For insights into the real world, consider real-world data-Reference-Cited by-同舟云学术

For insights into the real world, consider real-world data

Published:2022-11-30 Issue:673 Volume:14 Page:
ISSN:1946-6234
Container-title:Science Translational Medicine
language:en
Short-container-title:Sci. Transl. Med.

Author:

Raoof Sana¹^ORCID,Kurzrock Razelle²³^ORCID

Affiliation:

1. Radiation Oncology, Memorial Sloan Kettering Cancer Center, New York, NY, USA.

2. Worldwide Innovative Network Consortium, Villejuif, France.

3. Medical College of Wisconsin, Milwaukee, WI, USA.

Abstract

Randomized control trials (RCTs) are required before drug and device approvals and have contributed to patient safety, but they have also increased the cost and time of regulatory assessments. We propose that using real-world evidence to complement or, in some settings, to replace RCTs will accelerate delivery of new drugs to patients.

Publisher

American Association for the Advancement of Science (AAAS)

Subject

General Medicine

Reference30 articles.

1. 21st Century Cures Act

2. Multidimensional Evidence Generation and FDA Regulatory Decision Making

3. Representation of Minorities and Women in Oncology Clinical Trials: Review of the Past 14 Years

4. The Evolution of Evidence-Based Medicine: When the Magic of the Randomized Clinical Trial Meets Real-World Data

5. Replication of Randomized, Controlled Trials Using Real-World Data: What Could Go Wrong?

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