The Good ReseArch for Comparative Effectiveness (GRACE) checklist is a simple 11-item tool that considers the study purpose and provides questions to guide high-level evaluation of methods, data quality and analytics for use in health technology assessments of effectiveness and safety studies. It provides a scoring tool to help evaluate studies in the context of the study goal, and can be used by sophisticated and less experienced users.

This tool stands out from other expert, consensus-driven guidance documents due to recent work that tested its ability to discriminate “good enough” from “not good enough” by examining studies that had been assembled for systematic reviews. Published listings of all the studies included in systematic reviews were examined and classified according to which studies expert reviewers considered good enough to be relied on for decision-making, and which were not. While that might not be the perfect gold standard, it took advantage of tremendous amounts of work that were already done, and were accessible and evaluable.

The single best predictors of quality included: use of concurrent comparators; limiting drug studies to new initiators of the study product; using equivalent measurement of outcomes in study groups; collecting data on most if not all known confounders or effect modifiers; accounting for immortal time bias in the analysis; and using sensitivity analyses to quantify the impact of bias by showing how much effect estimates depend on various assumptions.

Using the GRACE checklist, studies can be evaluated to determine whether they were rigorous enough for the study purpose. The EMA and NICE, the U.K.’s payer, agree, and both cite GRACE as valuable tools. The GRACE checklist was also recently chosen as the reporting standard for observational studies of comparative effectiveness by the Journal of Managed Care and Specialty Pharmacy.

Looking ahead, the GRACE checklist has promise to shape better conduct of observational studies of comparative effectiveness and enable their widespread use for decision support. www.graceprinciples.org

Guest Contributor Nancy Dreyer, Ph.D., MPH, FISPE, FDIA, is Global Chief of Scientific Affairs for QuintilesIMS' Real-World Insights. She leads an international team in the design, conduct and interpretation of real-world health research, including comparative effectiveness and safety, as well as injury prevention in professional sports.

This article was reprinted from Volume 24, Issue 10, 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 >>