With 225 projects in development across 17 therapeutic areas, Pfizer Global Research & Development conducts hundreds of clinical trials every year. Increasing clinical trial efficiency is a component of Pfizer’s quest to identify the most promising drugs early and speed drugs to patients.

The relationship with Cytel also brings training and consulting on flexible clinical trials to Pfizer sites worldwide. Pfizer and Cytel seek to equip Pfizer’s clinical biostatisticians with the know-how, the software, and the support to make the most of every clinical trial.

Cytel’s East software makes it easier for biostatisticians to explore many different design scenarios, and to communicate these ideas to their clinician colleagues. Having the right tools and skills to implement flexible clinical trial designs will help sponsor companies conduct clinical trials in the most efficient way possible. This will lead to cost savings, more effective use of scarce resources, and earlier go/no go decisions.

“We are very pleased to have Pfizer as a client in this important initiative in efficient clinical trial design,” said Dr. Cyrus Mehta, Chairman, Cytel Inc.. “Pfizer has a long history of innovation in clinical research. Their leadership in implementing flexible clinical trials will be beneficial to everyone seeking to bring effective therapies to market sooner.”

About Flexible Clinical Trials and East
Traditional clinical trial designs specify one efficacy analysis only at the end of the study, after all the study data have been collected. Flexible trials use group sequential or adaptive methods to monitor the accruing data at interim time points. Data from these interim analyses may be used to make important decisions concerning the future course of the study or program. It is also possible to discover and correct errors in trial design, which if not addressed could lead to an inconclusive study. Benefits include reaching go/no go decisions sooner, lower clinical development costs, and faster time to market.

There is much that sponsors can gain from conducting studies in more flexible ways. However, flexible designs should not be undertaken naively; they require sophisticated statistical methods. East helps sponsors take advantage of flexible designs, without jeopardizing the statistical validity of the studies. East is fully validated, and studies designed and monitored with East have won approval from the Food and Drug Administration and the EMEA.