Although many CROs offer out­standing research capabilities, not every assessor or overreader receives sufficient instruction to reduce variability and error. To avoid multimillion-dollar misfor­tunes, sponsors should prioritize assessor and overreader education to improve data quality.

1. Site evaluators or assessors must receive protocol training to reduce variability amongst data collection personnel. This should highlight: study endpoints, enrollment criteria and demo­graphic requirements; patient preparation to be completed before acquiring data points; equipment operation procedures for consistent data collection and entry; the laboratory’s data acquisition standards, including patient-specific lead placement at each time point and expla­nations of protocol-required imaging sequences; and query resolution processes.
2. Overreading physicians must receive training prior to subject assessment to minimize inter- and intra-reader variability. Training should include: re­views of protocol design, pri­mary and secondary endpoints, time points and assessment criteria; an intracalibration session reviewing reading techniques, discussing scor­ing definitions and practicing reading case examples using central laboratory systems; an intercalibration session com­paring findings to one another and to diagnostic standards; individual review sessions to certify performance before reading study cases; periodic reviews to test for variability and recalibrate; and adjudica­tion procedures—some studies use multiple overreaders with an adjudicator.

Well-trained readers and as­sessors are essential to reducing clinical trials’ data variability. With the ever-increasing costs, complexity and number of clinical trials, sponsors must rigorously train CRO personnel to maximize drug approval chances.

Written by Guest Writer Joseph Pierro. Pierro is chief medical officer of Biomedical Systems, a premier global provider of centralized diagnostic services. He has served in global senior-level positions within the pharmaceutical industry and as a medical reviewer at the FDA Center for Drug Evaluation and Research. His thorough understanding of regulatory submission requirements and outstanding track record of success with regulatory approvals and responses to regulatory authorities make him an asset to Biomedical Systems’ Scientific Affairs team.

This article was reprinted from Volume 24, Issue 01, of The CenterWatch Monthly, an industry leading publication providing hard-hitting, authoritative business and financial coverage of the clinical research space. The Action Items section features short columns  focusing on actionable or how-to advice from clinical trial professionals. To submit an Action Item, please contact editorial@centerwatch.com. Subscribe >>