BCTS is a powerful tool for answering the question, “If I run this trial or clinical development programme according to this design, what is the chance that we will obtain the results we are hoping for?” The Rheumatoid Arthritis Drug Development Model, developed in conjunction with the Centre for Bayesian Statistics and Health Economics (CHEBS) here at Sheffield, used BCTS to simulate Phase 2b and 3 trials based on the efficacy of new drugs at the end of Phase 2a, evidence about the efficacy of existing treatments, and expert opinion regarding key safety criteria (Nixon et al, 2009).
In an evaluation of AZD9056 being developed by AstraZeneca, results showed that, depending on the design of the development programme, AZD9056 had probabilities of successful drug registration in the range 0.044–0.142 for an ACR20 outcome and 0.057–0.213 for an ACR50 outcome. Nonetheless, AZD9056 did proceed to Phase 2b and the results of an evaluation of four doses were recently published on the company’s clinical trials website (http://www.astrazenecaclinicaltrials.com/). Each of the AZD9056 treatment groups was similar to the placebo group in terms of the ACR20 response rates at week 24.
CHEBS is interested in hearing from companies that would like to collaborate in further applications of BCTS, including the development of linked economic models and formal updating methods. Contact John Stevens for further details.