Prior to the approval of new drugs, substantial evidence of efficacy is required and safety brought through clinical trials. A massive decline in success rates in Phase II/III of clinical trials has resulted in only 1 in 10 drugs successfully passing through these trials in the US.
With increasing pressure to bring drugs quickly into the market and reduce the cost of drug development, the paradigms of drug dosage studies in phase II trials and the overall adaptive framework of clinical trials are being increasingly challenged. Thus, strategies such as “Seamless Adaptive Designs” and “Group –Sequential Adaptive Designs” are particular areas that have received a great deal of attention in helping to improve the efficiency of drug development.
This conference will review the drug development process and provide a detailed discussion of how
adaptive designs are changing the development process. The main focus of the presentation will be to explore the role of adaptive sample sizing; in particular, why it is important to consider the need to reassess sample sizes during the course of a trial. It is designed for those looking to network and gain the latest knowledge from the academics, industry leaders and regulators.
Benefits of Attending
Now entering our 7th year in hosting
Adaptive Designs in Clinical Trials, we continue to draw high level speakers from around the globe whom are steering the innovative climate of adaptive designs to improve clinical trials.
With a strong international focus, the conference will highlight key areas of innovation from Novel Responsive-Adaptive Designs that can optimise dose-finding strategies, to multi-armed Bayesian bandit models, Seamless adaptive designs and adapting real world data.
The conference will also appeal to those looking to understand regulatory submissions across the international landscape, including parallels and discrepancies between the FDA, EMA and PDMA methods of regulation, not to mention MAPPs and Adaptive Licensing!
Why not gain an insight into what may often be overlooked as the implimentation of adaptive protocols in emerging markets from the CEE region?
- Listen to talks on new predictive biomarker designs used to separate sensitivity levels in patients
- Enhance your understanding of Bayesian survival models and how Bayesian belief networks can leverage operational risks in clinical trials
- Join the discussion on the recognised need of real world evidence to enhance the flexibility of adaptive clinical trials and improve patient care
- Explore the novel applications of adaptive designs in early and late phase clinical trials
- Learn novel design strategies in Bio-marker driven adaptive designs from Multi Arms Multi Stage (MAMS) trials to adapting Group Sequential Enrichment Designs and Combination Tests: How may these establish appropriate cut off points to distinguish sensitive and insentsitive patients?
Plus Two Interactive Half-Day Post-Conference Workshops | 22nd April 2015
Bayesian Adaptive Clinical Designs and StrategiesWorkshop Leader: Dr. Sophie Carr, MD and Principal Analyst, Bays Consulting Ltd.
8.30am – 12.30pm
Winning with Adaptive Trial Strategies and Clinical Compliance Across the Evolving International Regulatory LandscapeWorkshop Leader: Robert Clay, Consultant, Highbury Regulatory Science, Chief Regulatory Officer, Kinapse, Board Director, TOPRA
1.30pm – 5.30pm
