The use of a placebo arm in clinical trials is unethical if there is an active comparator that is acceptably safe and effective. We argue that reasonable evidence of effectiveness and safety of an inexpensive alternative to an expensive therapy is sufficient to require that the inexpensive therapy be included as a comparator when the expensive therapy is tested, and that use of an inactive placebo comparator only is not ethical. For example, studies of the expensive drug eplerenone for congestive heart failure have not included a spironolactone arm, although there is reasonable evidence that spironolactone would be safe and effective, and spironolactone is inexpensive. The requirement to study inexpensive therapies is based on avoidance of unnecessary cost in medical care as an example of non-maleficence. Several ethical actors in the design, conduct, and publication of clinical trials and their results bear responsibility for the appropriate conduct of clinical trials. That responsibility includes protecting study subjects from being asked to participate in clinical trials that serve primarily to promote the use of new and expensive therapies.
- Drugs and Drug Industry
- General Medicine / Internal Medicine
- Policy Guidelines/Inst. Review Boards/Review Cttes.
Statistics from Altmetric.com
If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.
Read the full text or download the PDF:
Other content recommended for you
- Cost-effectiveness of eplerenone in patients with systolic heart failure and mild symptoms
- The renin-angiotensin-aldosterone system in heart failure for the non-specialist: the past, the present and the future
- Effects of spironolactone on endothelial function, vascular angiotensin converting enzyme activity, and other prognostic markers in patients with mild heart failure already taking optimal treatment
- Aldosterone antagonists improve ejection fraction and functional capacity independently of functional class: a meta-analysis of randomised controlled trials
- Long-term effect of cardiac resynchronisation in patients reporting mild symptoms of heart failure: a report from the CARE-HF study
- An evidence-based review of recent advances in therapy for heart failure with reduced ejection fraction (HFrEF)
- Cost-effectiveness of implantable cardiac devices in patients with systolic heart failure
- Development of an economic model to assess the cost-effectiveness of hawthorn extract as an adjunct treatment for heart failure in Australia
- Is there benefit in implanting defibrillators in patients with severe heart failure?
- Added value of a physician-and-nurse-directed heart failure clinic: results from the Deventer–Alkmaar heart failure study