Quintiles today announced that it has received a research award from the Patient-Centered Outcomes Research Institute (PCORI) to compare the effectiveness of treatments for uterine fibroids, a common condition affecting women of childbearing age. The study is part of a portfolio of patient-centered research that addresses PCORI’s national research priorities. It will provide patients and their caregivers with information that will help them make better-informed care decisions.
“More than $4 billion is spent annually to treat uterine fibroids in the United States[1], yet there is little scientific evidence about which treatment options are better than others. The clinical community needs better data to demonstrate the effectiveness, quality and value of treatments in real-world clinical practice,” said Richard Gliklich, MD, President, Quintiles Outcome, the real-world and late phase division of Quintiles. “With this research award we will compare patient outcomes after a variety of treatments, developing high-quality and clinically rich patient-level data to inform better care decisions.”
The research will be led by Dr. Gliklich and be supported by Penny Mohr, MA, Vice President of Program Development at the Center for Medical Technology Policy, and Evan Myers, MD, MPH, Walter M. Thomas Distinguished Professor in the Department of Obstetrics and Gynecology at Duke University. The investigators will take a comprehensive approach to evidence development, analyzing more than 33,000 patient records from electronic medical records, claims data and data from integrated healthcare delivery systems. The primary objective of the study is to answer critical questions prioritized by multiple stakeholders such as how long treatment effects (that is, relief from symptoms) last for treatments other than hysterectomy, as well as for all treatments, including hysterectomy.
“This project reflects PCORI’s commitment to support patient-centered comparative effectiveness research, a new approach to health research that emphasizes the inclusion of patients and caregivers at all stages of the study process,” said PCORI Executive Director Joe Selby, MD, MPH. “The research will provide patients and those who care for them with better information about the healthcare decisions they face.”
The Quintiles study was selected through a highly competitive review process in which scientists, patients, caregivers, and other stakeholders helped to evaluate more than 400 applications for funding. Proposals were evaluated on the basis of scientific merit, how well they engage patients and other stakeholders, their methodological rigor, and how well they fit within PCORI’s national research priorities.
The awards are part of PCORI’s second cycle of primary research funding totaling $88.6 million. This new round of funding follows PCORI’s initial approval of $40.7 million in support for 25 projects under the institute’s national research priorities. All awards in this most recent round of funding were approved pending completion of a business and programmatic review by PCORI staff and issuance of a formal award contract. For more information about PCORI’s Funding Announcements, visit www.pcori.org/funding-opportunities.
AI in Clinical Trials: A Long, But Promising Road Ahead
May 29th 2024Stephen Pyke, chief clinical data and digital officer, Parexel, discusses how AI can be used in clinical trials to streamline operational processes, the importance of collaboration and data sharing in advancing the use of technology, and more.
Including Women of Childbearing Age in Clinical Research
March 26th 2024In recognition of International Women's Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and Marie Teil, Global Head of UCB’s Women of Childbearing Age Program. They speak about the specific challenges women with chronic illnesses face when accessing appropriate treatment and participating in clinical trials, UCB's Women of Childbearing Age Program and it’s most successful strategies, and much more.