Quintiles' Real-World & Late Phase Research division leads AHRQ effort for evaluating patient outcomes since 2005.
Quintiles-Led Registries User’s Guide Published by AHRQ
Quintiles announced that the U.S. Agency for Healthcare Research and Quality (AHRQ) has published the third edition of “Registries for Evaluating Patient Outcomes: A User’s Guide.” Quintiles’ Real-World & Late Phase Research division has led this effort to create the patient registries reference since 2005. This publication provides a comprehensive guide to the design, operation, analysis and evaluation of patient registries. Nancy A. Dreyer, MPH, Ph.D., senior editor of the handbook and global chief of Scientific Affairs at Quintiles served as a senior editor for the project. In addition, Dr. Dreyer and Dr. Priscilla Velentgas, senior director of Epidemiology at Quintiles, are also senior editors of a second AHRQ User’s Guide, titled “Developing a Protocol for Observational Comparative Effectiveness Research.”
The third edition of the registries user’s guide was created in collaboration with more than 240 individuals, representing industry, academia, government and patients. In total, there were 100 chapter contributors, 76 invited peer reviewers, plus public comment, and 109 case example contributors, with some individuals participating in multiple ways. The 11 new chapters address challenges related to design, operations, ethics, analysis, and legal and technical concerns, with topics including:
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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.
Improving Engagement While Maintaining Data Integrity & Validity
March 19th 2024In recognition of Women's Health Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and uMotif's Chief Product Officer, Julia Lakeland, discuss new technologies improving patient engagement and reducing the emotional and logistical burdens of participation, ethical considerations that should be addressed when implementing those technologies, while ensuring patient privacy, and much more.
FDA Grants Ziftomenib with Breakthrough Therapy Designation for NPM1-Mutant Acute Myeloid Leukemia
April 23rd 2024Data from the Phase Ib portion of the KOMET-001 trial showed that the once-daily oral treatment may provide a substantial improvement over available therapies for relapsed/refractory NPM1-mutant acute myeloid leukemia.