Literature DB >> 33928789

Organized structure of real-world evidence best practices: moving from fragmented recommendations to comprehensive guidance.

Ashley Jaksa1, James Wu2, Páll Jónsson3, Hans-Georg Eichler4, Sarah Vititoe1, Nicolle M Gatto1.   

Abstract

Decision-makers have become increasingly interested in incorporating real-world evidence (RWE) into their decision-making process. Due to concerns regarding the reliability and quality of RWE, stakeholders have issued numerous recommendation documents to assist in setting RWE standards. The fragmented nature of these documents poses a challenge to researchers and decision-makers looking for guidance on what is 'high-quality' RWE and how it can be used in decision-making. We offer researchers and decision-makers a structure to organize the landscape of RWE recommendations and identify consensus and gaps in the current recommendations. To provide researchers with a much needed pathway for generating RWE, we discuss how decision-makers can move from fragmented recommendations to comprehensive guidance.

Keywords:  decision-making; health technology assessment; methodology; observational research; real-world evidence; regulatory approval

Year:  2021        PMID: 33928789     DOI: 10.2217/cer-2020-0228

Source DB:  PubMed          Journal:  J Comp Eff Res        ISSN: 2042-6305            Impact factor:   1.744


  4 in total

Review 1.  The value of anticancer drugs - a regulatory view.

Authors:  Francesco Pignatti; Ulla Wilking; Douwe Postmus; Nils Wilking; Julio Delgado; Jonas Bergh
Journal:  Nat Rev Clin Oncol       Date:  2021-12-06       Impact factor: 66.675

Review 2.  The Structured Process to Identify Fit-For-Purpose Data: A Data Feasibility Assessment Framework.

Authors:  Nicolle M Gatto; Ulka B Campbell; Emily Rubinstein; Ashley Jaksa; Pattra Mattox; Jingping Mo; Robert F Reynolds
Journal:  Clin Pharmacol Ther       Date:  2021-12-01       Impact factor: 6.903

3.  Treatment effectiveness in a rare oncology indication: Lessons from an external control cohort study.

Authors:  Dina Oksen; Patricia Prince; Emmanuelle Boutmy; Elizabeth M Garry; Barbara Ellers-Lenz; Adina Estrin; Andreas Johne; Patrice Verpillat; Nicolle M Gatto
Journal:  Clin Transl Sci       Date:  2022-06-11       Impact factor: 4.438

4.  Developing a real-world database for oncology: a descriptive analysis of breast cancer in Argentina.

Authors:  Guillermo Streich; Marcelo Blanco Villalba; Christian Cid; Guillermo F Bramuglia
Journal:  Ecancermedicalscience       Date:  2022-08-04
  4 in total

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