Background

The GRACE initiative has been launched to develop good practice principles for observational studies of comparative effectiveness through collaboration of knowledgeable people from academia, government, and the private sector. The goal of these principles is to enhance quality and facilitate the use of observational research to support decision-making by patients, physicians, and payers.

A key part of the GRACE initiative is creating a web-based, freely accessible library of real-world case studies that illustrate how observational comparative effectiveness studies can be used to support decision-making for product access, formulary placement, treatment guidelines or any other significant decisions relating to approval for payments or adopting use. The library will include a concise description of the study, a discussion of how it was used for decision-making, and the contributor’s view on what features made the study strong enough to support decision-making.

The cases are classified by drug, device, and biologics or vaccine, with icons representing the different types of decision-making that require evidence from observational studies.

Case Studies

Drug
Expanded Indication for Clozapine
Pregnancy Outcomes Following Systemic Prenatal Acyclovir Exposure: Conclusions from the International Acyclovir Pregnancy Registry, 1984-1999
Device
Expanded Medicare Coverage for FDG-PET and Cancers with the National Oncologic PET Registry (NOPR)
Biologic and Vaccines
Effect of Introduction of the Pneumococcal Conjugate Vaccine on Drug-Resistant Streptococcus Pneumoniae (SP)