Advancing a Framework for Regulatory Use of Real-World Evidence: When Real Is Reliable
Open Access
- 1 May 2018
- journal article
- research article
- Published by Springer Nature in Therapeutic Innovation & Regulatory Science
- Vol. 52 (3) , 362-368
Abstract
There is growing interest in regulatory use of randomized pragmatic trials and noninterventional real-world (RW) studies of effectiveness and safety, but tKeywords
This publication has 17 references indexed in Scilit:
- Evidence generation from healthcare databases: recommendations for managing changePharmacoepidemiology and Drug Safety, 2016
- The Salford Lung Study protocol: a pragmatic, randomised phase III real-world effectiveness trial in asthmaBMC Pulmonary Medicine, 2015
- A Randomized Trial of Intensive versus Standard Blood-Pressure ControlNew England Journal of Medicine, 2015
- The Food and Drug Administration and pragmatic clinical trials of marketed medical productsClinical Trials, 2015
- Obtaining real-world evidence: the Salford Lung StudyThorax, 2014
- The GRACE Checklist for Rating the Quality of Observational Studies of Comparative Effectiveness: A Tale of Hope and CautionJournal of Managed Care Pharmacy, 2014
- Use of Medicare Data to Identify Coronary Heart Disease Outcomes in the Women’s Health InitiativeCirculation: Cardiovascular Quality and Outcomes, 2014
- Drug Policy for an Aging Population — The European Medicines Agency's Geriatric Medicines StrategyNew England Journal of Medicine, 2012
- An Overview of Endpoints for Cystic Fibrosis Clinical Trials: One Size Does Not Fit AllProceedings of the American Thoracic Society, 2007
- No Adjustments Are Needed for Multiple ComparisonsEpidemiology, 1990