Effective Drug Supply for Adaptive Clinical Trials: Recommendations by the DIA Adaptive Design Scientific Working Group Drug Supply Subteam.

During the past decade, there has been increasing interest in adaptive clinical trials in pharmaceutical drug development as a means to improved decision making, better dose selection, and reduction in cost and time to market. Nevertheless, the operational challenge of drug supply continues to be a barrier preventing greater uptake of adaptive designs. Such studies require the ability to quickly accommodate changes in treatment allocation while maintaining the integrity of the blind.

Barriers and opportunities for implementation of adaptive designs in pharmaceutical product development.

Background: This review discusses barriers to implementing adaptive designs in a pharmaceutical R&D environment and provides recommendations on how to overcome challenges. A summary of findings from a survey conducted through PhRMA's working group on adaptive designs is followed by a report based on our experience as statistical and clinical consultants to project teams charged with establishing the clinical development strategy for investigational compounds and interested in applying innovative approaches.

Findings And Recommendations: Adaptive designs require additional work in that clinical trial simulations are needed to develop the design.

Irritable bowel syndrome: more than abdominal pain and bowel habit abnormalities.

Background & Aims: Although irritable bowel syndrome (IBS) can be defined using few symptoms, principal symptoms alone may be inadequate in monitoring disorder severity. Secondary analysis of a published data set was performed to determine if more inclusive symptom measures would better reflect the burden of this disorder.

Methods: From a prospective naturalistic study of 213 patients meeting Rome II criteria, all the data were used from daily questionnaires recorded for 4 weeks, and repeated again after an interval of 4 weeks.