Proactivity Is Key When It Comes to COA Studies

Anthony Blank, vice president of cardiovascular regulatory affairs for Boston Scientific, offered some pointers during a session at the Regulatory Affairs Professionals Society meeting this week.First, he said, the company needs to work with FDA to determine what the key unanswered questions will be at the time of approval. Once those are identified, the sponsor needs to determine what their data requirements are, and whether a COA study is the best way to get that data. "What steps can be taken to maximize data integrity and minimize complexity?" he asked. "How might the data enhance patient care? Never forget that. You have to walk away with answers to those questions before you agree to a COA."Second, firms should make sure the studies aren't too complex. "Study procedures outside the range of normal patient care will impede enrollment and create noncompliance issues," he said. "A complicated patient enrollment process will delay enrollment. Extra patient follow-ups will lead to missed visits. And collection of extra data without a plan can lead to new questions. The data need to be as reliable as they are in premarket studies."His other recommendations include:* Know the COA requirements for similar devices, and understand their successes and challenges. Do not underestimate the complexities and challenges associated with a COA study.* Meet with the FDA review team often. Discuss the likelihood of a COA study being needed, and what questions it should address. Discuss alternative sources of data, such as literature on similar products. These discussions can help firms design better premarket studies as well.* If applicable, reach an agreement on a COA study design before the advisory panel meeting. Panel members like to offer suggestions about COA study design, and their ideas are often not practical.* Don't commit to a study that's impractical or too expensive. It is tempting to agree to whatever the agency asks for in order to get the PMA approved as soon as possible. But rubber-stamping FDA's offer could lead to problems later.* Explore getting a continued-access IDE. This will enable a sponsor to start collecting COA data before final PMA approval.