The Regulatory Affairs Professionals Society (RAPS) will be holding a virtual seminar on adaptive clinical trials June 18, 2013. The half-day event, which will take place online, is scheduled to last from noon EDT until 5 p.m. A number of adaptive trial design experts will be present at the event, which is titled “Understanding Regulatory … continue reading
So-called ‘orphan diseases,’ those which are estimated to afflict fewer than 200,000 individuals in the United States (with similarly low prevalence around the world) have long presented a challenge to drug researchers. Primarily, the issue has been one of locating an appropriately-sized sample population in order to conduct an effective clinical trial. Some rare conditions, … continue reading
Pursuant to the FDA’s draft guidance on clinical trial enrichment strategies that was released at the tail-end of 2012, a growing number of drug companies are asking for the agency to provide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
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
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
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
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
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 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
