FDA Rolls Out New Drug Research and Development Pilot Program

    It’s no secret that some of the biggest challenges faced by the healthcare industry revolve around data and transparency. Improving the patient experience, keeping personal information safe, and developing better infrastructure are just a few of the issues in this realm. And while not every one of these issues can be solved overnight, there are many areas in which we can improve by just thinking smarter about data.

    Thinking smarter about data is precisely what the Center for Drug Evaluation and Research (CDER) is doing with its new Clinical Data Summary Pilot Program. Launched earlier this year, the program supplies researchers, stakeholders, providers, and other healthcare professionals with detailed information from the Clinical Study Reports (CSRs) of new drug applications (NDAs).. Key sections include complete result summaries, protocol information, and statistical plans. This is a considerable step up from the current drug approval action packages, which are quite lackluster when it comes to providing this data.

    Throughout the program, the CDER will publish CSRs from nine approved new drug applications. The first, which was published to the FDA’s website in mid-March, is Erleada, a breakthrough treatment for non-metastatic, castration-resistant prostate cancer developed by Janssen Biotech. Not only is it the first FDA-approved treatment of its kind, but it’s also the first to use the clinical trial result of metastasis-free survival.

    While there are many anticipated benefits of this program, the FDA’s ultimate goal is to promote an increased understanding of how the organization reaches approval decisions. Access to this data can be used to improve your submission strategy and highlight gaps in your current documentation. Additionally, this decision also puts the FDA on par with its EU counterpart, the European Medicines Agency, as they are making similar changes to the way their data is shared.

    To evaluate the success of this pilot and determine how usable the data provided is, the FDA will seek feedback when the program ends. Be sure to stay tuned to the pilot program’s website for the latest information.