Over 30% of people worldwide suffer from chronic pain, making chronic pain studies one of the most vital areas of clinical research and development. Sponsors developing new treatments have the opportunity to support millions of patients around the world with the potential for highly impactful results. However, to get new therapies to market they must first navigate a challenging clinical trial landscape. Providing sponsors with an efficient way to consider larger numbers of design options can help to ensure that effective drugs have the best opportunity to demonstrate their value and reach the market in a timely fashion.
Chronic pain study timelines to prove clinical effectiveness are short, and competition is high. One way to gain a competitive advantage is to adapt to this small window of time by implementing early stopping. If the interim look is too early, however, the risk is that there would not be sufficient data available to justify early stopping. On the other side of the spectrum, pushing the interim look to a later point presents a risk of missing out on the reason for implementing early stopping: to accelerate trials while managing resources. A far superior method is to assess tradeoffs in projected time and resource availability across a range of possible timings for interim analyses. This approach allows sponsors to choose the optimal interim analyses to meet specific trial design needs.
Enterprising biotechnology companies often do not have the in-house statistical capabilities to design a trial that optimizes sample size, duration and power. With minimal options or savings potential many biotech sponsors take a rudimentary approach. They use a minimally desired power to calculate sample size and sometimes add a single interim analysis. While this approach improves upon more traditional trial designs, it leaves unanswered the question of when should the interim analysis be held for strategic design.