Phase 3 Clinical Trials

Phase 3 studies confirm and expand upon the efficacy and safety established in Phase 1 and 2 studies, while also allowing a comparison with existing standards of care.

Expand your body of evidence through large scale studies

While Phase 3 studies can be used to substantiate prevention claims, confirm efficacy, or substantiate structure / function claims for non-drug products, the primary goal of Phase 3 studies is to assess the suitability of your product for authorization from the FDA to release your product as a new drug–prescription or over the counter.

These studies allow the comparison of your product with the existing standard of care, to identify how it may interact with other treatments, and to find rare reactions that may exist. This information is all critical for the compilation of your drug facts label, which will be evaluated during the New Drug Application (NDA) process.

This critical stage of your project requires a unique blend of expertise to ensure results from earlier studies can be replicated in a larger scale with a more diverse population. Our team can work with you to develop studies build around your product’s features to meet FDA standards. Our team also manages expanded participant recruitment, timelines, complex databases, and FDA updates.

About Phase 3 Studies

Phase 3 Trials Identify:

Diversity: These trials provide evidence on how your product’s effects may vary in diverse populations (i.e. by sex, race, geographic region, health status, etc).

Side Effects: What rare side effects and adverse effects are possible? These studies are larger and longer in duration, allowing us to identify the extremely rare effects that may have not occurred in shorter or smaller Phase 2 trials.

Drug Facts: Phase 3 trials supply key usage details required for your product’s comprehensive drug label. Most safety data required by the FDA for drug authorization comes from Phase 3 trials.

Comparison to Standard of Care: Efficacy was demonstrated in phase 2 studies. Phase 3 transitions from "does it work" to "does it work better than the current options?" These trials can provide evidence that your product is the best approach to a certain condition.

Fast Facts

  • Sample Size: Medium to Large (100-1,000 participants per group)
  • Groups: At least one treatment and at least one standard of care group
  • Outcomes: Confirm known effects; no new effects or outcomes
  • Misc: Randomized and Blinded

Preparing for an NDA

The primary purpose of Phase 3 trials is to compile the required evidence and safety data for an NDA (New Drug Application) with the FDA. These are sometimes called pivotal studies or pre-market studies because they play a critical role in the authorization and acceptance of a new drug.

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