Biological therapies need definitive randomized controlled clinical trials

Author:

Califf Robert M.ORCID,Marks Peter W.ORCID

Abstract

Adequate and well-controlled clinical trials remain critical tools for helping to bring benefit to patients in medical need.

Publisher

American Association for the Advancement of Science (AAAS)

Subject

General Medicine

Reference8 articles.

1. Long-term benefit of Microbiota Transfer Therapy on autism symptoms and gut microbiota

2. Treating Clostridium difficile Infection With Fecal Microbiota Transplantation

3. Randomised controlled trials - the gold standard for effectiveness research

4. Randomization—There Is No Substitute

5. U.S. Food and Drug Administration Guidance for Industry: Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products. December 2019 www.fda.gov/regulatory-information/search-fda-guidance-documents/demonstrating-substantial-evidence-effectiveness-human-drug-and-biological-products [accessed 21 June 2022].

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