What are randomized controlled trials?

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Key Points

• Randomized Controlled Trials (RCTs) are a type of study design commonly used in health research to explore the efficacy of interventions.
• The goal of an RCT is to increase the validity of experimental results and strengthen the evidence for causal relationships.
• RCTs use randomization, control groups, and blinding to control for variables and limit biases.

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Helpful Links, Videos and Online Courses

Overview

• Randomized Controlled Trial
  • An introduction to RCTs, including a step-by-step outline for how to design an RCT. Includes examples and tips in practice.

Videos

• Randomized Controlled Trials (RCTs)
  • A video from UNICEF that highlights the importance of control groups in Randomized Controlled Trials, different RCT designs (including factorial, cluster, and multifactorial designs), and pitfalls to avoid in sampling procedures.
• How do we know if an intervention works?
  • A 5-minute video describing how RCTs can be used to minimize bias and increase the validity of experimental findings, in terms of control groups and blinding.

Online Courses

• Randomized Controlled Trials
  • A 30-minute video lecture on statistical interventions and methods commonly used in RCTs.
  • Note: the video refers to a textbook, but the video is helpful even without the textbook.

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Relevant Publications

• Stanley, K. (2007). Design of Randomized Controlled Trials. Circulation, 115(9), 1164–1169.
  • A comprehensive article from 2007 describing elements of RCT design, especially for clinical trials and health research

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What is experimental research?

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Key Points

• An experimental (or intervention) study is a study where the exposure or treatment is controlled by the investigator.
• Experimental studies provide evidence to support or refute the existence of a cause-effect relationship.
• There are different types of experimental study designs.  One is the randomized controlled trial (RCT) which is considered the “gold standard” of experimental studies.

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Helpful Links, Videos and Online Courses

Overview

• Observational vs. Experimental Studies
  • Brief overview comparing observational and experimental research designs.
• Experimental Studies
  • Chapter 9 of Epidemiology for the Uninitiated published by BMJ.

Videos

• Experimental Study Designs: Clinical Trials
  • 19-minute overview video developed by the Indian Council of Medical Research.
• Randomized Controlled Trials (RCT)
  • 9-minute video developed by UNICEF Office of Research-Innocenti.
• Types of Experimental Designs
  • A 7-minute video detailing 3 types of experimental designs.

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Relevant Publications

• Bhide, A., Shah, P. S., & Acharya, G. (2018). A simplified guide to randomized controlled trials. Acta Obstetricia et Gynecologica Scandinavica, 97(4), 380–387.

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What are clinical trials and why are they important?

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Key Points

• Clinical trials can be experimental or observational research studies, depending on the research question.
• Clinical trials are commonly done to evaluate the safety, efficacy, and outcomes of newer treatments/medications on human health.
• They provide robust evidence for the safety and efficacy of newer treatments and drugs and maybe a single-center, multicenter or international study.

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Helpful Links, Videos and Online Courses

Overview

• What Are Clinical Trials and Studies? 
• Clinical Trials: A Guide
• Phases of Clinical Trials

Videos

• Understanding Clinical Trials (7-minute video)
• Phases of Clinical Trial (7-minute video)
• Clinical Trials – What You Need to Know (2-minute video focusing on biopharmaceuticals) 

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Relevant Publications

• Schultz, A., Saville, B. R., Marsh, J. A., & Snelling, T. L. (2019). An introduction to clinical trial design. Pediatric Respiratory Reviews, 32, 30-35.
• Janiaud, P., Serghiou, S., & Ioannidis, J. P. A. (2019). New clinical trial designs in the era of precision medicine: An overview of definitions, strengths, weaknesses, and current use in oncology. Cancer Treatment Reviews, 73, 20-30.
• Thorat, S. B., Banarjee, S. K., Gaikwad, D. D., Jadhav, S. L., Thorat, R. M. (2010). Clinical trial: A review. International Journal of Pharmaceutical Sciences Review and Research, 1(2): 101-106.

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