Question 1 · Biostatistics and epidemiology, Preclinical
A new drug is to be tested for a condition for which a standard treatment is already available. Which comparison group should the trial use?
- A. Physiotherapy
- B. A newer experimental drug
- C. An identical placebo with no active ingredient
- D. The current standard treatment
- E. Surgery
Show the answer and explanation
Answer: D. The current standard treatment
A placebo is often used for comparison, but if a standard treatment is available this should be used as the control, so the trial compares the intervention with the standard of care. A control group is the comparison group receiving standard treatment or placebo.
Why the other options are wrong
- A. Physiotherapy: Physiotherapy is the control group when surgery is the experimental intervention.
- B. A newer experimental drug: A new drug is the experimental intervention, with the old drug as the control group.
- C. An identical placebo with no active ingredient: If a standard treatment is available it should be used as the control, and it is not ethical to use placebo in many circumstances.
- E. Surgery: Surgery is the experimental intervention when physiotherapy is the control group.
Key point: When a standard treatment is available, it should be used as the control group.
References
- CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials, BMJ 2010 (PMC full text)
- Randomised trial of cholesterol lowering in 4444 patients with coronary heart disease: the Scandinavian Simvastatin Survival Study (4S), Lancet 1994;344:1383-89 (Europe PMC abstract record)
- Allocation bias, Catalogue of Bias Collaboration