NEW YORK – August 27, 2018 – Aetion®, the software platform company delivering the real-world analytics and evidence needed for biopharma and payers to engage in value-based care, today announced that Brigham and Women’s Hospital (BWH) and Harvard Medical School (HMS) selected the Aetion Evidence Platform™ to support their work on the REPEAT program. The REPEAT program focuses on quantifying the current state of transparency in health care database studies and developing guidance so that decision-makers are better able to evaluate evidence from real-world data and drive better health care decisions.
This collaboration builds on Aetion’s existing partnership with BWH, HMS, and the U.S. Food & Drug Administration (FDA) to integrate real-world evidence into regulatory decision-making.
“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,” said Shirley Wang, PhD, director of the REPEAT program and assistant professor of medicine at HMS. “Our project involves replication of 150 published real-world data studies and implementation of hundreds of sub-analyses across multiple data assets. This is evidence generation at an unprecedented scale, and Aetion’s platform is critical to the success of our work.”
Through REPEAT (which stands for “Reproducible Evidence: Practices to Enhance and Achieve Transparency”), researchers are using Aetion’s scientifically validated platform to replicate and evaluate the robustness of a large sample of published health care database studies. The purpose of this research is to increase decision-makers’ confidence in using evidence from health care databases by setting standards on how to transparently report on study implementation to facilitate replicable findings — a key part of the scientific method.
“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,” said Jeremy Rassen, ScD, co-founder, president, and chief science officer at Aetion. “The REPEAT program is aimed at progressing standards for the use of real-world evidence, employing the Aetion Evidence Platform to conduct meta-research, or ‘research about how to do research,’ in order to evaluate what information could increase the use of real-world data for decision-making.”
As part of its work to develop standards for real-world evidence that result in more effective treatments and faster implementation, REPEAT is guided by a scientific advisory board with representatives from regulatory agencies including the FDA, European Medicines Agency, and the Pharmaceuticals & Medical Devices Agency of Japan, as well as participants from academia, medical journals, public and commercial health plans, and the biopharma industry.
Dr. Wang presented interim results from REPEAT at the 34th International Conference on Pharmacoepidemiology & Therapeutic Risk Management. There, she discussed the state of current health care database studies and progress to date on using the Aetion Evidence Platform to replicate the first 56 of the targeted 150 studies.
Dr. Wang presented preliminary data points in which a lack of transparency is most consequential. She spoke to 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. For example, while outcome codes are frequently provided in detail, authors rarely provide algorithms for study exclusion criteria — and without clarity on the exclusion criteria, it is difficult to replicate the study population used to generate the original findings.
The program is now evaluating the robustness of evidence found in health care database studies and checking for appropriate research design and analysis. Final results are anticipated in late 2019.
The Aetion Evidence Platform can analyze virtually any source of real-world data to determine medical need, comparative effectiveness, and the overall value profile of medical treatments and interventions. The platform is separately being used in a large-scale FDA-sponsored study to replicate the results of 30 published randomized controlled trials. Coupled with REPEAT, the FDA study aims to validate whether the use of real-world evidence leads to the same regulatory decisions as randomized controlled trials and to demonstrate whether this evidence could be used to supplement or, in certain circumstances, even replace clinical trials for drug development and regulatory approval.
Based in New York City, Aetion is a leading health care technology company that delivers the real-world analytics and evidence needed for pharmaceutical developers and purchasers to thrive in value-based care. With its patented rapid-cycle analytics technology, the Aetion Evidence Platform uses the everyday clinical and financial interactions of the health care system to unlock essential evidence about the effectiveness and value of medical treatments. Founded by Harvard Medical School faculty members and a big data pioneer, Aetion enables biopharma companies and payers to collaborate in real-time to develop therapeutic insights so patients get the most clinically effective — and cost-effective — care. Learn more at www.aetion.com.