Software platform developer Aetion said today that its Aetion Evidence PlatformTM will be used by Brigham and Women's Hospital (BWH) and Harvard Medical School (HMS) to support their REPEAT program, aimed at helping the institutions better evaluate evidence from real-world data.
REPEAT—which stands for “Reproducible Evidence: Practices to Enhance and Achieve Transparency"—aims to replicate and evaluate 150 published real-world data studies, as well as implement hundreds of sub-analyses across multiple data assets. The program aims to develop standards that improve the conduct and quality of real-world evidence, with the goal developing more effective treatments that reach the market more quickly.
“Today, data from real-world health care databases are not as broadly employed among regulators and payers as data from randomized controlled trials, leaving a vast opportunity to use this real-world evidence to inform decisions that impact patients,” Jeremy Rassen, Sc.D., Aetion’s co-founder, president, and CSO, said in a company statement.
REPEAT is designed to enhance the confidence of healthcare decisionmakers in using evidence from health care databases by setting standards on how to transparently report on study implementation to facilitate replicable findings.
“This is evidence generation at an unprecedented scale, and Aetion's platform is critical to the success of our work,” added Shirley Wang, Ph.D., director of the REPEAT program and assistant professor of medicine at HMS. “We chose Aetion because we needed an extensively validated, highly efficient, and fully transparent analytics solution with the flexibility to implement a wide range of real-world data analyses.”
Dr. Wang presented interim results from REPEAT at the 34th International Conference on Pharmacoepidemiology (ICPE) & Therapeutic Risk Management, held August 22-26 in Prague, Cech Republic, during a discussion of the state of current health care database studies in which she reported progress to date on using the Aetion Evidence Platform to replicate the first 56 of the targeted 150 studies.
REPEAT is now evaluating the robustness of evidence found in health care database studies and checking for appropriate research design and analysis, with final results anticipated in late 2019.
According to Aetion, Dr. Wang spoke at ICPE about efforts to discern the temporality of when parameters like exclusion criteria, covariates, outcomes, and follow-up are measured relative to study entry from what is often unclear in publication and sometimes results in substantially different findings. She offered an example: While outcome codes are frequently provided in detail, authors rarely provide algorithms for study exclusion criteria.
REPEAT is guided by a scientific advisory board with representatives from the FDA and other regulatory agencies, including the European Medicines Agency, and the Pharmaceuticals & Medical Devices Agency of Japan. Also on the board are participants from academia, medical journals, public and commercial health plans, and the biopharma industry.
Aetion said the partnership will build on a collaboration launched in May by the company, HMS, BWH, and the FDA. The partners agreed to use Aetion’s platform to replicate the results of 30 clinical trials using real-world evidence, with the goal of demonstrating the value of that evidence in speeding up the agency’s reviews and decisions on new drugs, especially for supplemental indications.
The FDA’s participation follows enactment in December 2016 of the 21st Century Cures Act and Prescription Drug User Fee Act VI. The law in part requires the FDA to develop guidance on how to integrate real-world evidence into its regulatory decision-making.