Literature DB >> 32632753

Bridging the Gap Between RCTs and RWE Through Endpoint Selection.

Robert J LoCasale1, Chris L Pashos2, Ben Gutierrez3, Nancy A Dreyer4, Toby Collins5, Alan Calleja5, Michael J Seewald6, Jonathan M Plumb7, Johan Liwing8, Maurille Feudjo Tepie9, Sajan Khosla10.   

Abstract

This commentary is authored by several industry real-world evidence (RWE) experts, with support from IQVIA, as part of the 'RWE Leadership Forum': a group of Industry Leaders who have come together as non-competitive partners to understand and respond to RWD/E challenges and opportunities with a single expert voice. Here, the forum discusses the value in bridging the industry disconnect between RTCs and RWE, with a view to promoting the use of RWE in the RCT environment. RCT endpoints are explored along several axes including their clinical relevance and their measure of direct patient benefit, and then compared with their real-world counterparts to identify suitable paths, or gaps, for assimilating RWE endpoints into the RCT environment.

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Year:  2020        PMID: 32632753      PMCID: PMC7785541          DOI: 10.1007/s43441-020-00193-5

Source DB:  PubMed          Journal:  Ther Innov Regul Sci        ISSN: 2168-4790            Impact factor:   1.778


  6 in total

1.  Correction to: Bridging the Gap Between RCTs and RWE Through Endpoint Selection.

Authors:  Robert J LoCasale; Chris L Pashos; Ben Gutierrez; Nancy A Dreyer; Toby Collins; Alan Calleja; Michael J Seewald; Jonathan M Plumb; Johan Liwing; Maurille Feudjo Tepie; Sajan Khosla
Journal:  Ther Innov Regul Sci       Date:  2021-01       Impact factor: 1.778

2.  Discordance between ICD-Coded Myocardial Infarction and Diagnosis according to the Universal Definition of Myocardial Infarction.

Authors:  Jorge Díaz-Garzón; Yader Sandoval; Stephen W Smith; Sara Love; Karen Schulz; Sarah E Thordsen; Benjamin K Johnson; Brian Driver; Katherine Jacoby; Michelle D Carlson; Kenneth W Dodd; Johanna Moore; Nathaniel L Scott; Charles A Bruen; Ryan Hatch; Fred S Apple
Journal:  Clin Chem       Date:  2016-11-03       Impact factor: 8.327

3.  Asking the right questions to get the right answers: using cognitive interviews to review the acceptability, comprehension and clinical meaningfulness of patient self-report adverse event items in oncology patients.

Authors:  Patricia Holch; Lorraine Warrington; Barbara Potrata; Lucy Ziegler; Ceri Hector; Ada Keding; Clare Harley; Kate Absolom; Carolyn Morris; Leon Bamforth; Galina Velikova
Journal:  Acta Oncol       Date:  2016-08-23       Impact factor: 4.089

4.  Real-world Evidence versus Randomized Controlled Trial: Clinical Research Based on Electronic Medical Records.

Authors:  Hun-Sung Kim; Suehyun Lee; Ju Han Kim
Journal:  J Korean Med Sci       Date:  2018-06-26       Impact factor: 2.153

5.  Generating Real-World Tumor Burden Endpoints from Electronic Health Record Data: Comparison of RECIST, Radiology-Anchored, and Clinician-Anchored Approaches for Abstracting Real-World Progression in Non-Small Cell Lung Cancer.

Authors:  Sandra D Griffith; Melisa Tucker; Bryan Bowser; Geoffrey Calkins; Che-Hsu Joe Chang; Ellie Guardino; Sean Khozin; Josh Kraut; Paul You; Deb Schrag; Rebecca A Miksad
Journal:  Adv Ther       Date:  2019-05-28       Impact factor: 3.845

Review 6.  Trial designs using real-world data: The changing landscape of the regulatory approval process.

Authors:  Elodie Baumfeld Andre; Robert Reynolds; Patrick Caubel; Laurent Azoulay; Nancy A Dreyer
Journal:  Pharmacoepidemiol Drug Saf       Date:  2019-12-10       Impact factor: 2.890

  6 in total
  2 in total

1.  Real World Evidence in Medical Cannabis Research.

Authors:  Rishi Banerjee; Simon Erridge; Oliver Salazar; Nagina Mangal; Daniel Couch; Barbara Pacchetti; Mikael Hans Sodergren
Journal:  Ther Innov Regul Sci       Date:  2021-11-08       Impact factor: 1.778

Review 2.  Use of Real-World Evidence to Drive Drug Development Strategy and Inform Clinical Trial Design.

Authors:  Simon Dagenais; Leo Russo; Ann Madsen; Jen Webster; Lauren Becnel
Journal:  Clin Pharmacol Ther       Date:  2021-11-28       Impact factor: 6.903

  2 in total

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