FDA Modernizes Clinical Trial Designs
Master Protocol Designs Mean Increased Competition
The FDA has updated and modernized its clinical trial designs. That means a lower cost, more efficient process leading to a more competitive market and lower prices. Not only will this make it easier to bring new treatments to market, it will also increase the amount of similar treatments. That means shorter time frames for companies first to market to have a monopoly over treatments. It also means patients have greater choice within a class of drug.
The game changer here is the modernization of clinical trial design, for example master protocol designs. This allows for clinical trials of multiple drugs or multiple applications of a single drug or even multiple patient populations under the structure of a single study. This is a far less expensive and far more streamlined process than what has previously existed. What’s more, master protocol designs yield greater information about each individual treatment, application or population.
Of course, these trials are also far more complex, highlighting the need to work with an organization specializing in statistical data analysis and not a “one-size-fits-all” biostatistical research organization. The FDA has also issued two new draft guidance papers, so it’s important to work with a clinical biostatistical research organization who knows the ins and outs of these news guidance papers.
The first draft guidance informs sponsors of what information the FDA will want as part of a master protocol design, as well as best practices for interaction with the FDA for facilitating efficient review and patient safety. The second draft guidance addresses principles for designing, conducting and reporting results from a study modified during trials. These studies are known as adaptive trials.
The FDA is currently accepting public commentary on these draft guidances.
Related Information:
- Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics Guidance for Industry
- Adaptive Design Clinical Trials for Drugs and Biologics
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