Current Edition

Evolving Clinical Trial Landscape Requires Quality Focus

Striving to deliver the very best outcomes sits at the heart of clinical research. Arguably the mechanism for delivering that “perfect” outcome rests squarely on the shoulder of a single key principle – quality. Quality permeates all areas from study design to data collection, to successful publication, and many more. The idea of quality includes a vast array of perspectives gained from the evolution of trends in the development of quality management practices. For example, Good Clinical Practice (GCP) is regarded as the ethical and scientific quality standard for conducting a trial and applies to all steps in the process that combine for a successful trial conclusion. John Buchan at Pharmasol states, that the GCP role is to ensure that the clinical trial data and reported results are credible and accurate and that the rights, integrity, and confidentiality of the trial subjects are protected.