Pursuant to the FDA’s draft guidance on clinical trial enrichment strategies that was released at the tail-end of 2012, a growing number of drug companies are asking for the agency to provide examples of exactly how the recommendations made by the guidance can be implemented in real world practice. Specifically, industry players are looking for … continue reading
Adaptive clinical trials can dramatically improve clinical trial efficiency and productivity, and are rapidly gaining traction in our industry. They have strong regulatory and ethical backing, save significant amounts of money, improve critical decision-making, and can reduce late-phase attrition. Join industry experts from Roche, Novartis, Boehringer-Ingelheim, and others in a complimentary half-day seminar to discuss … continue reading
Join Aptiv Solutions for a corporate showcase presentation and cocktail reception at the 32nd American Pain Society Scientific Meeting taking place May 8-11th in New Orleans, LA, and learn why adaptive design is critical to your drug development program. Selecting the right dose to take forward to phase III trials is a critical step in … continue reading
It’s been a common complaint from the FDA concerning the approval of not just drugs but also devices: study protocols that do not conform to the quality standards of the appropriate regulatory body. The problem is certainly not restricted to the American market, and a new guideline published in the Annals of Internal Medicine designed … continue reading
Adaptive design trials are on the cusp of playing a major role in fighting one of the most mysterious and debilitating diseases afflicting senior citizens. Bioworld is reporting that Genentech’s contribution to the international Alzheimer’s Prevention Initiative (API) will take the form of an adaptive trial investigating crenezumab. Crenezumab is an anti-amyloid antibody that has … continue reading
Ask almost any pharma executive what is the most expensive aspect of a given drug investigation and the answer is universal: Phase III trials. Phase III clinical trials have become more and more costly over the past decade, with some reports estimating that 90 percent of development costs for a marketed drug are spent at … continue reading
Traditional randomized clinical trials (RCTs) have been targeted by those who claim that their inefficiencies and excessive costs are a major stumbling block for modern drug development. When compared against alternatives, such as adaptive trial design, RCTs are starting to lose ground as greater numbers of companies move towards newer strategies in order to reduce … continue reading
A portfolio-wide adaptive trial design strategy can only be useful once it has been embraced by a pharma company’s leadership team. Getting to that point, however, means overcoming a number of barriers, such as the availability of specific adaptive trial expertise, as well as access to fully validated software packages to help researchers design their … continue reading
The key component of adaptive clinical trial design that makes it so valuable to pharmaceutical companies is the interim analysis that is performed during the course of an investigation. This interim analysis provides the data upon which the decision to implement a pre-planned design change is made. This design adaptation can alter the course of … continue reading
Adaptive trials bring substantial benefits to the table when it comes to structuring a clinical investigation. Primarily, adaptive trials make a difference where it counts the most: improving the chances of success in Phase 3 clinical trials. With half of Phase 3 studies across the pharmaceutical industry still failing, the need to adopt a new … continue reading
