Finding better ways to measure subjective endpoints in clinical trials for central nervous system (CNS) diseases is the goal of a new US foundation that recently held its first meet in Washington, DC.

Governed by a council of experts in psychiatry and neurology, the Foundation for Improving Data Quality (FIDQ) will support objective, non-partisan applied research aimed at improving the validity, accuracy and reliability of data collection and assessment methodologies in fields such as psychiatry, neurology and pain that rely on subjective endpoints.

The longer-term objective is to improve the success rate of clinical trials in these areas. The subjective nature of clinician-rated and patient-reported outcomes “is associated with relatively high error variance in measurement, as compared to objective, physiologic measures”, noted Council member Dr John Greist from the Madison Institute of Medicine, University of Wisconsin, and Healthcare Technology Systems, Inc.

“This, in turn, may contribute to the high failure rate of clinical trials where reliance on non-physiologic for establishing efficacy is used,” Greist added. “By perfecting the precision of subjective measures, we hope to enhance statistical power and reduce sample size, while improving signal detection within clinical trials.”

Systematic development of reliable, valid and novel signal detection methodologies is “paramount” for the FIDQ, said another Council member, Dr David Daniel of United BioSource Corporation.

Chairman of the Council is Dr Amir Kalali, vice-president, medical and scientific services and global therapeutic group leader CNS for contract research organisation Quintiles Transnational Corporation. The other experts serving on the Council are all from academia.

The Foundation for Improving Data Quality is based in the Southeastern district of Pennsylvania.

In March United BioSource Corporation, which is a US-based pharmaceutical services organisation, formed a European Advisory Board for Data Quality in an effort to improve ratings quality and outcomes in clinical trials of CNS drugs.