive” studies they participate in, rather than that they need protection from these exercises, says Joe Selby, executive director of the Patient-Centered Outcomes Research Institute. The more study organizers can foster this attitude, the better their chances of recruiting patients and obtaining larger samples.

Adaptive clinical trials are one of today’s best tools for finding new drugs that improve on existing therapies in targeted populations. Still, avoiding regulatory rejections means sponsors and CROs must know in advance what the FDA does — and doesn’t — want to see in everything from design through final data analysis.

Take your own planning and preparation to the next level by turning the FDA’s preferences into rock-solid best practices for speeding your approval. We can help with Best Practices for Adaptive Clinical Trials: FDA Guidance and Philosophy, a new management report from FDAnews.

Before you begin to modify an existing trial, this report maps out the specific planning and preparation it takes to win FDA approval for adaptive clinical trials. By combining a concise overview with a detailed analysis of FDA’s preferences, this one report advises you on everything thing from the best trial model to use to the best way to avoid technical problems with final data analysis. Don’t let technical problems derail your adaptive clinical trial!