Join us on June 18, 2013 when Aptiv Solutions, industry experts, and the FDA will participate in the RAPS Virtual Workshop, “Understanding the Regulatory Landscape for Adaptive Design Trials.” Adaptive design trials are gaining wider acceptance across the drug, medical device, and diagnostics industries and have the potential to increase development efficiency, productivity, and the … continue reading
Early Phase Adaptive Design Trials: Execution Requirements, Organizational Challenges and Economics
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
Using Adaptive Design to Improve Dose Selection in Exploratory Phase Pain Trials
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
Adoption of Adaptive Design Trials on the Increase
The Tufts Center for the Study of Drug Development recently hosted and facilitated a senior executive roundtable in Boston to discuss the adoption and impact of adaptive clinical trial design. The event, supported by an educational grant from Aptiv Solutions, involved forty senior executives from a variety of cross-functional areas including clinical development, biostatistics, project … continue reading
Using Innovative Adaptive Design to Improve Outcomes in Drug & Medical Device Development
Aptiv Solutions has teamed up with OCTANe to create to two cutting edge breakfast seminars on the use of innovative adaptive design in drug and medical device development. The seminars will focus on the latest developments in this field including feedback from an Executive Roundtable held at the Tufts Centre for the Study of Drug … continue reading
SPIRIT 2013 Checklist Outlines Minimum Clinical Trial Protocol Content
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
AstraZeneca and DDO Team Up For Adaptive Cancer Trial
Adaptive trial design adoption gained a major push recently with the announcement that AstraZeneca will be partnering with the Drug Development Office (DDO) of Cancer Research UK in order to investigate AZD0424. AZD0424 is being tested as a possible treatment for several different types of cancer, and the three-arm clinical trial will follow an adaptive … continue reading
Genentech Rolls Out Groundbreaking Adaptive Trial
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
Adaptive Trials Promise Shorter & More Affordable Phase III Trials
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
Adaptive Trials Can Mitigate Biased Data Reporting
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
