A recent article published at Applied Clinical Trials Online presented a confusing viewpoint on the role that adaptive clinical trials play in the current pharmaceutical landscape. Titled “Adaptive Trial Design: From a Recruiter’s Perspective,” the piece puts forward several misconceptions about how adaptive trial designs are intended to improve clinical efforts. The article also clouds … continue reading
It’s been a long wait – in fact, it took the FDA six years to put together this particular document – but a draft guidance has been issued that aims specifically at improving the quality of the data gathered by clinical trials. “Enrichment Strategies for Clinical Trials to Support Approval of Human Drugs and Biological … continue reading
The Journal of Bone and Joint Surgery has published an in-depth look at the advantages of adaptive clinical trials. The article, entitled “Adaptive Bayesian Randomized Trials: Realizing Their Potential,” was written by Eleanor M. Pullenayegum, PhD, and presents several compelling and well-researched arguments concerning how adaptive trials can improve clinical investigations. The article is set against … continue reading
Aptiv Solutions will be sponsoring a one-day conference focused on ‘Delivering Innovation and Efficiency Through Adaptive Clinical Trials,’ on October 22, 2012. In partnership with Berry Consultants and Tessella, Aptiv will provide a forum for pharmaceutical industry professionals to discuss the advantages and opportunities available through the adoption of adaptive trials designs. Helping Aptiv Solutions … continue reading
A recent article published by the Journal of the American Medical Association questioned several aspects of the ethics behind adaptive clinical trial designs. Specifically, the article concluded that clinicians needed to recognize and address various issues in order to ensure the ethical and scientific validity of adaptive trials. One of the points brought up by … continue reading
Join us for a free webinar, offered on September 18 and September 19 at 10 a.m. BST. The one-hour program will provide outsourcing managers and procurement professionals with a clear understanding of the importance of adaptive design trials for both patients and industry. Learn how adaptive design trials can improve R&D efficiency and productivity, with … continue reading
Aptiv Solutions will be sending Judith Quinlan, Senior Vice President, Adaptive Trial Design & Implementation, Innovations Center, to the upcoming Disruptive Innovations to Advance Clinical Trials conference in Boston, MA. This conference, which runs from September 13 to September 14, is focused on highlighting the work and ideas of individuals in the drug development community … continue reading
A financial push from the FDA could see adaptive trial design take a starring role in the World Health Organization’s (WHO) vaccine clinical trial design initiative. The Center for Biologics Evaluation and Research (CBER) has $12 million to spend on improving innovation and safety (link to article, subscription required) for vaccines and vaccine development, and it has stated … continue reading
Presented by Amy Kneifel, Director, Regulatory Affairs, Aptiv Solutions The prescription drug user fees provided by PDUFA are an integral part of the FDA’s ability to efficiently review new drugs. PDUFA fees allow the FDA to hire additional staff, and give it the tools and resources to make the drug approval process thorough, objective, and … continue reading
The establishment of the dose-response relationships for efficacy and safety (toxicity) of a particular treatment is an important aspect of early-stage Phase I and Phase II investigations. Adaptive design trials have proven to be uniquely well-suited in helping clinicians more effectively collect the data they require regarding safe and effective dosing due to the ability … continue reading
