FDA Expands Collaboration to Predict Ongoing Phase IV Trial Outcomes Using Real-World Evidence for the First Time
Aetion
Healthcare Data Analytics Service Provider
Brigham and Women's Hospital
Brigham and Women's Hospital is the largest hospital in Boston, Massachusetts, USA. As the second-largest teaching affiliate of Harvard Medical School, it has 793 beds and, together with Massachusetts General Hospital, is one of the two founding members of Partners HealthCare, the largest healthcare provider in Massachusetts. It is composed of physicians, scientists, and healthcare professionals dedicated to patient care, biomedical research, education, and training programs. Furthermore, the hospital is committed to health equity and reducing disparities locally and globally through its numerous global health initiatives. It is recognized for its expertise in cardiac and vascular care, cancer care, orthopedics and arthritis treatment, neurology and neurosurgery, women's health, and nearly all other areas of adult medicine. The hospital is the second-largest recipient of National Institutes of Health (NIH) funding among U.S. hospitals and has achieved pioneering research and many firsts, including organ transplantation and mitral valve surgery. In addition to its modern inpatient facilities located in the heart of Boston's Longwood Medical Area, it provides seamless care through a vast network of outpatient services and clinics, community primary care centers, and state-of-the-art diagnostic and treatment centers worldwide, spanning 120 countries. This network includes 1,200 physicians working in 150 outpatient clinics across the New England region. As an international leader in various fields of medicine, Brigham and Women's Hospital has made significant breakthroughs in medicine and science, improving lives around the world. U.S. News & World Report has ranked Brigham and Women's Hospital among the best hospitals in many specialties, including cancer, cardiology and heart surgery, diabetes and endocrinology, ear, nose, and throat (ENT), gastroenterology and gastrointestinal surgery, geriatrics, gynecology, nephrology, neurology and neurosurgery, orthopedics, pulmonology, rheumatology, and urology.
FDA
U.S. Food and Drug Administration
Can Real-World Evidence (RWE) Replace Clinical Trials to Support Regulatory Approval by the U.S. FDA? The U.S. FDA, in collaboration with Brigham and Women’s Hospital of Harvard University and Aetion, Inc., will work to answer this question. Today, the U.S.FDAExpanded collaboration with Brigham and Women’s Hospital and Aetion, Inc. will use RWE to predict outcomes for seven ongoing Phase 4 clinical trials. This marks the first time researchers will use RWE to predict results of trials that have not yet concluded.Clinical TrialsResults.
RWE is inClinical TrialHealthcare data obtained from insurance claims, electronic health records, patient-reported outcomes, and other sources, outside of strictly controlled environments. Biopharmaceutical companies are increasingly using real-world evidence (RWE) for drug safety and efficacy analyses, and the FDA has recognized that such data may support regulatory decisions; therefore,FDA, Brigham and Women's Hospital, and Aetion, Inc. launched the RCT DUPLICATE project.
The initial goal of this project was to leverage real-world evidence (RWE) obtained from healthcare databases to replicate 30 completed Phase 3/4 trials.Clinical Trialsresults. The information obtained from this project can helpFDAEstablish standards for using real-world evidence (RWE) to inform regulatory decisions. For example, this project aims to identify the circumstances under which RWE derived from healthcare databases can accurately assess the safety and efficacy of specific therapies, thereby guiding the approval of supplemental new drug applications. Researchers will use Aetion’s proprietary Aetion Evidence Platform for data analysis.
It is worth mentioning that,FDARecently approved based on RWE,Pfizer(Pfizer) Company forBreast CancerThe supplemental Biologics License Application (sBLA) submitted for Ibrance therapy, approving it for the treatment of male breast cancer patients, demonstratedFDACommitment to Using RWE to Support Regulatory Decision-Making
To enhance the transparency of this project, researchers will register seven new studies on clinicaltrials.gov and allowFDAAble to oversee all steps and outcomes of the study. Interim results of this study will be available by mid-year, with full results expected by the end of 2020.
“Predicting trial results before the conclusion of a clinical trial is critically important, as it can demonstrate that, in certain circumstances, RWE can serve as a substitute forClinical Trials“,” said Dr. Jessica Franklin, Professor of Medicine at Harvard Medical School, biostatistician at Brigham and Women’s Hospital, and lead of the RCT DUPLICATE project: “This initiative will provide critical information to help us develop process models for conducting RWE studies that meet regulatory standards.”Bio ValleyBioon.com）