open access

Vol 10, No 5 (2021)
Other materials agreed with the Editors
Submitted: 2021-01-07
Accepted: 2021-03-08
Published online: 2021-11-03
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A review on generation of real-world evidence

M Shunmugavelu1, Jayanta Ku. Panda2, Ashish Sehgal3, Brij Mohan Makkar4
DOI: 10.5603/DK.2021.0049
·
Clinical Diabetology 2021;10(5):412-419.
Affiliations
  1. Chairman, Trichy Diabetes Speciality Centre (P) Ltd, Trichy, Tamil Nadu, India
  2. SCB Medical College, India
  3. Diabetic Medicine, India
  4. Cleveland Clinic Advanced Certificate Courses in Diabetes, India

open access

Vol 10, No 5 (2021)
Original articles
Submitted: 2021-01-07
Accepted: 2021-03-08
Published online: 2021-11-03

Abstract

Real-world evidence can generate credible evidence to inform treatment decisions. Real-world evidence is in developmental stage and is fast evolving yet there are many unexplained attributes of real-world evidence. Real-world evidence informs benefit-risk decisions and is increasingly being used to support regulatory decision making. Potential benefits of real-world data include determination of extended outcomes including long-term outcomes, opportunities to partner with patients in innovative ways, and reduction in time and cost to generate dependable evidence. Limitations of real-world evidence include uncertainty in the quality of datasets and lack methodologic rigor in real-world studies. Use of real-world evidence for healthcare practices and policies is limited. Ensuring completeness, homogeneity, and linkage of datasets can enhance utility for epidemiological investigations and improvement in health outcomes. Research should be strengthened for real-world studies and technical standards should be reinforced. Collaborations of stakeholders is key to formulation and adoption of guidance for real-world evidence. Real-world data cannot be a substitute to randomized clinical studies but can possibly augment the generated evidence.

Abstract

Real-world evidence can generate credible evidence to inform treatment decisions. Real-world evidence is in developmental stage and is fast evolving yet there are many unexplained attributes of real-world evidence. Real-world evidence informs benefit-risk decisions and is increasingly being used to support regulatory decision making. Potential benefits of real-world data include determination of extended outcomes including long-term outcomes, opportunities to partner with patients in innovative ways, and reduction in time and cost to generate dependable evidence. Limitations of real-world evidence include uncertainty in the quality of datasets and lack methodologic rigor in real-world studies. Use of real-world evidence for healthcare practices and policies is limited. Ensuring completeness, homogeneity, and linkage of datasets can enhance utility for epidemiological investigations and improvement in health outcomes. Research should be strengthened for real-world studies and technical standards should be reinforced. Collaborations of stakeholders is key to formulation and adoption of guidance for real-world evidence. Real-world data cannot be a substitute to randomized clinical studies but can possibly augment the generated evidence.

Get Citation

Keywords

Real-world evidence; Healthcare policies; Real-world data; Pragmatic trials; Policy making

About this article
Title

A review on generation of real-world evidence

Journal

Clinical Diabetology

Issue

Vol 10, No 5 (2021)

Article type

Other materials agreed with the Editors

Pages

412-419

Published online

2021-11-03

Page views

2012

Article views/downloads

183

DOI

10.5603/DK.2021.0049

Bibliographic record

Clinical Diabetology 2021;10(5):412-419.

Keywords

Real-world evidence
Healthcare policies
Real-world data
Pragmatic trials
Policy making

Authors

M Shunmugavelu
Jayanta Ku. Panda
Ashish Sehgal
Brij Mohan Makkar

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