On the 14th August 2014, the ABPI published a position paper entitled "Clinical trial simulations– an essential tool in drug development". This was a joint collaboration between ABPI and PSI. Contributing members from PSI were Alun Bedding and Nigel Brayshaw, with acknowledgement to Andy Grieve for his input during the early part of the collaboration.
The collaboration was as a result of the Seventh Forum of the Ministerial Industry Strategy Group (MISG) held on the 9th September 2010. One of the recommendations from this forum was:
ABPI to consider the value of cross-company collaboration (outside of the competitive arena) to develop effective simulations for different clinical trial scenarios, which would provide better evidence that simulations are a useful tool in clinical trial development. Also to discuss the optimal presentation of simulation studies. Involvement of academic groups sponsoring clinical trials could also be considered.
The collaborators met on a regular basis and the position paper is the output from the hard work.
The paper deals with different simulation scenarios ranging from Clinical Pharmacology, moving through Proof of Concept, Dose Finding to Confirmatory Studies. and outlines the considerations that need to be made. It also outlines what can be achieved with simulations.
It has received positive opinions from the MHRA, DH. NIHR and MRC. Click here
to view the paper.