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Randomized Controlled Trial

By Julia Simkus, published March 03, 2022


A randomized control trial (RCT) is a type of study design that involves randomly assigning participants into either an experimental group or a control group.

In the control group, the participants do not receive the new treatment or intervention, but instead receive a placebo or reference treatment.

Apart from the treatment or intervention being studied, the two groups should be supervised and observed identically. Because the participants are randomly assigned, the characteristics between the two groups should be balanced, enabling researchers to attribute any differences in outcome to the study intervention.

Without randomization, researchers might consciously or subconsciously assign patients to a particular group for various reasons.

Since researchers can be confident that any differences between the groups are due solely to the effects of the treatments, scientists view RCTs as the gold standard for clinical trials.

Evidence-based medicine pyramid.

Figure 1. Evidence-based medicine pyramid. The levels of evidence are appropriately represented by a pyramid as each level, from bottom to top, reflects the quality of research designs (increasing) and quantity (decreasing) of each study design in the body of published literature. For example, randomized control trials are higher quality and more labor intensive to conduct, so there is a lower quantity published.

Advantages

Prevents bias

In randomized control trials, participants must be randomly assigned to either the intervention group or the control group, such that each individual has an equal chance of being placed in either group.

This is meant to prevent selection bias and allocation bias and achieve control over any confounding variables to provide an accurate comparison of the treatment being studied.

Because the distribution of characteristics of patients that could influence the outcome are randomly assigned between groups, any differences in outcome can be explained only by the treatment.

High statistical power

Because the participants are randomized and the characteristics between the two groups are balanced, researchers can assume that if there are significant differences in the primary outcome between the two groups, the differences are likely to be due to the intervention.

This warrants researchers to be confident that randomized control trials will have high statistical power compared to other types of study designs.

Blinding

Since the focus of conducting a randomized control trial is eliminating bias, blinded RCTs can help minimize any unconscious information bias.

In a blinded RCT, the participants do not know which group they are assigned or which intervention is received. This blinding procedure should also apply to researchers, health care professionals, assessors, and investigators when possible.

“Single blind” refers to an RCT where participants do not know the details of the treatment but the researchers do.

“Double blind” refers to an RCT where both participants and data collectors are masked of the assigned treatment.

Limitations

Costly and Timely

Some interventions require years or even decades to evaluate, rendering them expensive and time consuming.

It might take an extended period of time before researchers are able to identify the effects of a drug or discover significant results.

Requires large sample size

There must be enough participants in each group of a randomized control trial so researchers can detect any true differences or effects in outcomes between the groups.

Researchers are unable to detect clinically important results if the sample size is too small.

Change in population over time

Because randomized control trials are longitudinal in nature, it is almost inevitable that some participants will not complete the study, whether due to death, migration, non-compliance, or loss of interest in the study.

This tendency is known as selective attrition and can threaten the statistical power of an experiment.

Ethics

Randomized control trials are not always practical or ethical, and such limitations can prevent researchers from conducting their studies.

For example, a treatment could be too invasive, or administering a placebo instead of an actual drug during a trial for treating a serious illness could deny a participant’s normal course of treatment. Without ethical approval, a randomized control trial cannot proceed.

Fictitious Example

An example of an RCT would be a clinical trial that compares the effect of a drug or a new treatment on a select population.

The researchers would randomly assign participants to either the experimental group or the control group, and compare the differences in outcomes between those who receive the drug or treatment and those who do not.

Real-life Examples

  • Preventing illicit drug use in adolescents: Long-term follow-up data from a randomized control trial of a school population (Botvin et al., 2000).
  • A prospective randomized control trial comparing medical and surgical treatment for early pregnancy failure (Demetroulis et al., 2001).
  • A randomized control trial to evaluate a paging system for people with traumatic brain injury (Wilson et al., 2009).
  • Prehabilitation versus Rehabilitation: A Randomized Control Trial in Patients Undergoing Colorectal Resection for Cancer (Gillis et al., 2014).
  • A Randomized Control Trial of Right-Heart Catheterization in Critically Ill Patients (Guyatt, 1991).
  • Preventing illicit drug use in adolescents: Long-term follow-up data from a randomized control trial of a school population (Botvin et al., 2000).
  • Berry, R. B., Kryger, M. H., & Massie, C. A. (2011). A novel nasal excitatory positive airway pressure (EPAP) device for the treatment of obstructive sleep apnea: A randomized controlled trial. Sleep, 34, 479–485.
  • Gloy, V. L., Briel, M., Bhatt, D. L., Kashyap, S. R., Schauer, P. R., Mingrone, G., . . . Nordmann, A. J. (2013, October 22). Bariatric surgery versus non-surgical treatment for obesity: A systematic review and meta-analysis of randomized controlled trials. BMJ, 347.
  • Streeton, C., & Whelan, G. (2001). Naltrexone, a relapse prevention maintenance treatment of alcohol dependence: A meta-analysis of randomized controlled trials. Alcohol and Alcoholism, 36(6), 544–552.

About the Author

Julia Simkus is an undergraduate student at Princeton University, majoring in Psychology. She plans to pursue a PhD in Clinical Psychology upon graduation from Princeton in 2023. Julia has co-authored two journal articles, one titled “Substance Use Disorders and Behavioral Addictions During the COVID-19 Pandemic and COVID-19-Related Restrictions," which was published in Frontiers in Psychiatry in April 2021 and the other titled “Food Addiction: Latest Insights on the Clinical Implications," to be published in Handbook of Substance Misuse and Addictions: From Biology to Public Health in early 2022.

How to reference this article:

Simkus, J. (2022, March 03). Randomized Controlled Trial. Simply Psychology. www.simplypsychology.org/randomized-controlled-trial.html

Sources

Akobeng, A.K., Understanding randomized controlled trials. Archives of Disease in Childhood, 2005; 90: 840-844.

Bell, C. C., Gibbons, R., & McKay, M. M. (2008). Building protective factors to offset sexually risky behaviors among black youths: a randomized control trial. Journal of the National Medical Association, 100(8), 936-944.

Bhide, A., Shah, P. S., & Acharya, G. (2018). A simplified guide to randomized controlled trials. Acta obstetricia et gynecologica Scandinavica, 97(4), 380-387.

Botvin, G. J., Griffin, K. W., Diaz, T., Scheier, L. M., Williams, C., & Epstein, J. A. (2000). Preventing illicit drug use in adolescents: Long-term follow-up data from a randomized control trial of a school population. Addictive Behaviors, 25(5), 769-774.

Demetroulis, C., Saridogan, E., Kunde, D., & Naftalin, A. A. (2001). A prospective randomized control trial comparing medical and surgical treatment for early pregnancy failure. Human Reproduction, 16(2), 365-369.

Gillis, C., Li, C., Lee, L., Awasthi, R., Augustin, B., Gamsa, A., ... & Carli, F. (2014). Prehabilitation versus rehabilitation: a randomized control trial in patients undergoing colorectal resection for cancer. Anesthesiology, 121(5), 937-947.

Globas, C., Becker, C., Cerny, J., Lam, J. M., Lindemann, U., Forrester, L. W., ... & Luft, A. R. (2012). Chronic stroke survivors benefit from high-intensity aerobic treadmill exercise: a randomized control trial. Neurorehabilitation and Neural Repair, 26(1), 85-95.

Guyatt, G. (1991). A randomized control trial of right-heart catheterization in critically ill patients. Journal of Intensive Care Medicine, 6(2), 91-95.

MediLexicon International. (n.d.). Randomized controlled trials: Overview, benefits, and limitations. Medical News Today. Retrieved from https://www.medicalnewstoday.com/articles/280574#what-is-a-randomized-controlled-trial

Wilson, B. A., Emslie, H., Quirk, K., Evans, J., & Watson, P. (2005). A randomized control trial to evaluate a paging system for people with traumatic brain injury. Brain Injury, 19(11), 891-894.

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