A recent article published by Nature indicates that spending more time and focus on Phase 2 trials instead of fixating on moving to Phase 3 as quickly as possible can ultimately save considerable investment on the part of drug companies, as well as improve outcomes.
The article, written by Roxanne Palmer, references research performed by Deloitte Recap concerning the success of just under 100 drugs investigated over the past 10 years. The findings showed that those compounds that were eventually approved for sale underwent a far more rigorous set of Phase 2 trials than the products that were rejected by the FDA late in Phase 3. The ratio of approved to rejected drugs was roughly two-to-one, but even more interesting is the fact that the companies that elected to go with less complex and smaller Phase 2 trials did not see any benefits in terms of time to outcome.
The message seems simple: greater investment in Phase 2 investigation can increase the probability of success at Phase 3. Unfortunately, using traditional designs, not all companies are in a financial position to adopt this philosophy, particularly for a novel molecule where dose, clinical endpoint, and efficacy in specific sub-populations of patients all need to be determined.
This is where adaptive design trials can make a significant difference in increasing the chances of success for a particular compound. One of the key advantages of adaptive trials is the ability to undertake complex clinical studies that are designed to accurately determine the shape of the dose response curve and the most appropriate end point for a particular treatment. Sponsors can extract high levels of value from trial data thanks to the flexibility of an adaptive design, which brings efficiency as well as focus to reveal any potential stumbling blocks well before a Phase 3 investigation is initiated.
Moving prematurely from Phase 2 to Phase 3 trials is a decision that is often fraught with optimism and pushed by the desire to advance further down the path to reaping the financial rewards of a successful drug. Adaptive trials are an affordable and effective method for gathering the data needed to make this particular choice based on hard evidence rather than external pressures or ambiguous outcomes.
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Benjamin Hunting
Aptiv Solutions Blogging Team
