There’s a good article recently published on the Stanford University Medicine website on the revolution going on in the development of cancer cures and the part adaptive trial designs can play in it. Read more
The randomized controlled trial has taken medical research to a high scientific plateau. But it is more than 60 years old and had changed very little over that period. We cannot be satisfied with the status quo. Read more from Don’s interview with the ASCO post at: http://www.ascopost.com
It is good to see recommendations for the FDA to be funded so they can better review and help foster adaptive clinical trials…read more
Focus group and survey confirm growing complexity of drug development and increasing adoption of smarter clinical trials Tom Parke, Head of Clinical Technologies, Tessella I was lucky enough to join a focus group at the recent 8th Annual SAS Health Care & Life Sciences Executive Conference (http://www.sas.com/news/preleases/hlsconf-clinicaltrials.html). The group comprising of selected pharmaceutical industry executives, [...]
What’s Wrong with Phase II Trials? Genetic Engineering News Dr. Miller noted that the use of adaptive designs “should go a long way in increasing the likelihood of a successful early-phase clinical trial. … http://www.genengnews.com/analysis-and-insight/what-s-wrong-with-phase-ii-trials/77899364/
“One of the examples we’ve being using for a while now to demonstrate and teach FACTS is a dose finding trial around an HIV treatment. This has now been worked up into quite a detailed example, examining what benefits accrue in this case from different design features such: as dose response modeling, longitudinal modeling, adaptation [...]
“I attended IQPC’s conference on “Innovation in Clinical Design and Analysis Reporting” in London last week. This was a good conference with a lot of good speakers. As well many interesting case studies, there were two talks, one on reimbursement and the other on analysing and reporting safety data which made me realise that there [...]
It was very heartening to read that Margaret Hamburg, commissioner of the FDA, is actively supportive of the development of new techniques for studying the safety and efficacy of new medicines. In particular to read that approaches such as adaptive clinical trials should be looked at. The FDA clearly recognise the increasing complexity of drug [...]
In Feb 2010 the FDA issued a draft guidance for industry on “Adaptive Design Clinical Trials for Drugs and Biologics” (pdf). Join me in this on-demand webinar as I quiz adaptive trial gurus Prof Don Berry and Dr Scott Berry on the implications of the FDA Guidance. I will be getting answers to the key [...]
Register for our live webcast on Tuesday, 8 June 2010 08:00 (PDT) 11:00 (EDT) 16:00 (BST) 17:00 (CEST) Join me as I quiz adaptive trial gurus Prof Don Berry and Dr. Scott Berry on the implications of the recent FDA Guidance on Adaptive Design for Clinical Trials. I will be getting answers to the key questions [...]
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