randomized controlled trials
Definition:
Randomized controlled trials are studies in which participants are randomly assigned to either the group receiving the intervention being studied or the group receiving the control treatment. Data is then collected to analyze any differences in outcome both positive (benefit) and negative (risk) between groups to assess the intervention’s effects.
Relevance:
The randomization of participants ideally produces an even distribution of participant characteristics, therefore minimizing bias and potential confounding variables in the study. This provides a reliable method for assessing relationships between the intervention being studied and the outcome with the caveat that the results can only be applied to the population being studied. However, randomized controlled trials with small sample sizes may still have issues regarding bias as some potential confounders may be more prevalent in some groups. Thus, the larger the randomized controlled trials, the lower the risk for bias. Additionally, it’s important to note that many randomized trials are under-powered for the detection of infrequent but serious adverse drug effects.
Teaching Tips:
https://www.youtube.com/watch?v=e-RH60crR64
Linked terms: Clinical trials, Phase I clinical trials, Phase II clinical trials, Phase III clinical trials
Resources:
Hariton, E., & Locascio, J. J. (2018). Randomised controlled trials - the gold standard for effectiveness research: Study design: randomised controlled trials. BJOG: an international journal of obstetrics and gynaecology, 125(13), 1716. https://doi.org/10.1111/1471-0528.15199
Kendall, J. M. (2003, March 1). Designing a research project: randomised controlled trials and their principles. Emergency Medicine Journal, 20(2), 164–168. https://doi.org/10.1136/emj.20.2.164
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