AstraZeneca, Novartis, Johnson&Johnson, Glaxo and Boheringer show how they have successfully implemented trials incorporating adaptive designs

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7 leading pharma companies will be presenting at SMi’s 8th Adaptive Designs in Clinical Trials conference.

This conference will go through case studies on how all sizes of pharmaceutical companies have successfully implemented trials incorporating adaptive designs. This conference is the only in Europe that focuses on adaptive designs specifically, providing delegates with updates on recent developments in enrichment design, dose response modelling, computer simulation, internal and external regulatory expectations and new data on evaluating adaptive dose ranging studies.

Key presentations in this conference include:
Application of Adaptive Design in PPP's
•Building infrastructure to apply broadly in a scalable fashion
•Creating an environment where adaptive designs can become the norm
•The execution and how to ensure this happens
Michael Krams, MD, Global Head, Quantitative Sciences, Janssen Pharmaceutical Companies of Johnson & Johnson

Designing a trial to find the minimum inhibitory concentration of an anti-infective drug
•Use of adaptive design to characterize exposure-response relationship
•Addressing the challenge of adaptive dose-allocation under several constraints
•Simulation of operating characteristics to inform design choice
Baldur Magnusson, Senior Principal Statistical Scientist, Novartis International AG

Cost-effectiveness of alternative designs in CV outcome studies
•Fundamentals of sequential and adaptive design
•Robust design of clinical trials
•Decision support using a monetary utility function
•A case-study will illustrate the ideas using simulated data
Mats Kvarnstrom, Principal Statistician, AstraZeneca

Flexible Designs in Phase I Pharmacokinetic Trials
•Basic concepts of Phase I PK trials
•Adaptive and flexible approaches to Phase I bioequivalence trials
•An evaluation of flexible designs vs pilot/main study approaches
•Case studies of group sequential designs in Phase I bioequivalence trials
Frank Fleischer, Principal Statistician, Boehringer-Ingelheim

Case Study: Re-engineering Phase 2
•Phase 2 - the critical pivot point between discovery and full development
•Phase 2 studies designed for their true purpose: as gate-keepers to Phase 3 investment decision-making
•Introduction to the GSK R&D wide initiative called Re-engineering Phase 2 (RP2)
•Dose-response modelling, the formal incorporation of historical data into trial designs; making futility analyses routine within P2 studies and using those P2 data to make formal (Bayesian) predictions of potential Phase 3 outcomes; department-wide quantitative peer review
•The experience of trying to shift an organisation – both within Clinical Statistics and beyond
•Examples from GSK studies where the RP2 principles have been embedded (“before” and “after” examples), and descriptions of the educational material developed and used inside GSK
Graeme Archer, ADD Statistics Director, GlaxoSmithKline

For those interested in this conference please visit the website or contact Husaina Durrant on +44 (0) 20 7827 6070 or email hdurrant(at)smi-online(dot)co(dot)uk

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