FDA has announced plans to fund a heart disease registry for pediatric patients. The registry would help facilitate pediatric cardiovascular device reviews, expedite new device approvals, facilitate post approval studies, and enhance ongoing post-market surveillance.
Currently there is no pediatric cardiology registry that is designed to handle FDA post-market surveillance challenges. Also needed is valid reference data for the development of alternative premarket clinical trial designs, standard definitions, and the ability to link different databases.
FDA wants to provide a registry that will assess the prevalence, demographics, management, and outcomes of patients with congenital heart disease who are undergoing diagnostic catheterization and catheter-based interventions in the U.S.
The collection and analysis of the data will provide performance measurements, benchmarking, and quality improvement initiatives. The registry will also provide for long term data collection and the ability to capture imaging and clinical outcomes when patients return for care for related or unrelated issues.
The FDA pre-solicitation notice for the registry was posted on August 7th has the response date of August 20th. For information on the pre-solicitation notice, go to www.fbo.gov. FDA on or about August 21st plans to issue a full Request for Proposal (RFP) for the registry and the RFP (09-223-SOL-00214) will be posted on www.fbo.gov. For more information, contact Jacqueline Richardson at jacqueline.richardson@fda.hhs.gov.
FDA has made funding available to support the Office of Critical Path Programs (OCPP). The initiative launched by FDA in 2004, is working with other Federal, academic, scientific, and industry organizations to develop new innovative tools involved in FDA regulated product development. The program is looking for tools to include novel biomarkers, laboratory assays, genetic tests, and state-of-the-art information technologies.
Many of the scientific tools used today to predict and evaluate safety and effectiveness as well as manufacturing products are now decades old, time consuming to use, cumbersome, may be imprecise, and may fail to predict specific safety problems.
Better tools to predict and detect safety problems are needed early in the Critical Path. At that point, products that are likely to fail would be weeded out and then developers would be able to focus on products with a high probability of safety and effectiveness. Also needed are tools to guide the sponsor of a drug in choosing the appropriate dose and regimen or in the case of medical devices, the right size and placement. Manufacturers need tools to better mass produce an approved medical product such as a vaccine and to be able to evaluate the quality of the finished product.
FDA will award a single source Cooperative Agreement for $1.5 million to go to the Critical Path Institute (C-PATH). Competition is limited because of FDA’s ongoing collaboration with the University of Utah and the Critical Path Institute.
The FDA Office of Critical Path programs is also working with the Harvard Clinical Research Institute (HCRI) to fund a Dual Anti-Platelet Therapy (DAPT) clinical trial. Currently, there is uncertainty about the optimal duration of DAPT and it is unclear as to whether the duration of the therapy in patients receiving drug eluting stents should be 3-6 months, 12 months, or even longer. Plans are for a trial to be conducted with four device manufacturers and two drug manufacturers under the direction of HCRI.
