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Randomized controlled trial

Flowchart of four phases (enrollment, allocation, intervention, follow-up, and data analysis) of a parallel randomized trial of two groups (in a controlled trial, one of the interventions serves as the control), modified from the CONSORT (Consolidated Standards of Reporting Trials) 2010 Statement[1]

A randomized controlled trial (or randomized control trial;[2] RCT) is a form of scientific experiment used to control factors not under direct experimental control. Examples of RCTs are clinical trials that compare the effects of drugs, surgical techniques, medical devices, diagnostic procedures, diets or other medical treatments.[3][4]

Participants who enroll in RCTs differ from one another in known and unknown ways that can influence study outcomes, and yet cannot be directly controlled. By randomly allocating participants among compared treatments, an RCT enables statistical control over these influences. Provided it is designed well, conducted properly, and enrolls enough participants, an RCT may achieve sufficient control over these confounding factors to deliver a useful comparison of the treatments studied.

  1. ^ Schulz KF, Altman DG, Moher D, et al. (CONSORT Group) (March 2010). "CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials". BMJ. 340: c332. doi:10.1136/bmj.c332. PMC 2844940. PMID 20332509.
  2. ^ Chalmers TC, Smith H, Blackburn B, et al. (May 1981). "A method for assessing the quality of a randomized control trial". Controlled Clinical Trials. 2 (1): 31–49. doi:10.1016/0197-2456(81)90056-8. PMID 7261638.
  3. ^ "What Are Clinical Trials and Studies?". National Institute on Aging, US National Institutes of Health. 22 March 2023. Retrieved 9 March 2024.
  4. ^ "What Are the Different Types of Clinical Research?". US Food and Drug Administration. 4 January 2018. Retrieved 9 March 2024.

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