Innovative Designs
ADWG KOL Presentation
Adaptive designs
Cardinal Systems has increased its expertise in innovative clinical trial design and is proud to support several Biotechnology and Pharmaceutical companies in their Adaptive Phase III trials with treatment selection.
Cardinal Systems has successfully supported the submission of an adaptive Phase III design including:
- Pre-study simulations
- Parallel scientific advice (FDA & EMA) and PIP submission (PDCO)
- Optimisation of clinical trial workflow
The regulatory and the methodology perspective within the clinical trial arena continuously increases in complexity. At the same time, agencies are still promoting objective market accelerators and the optimisation of study designs for unmet medical needs (see the Critical path initiative, FDA and the Road Map to 2015, EMA). Adaptive design methodology responds to both initiatives.
Combining exploratory (learning stage phase II) and confirmatory (phase III) phases, the Phase III analysis is powered using information from the learning stage to make design choices and combining it with information from the final stage for the Phase III analysis.
Adaptive designs offer new perspectives but create new challenges logistically and methodologically. Cardinal Systems Full services’ offer responds to all requirements and constraints instigated by Adaptive designs:
- A strong expertise in statistical methodology
- The capacity to organise/participate in IDMCs involving both clinicians and statisticians
- Close management of logistical complexities
- A Senior Project manager able to understand and ensure that the appropriate team of experts are available to meet the scientific and technical demands of the study
- An excellence in Information Technology tools including:
- IRS (IVRS/IWRS)
- EDC (eCRF/InfoGate®)
- Medical Imaging (as appropriate)
In addition, thanks to its early specialisation in this niche area, Cardinal Systems Business Development proposes to help in Budget calculation/simulation, Risk analysis and Budget follow-up in Strategic partnership with the sponsor.
References:
- Robust adaptive Phase II/III design based on Posch et al. (2005) methodology
- Critical Path initiative 2004 (FDA)
- Road Map 2015 (EMA)
Statistical Methods In Biopharmacy - Paris September 21-22, 2009 - 6th International Meeting of SFdS
Adaptive designs - a growing demand
Caroline Morgan, speaker at the 4th annual conference in Adaptive Designs
