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Literature DB >> 30100687

Real-World Evidence: Promise and Peril For Medical Product Evaluation.

Sanket S Dhruva, Joseph S Ross, Nihar R Desai.

Abstract

Randomized controlled trials have long been the gold standard for evidence in medical product evaluation, but there is growing support for the use of real-world evidence (RWE). The authors review the benefits and limitations of RWE and discuss the implications for P&T committees.

Year: 2018 PMID： 30100687 PMCID： PMC6065494

Source DB: PubMed Journal: P T ISSN： 1052-1372

60 in total

1. Regulatory watch: Characterizing the US FDA's approach to promoting transformative innovation.

Authors: Nicholas S Downing; Harlan M Krumholz; Joseph S Ross; Nilay D Shah
Journal: Nat Rev Drug Discov Date: 2015-10-05 Impact factor: 84.694

2. Paying for Prevention: A Novel Test of Medicare Value-Based Payment for Cardiovascular Risk Reduction.

Authors: Darshak M Sanghavi; Patrick H Conway
Journal: JAMA Date: 2015-07-14 Impact factor: 56.272

Review 3. An FDA Viewpoint on Unique Considerations for Medical-Device Clinical Trials.

Authors: Owen Faris; Jeffrey Shuren
Journal: N Engl J Med Date: 2017-04-06 Impact factor: 91.245

4. Research and Development Spending to Bring a Single Cancer Drug to Market and Revenues After Approval.

Authors: Vinay Prasad; Sham Mailankody
Journal: JAMA Intern Med Date: 2017-11-01 Impact factor: 21.873

5. Merits of Data Sharing: The Digitalis Investigation Group Trial.

Authors: Suveen Angraal; Joseph S Ross; Sanket S Dhruva; Nihar R Desai; John W Welsh; Harlan M Krumholz
Journal: J Am Coll Cardiol Date: 2017-10-03 Impact factor: 24.094

6. Full coverage for preventive medications after myocardial infarction.

Authors: Niteesh K Choudhry; Jerry Avorn; Robert J Glynn; Elliott M Antman; Sebastian Schneeweiss; Michele Toscano; Lonny Reisman; Joaquim Fernandes; Claire Spettell; Joy L Lee; Raisa Levin; Troyen Brennan; William H Shrank
Journal: N Engl J Med Date: 2011-11-14 Impact factor: 91.245

7. Automated surveillance to detect postprocedure safety signals of approved cardiovascular devices.

Authors: Frederic S Resnic; Thomas P Gross; Danica Marinac-Dabic; Nilsa Loyo-Berrios; Sharon Donnelly; Sharon-Lise T Normand; Michael E Matheny
Journal: JAMA Date: 2010-11-10 Impact factor: 56.272

8. Participation in cancer clinical trials: race-, sex-, and age-based disparities.

Authors: Vivek H Murthy; Harlan M Krumholz; Cary P Gross
Journal: JAMA Date: 2004-06-09 Impact factor: 56.272

9. Pragmatic Trials.

Authors: Ian Ford; John Norrie
Journal: N Engl J Med Date: 2016-08-04 Impact factor: 91.245

10. Launching PCORnet, a national patient-centered clinical research network.

Authors: Rachael L Fleurence; Lesley H Curtis; Robert M Califf; Richard Platt; Joe V Selby; Jeffrey S Brown
Journal: J Am Med Inform Assoc Date: 2014-05-12 Impact factor: 4.497

14 in total

1. Aggregating multiple real-world data sources using a patient-centered health-data-sharing platform.

Authors: Sanket S Dhruva; Joseph S Ross; Joseph G Akar; Brittany Caldwell; Karla Childers; Wing Chow; Laura Ciaccio; Paul Coplan; Jun Dong; Hayley J Dykhoff; Stephen Johnston; Todd Kellogg; Cynthia Long; Peter A Noseworthy; Kurt Roberts; Anindita Saha; Andrew Yoo; Nilay D Shah
Journal: NPJ Digit Med Date: 2020-04-20

2. Experts' Views on FDA Regulatory Standards for Drug and High-Risk Medical Devices: Implications for Patient Care.

Authors: Sanket S Dhruva; Jonathan J Darrow; Aaron S Kesselheim; Rita F Redberg
Journal: J Gen Intern Med Date: 2022-02-09 Impact factor: 5.128

3. Use of Real-World Data and Evidence in Drug Development of Medicinal Products Centrally Authorized in Europe in 2018-2019.

Authors: Sini Marika Eskola; Hubertus Gerardus Maria Leufkens; Andrew Bate; Marie Louise De Bruin; Helga Gardarsdottir
Journal: Clin Pharmacol Ther Date: 2021-11-16 Impact factor: 6.903

4. Feasibility of Using Real-World Data to Replicate Clinical Trial Evidence.

Authors: Victoria L Bartlett; Sanket S Dhruva; Nilay D Shah; Patrick Ryan; Joseph S Ross
Journal: JAMA Netw Open Date: 2019-10-02

5. Aggregating multiple real-world data sources using a patient-centered health-data-sharing platform.

6. RWE Framework: An Interactive Visual Tool to Support a Real-World Evidence Study Design.

Authors: Andrew D Xia; Caroline P Schaefer; Agota Szende; Elke Jahn; Matthew J Hirst
Journal: Drugs Real World Outcomes Date: 2019-12

Review 7. Real-world evidence and product development: Opportunities, challenges and risk mitigation.

Authors: Poobalan Naidoo; Célia Bouharati; Virendra Rambiritch; Nadina Jose; Sumanth Karamchand; Robert Chilton; Rory Leisegang
Journal: Wien Klin Wochenschr Date: 2021-04-09 Impact factor: 1.704

8. Improving Mental Health Services: A 50-Year Journey from Randomized Experiments to Artificial Intelligence and Precision Mental Health.

Authors: Leonard Bickman
Journal: Adm Policy Ment Health Date: 2020-09

9. Attribution of Adverse Events Following Coronary Stent Placement Identified Using Administrative Claims Data.

Authors: Sanket S Dhruva; Craig S Parzynski; Ginger M Gamble; Jeptha P Curtis; Nihar R Desai; Robert W Yeh; Frederick A Masoudi; Richard Kuntz; Richard E Shaw; Danica Marinac-Dabic; Art Sedrakyan; Sharon-Lise T Normand; Harlan M Krumholz; Joseph S Ross
Journal: J Am Heart Assoc Date: 2020-02-16 Impact factor: 5.501

10. Clinical evaluation and diagnostic yield following evaluation of abnormal pulse detected using Apple Watch.

Authors: Kirk D Wyatt; Lisa R Poole; Aidan F Mullan; Stephen L Kopecky; Heather A Heaton
Journal: J Am Med Inform Assoc Date: 2020-07-01 Impact factor: 4.497