The Ethics of Placebos in Clinical Trials

This is a follow up from Anjannette Sorensen from our Research Department that will clarify many of the concerns that were shared in the last post about the use of placebos in clinical trials.  Thank you Anjannette!

Ethics, Placebos, and Cancer Treatment Centers of America at Midwestern

             Nearly every drug, treatment, or device used in medical treatment was once part of a clinical trial. Some research involves using placebos to measure the validity of what is being tested. All research is governed by a Code of Ethics, but there has been a controversy involving placebos ever since placebo-controlled trials have been used. There are those that believe that “placebo orthodoxy sacrifices ethics and the rights and welfare of patients to presumed scientific rigor”, and there are those that believe it is necessary methodologically for validity (1). Most researchers agree that use of a placebo in subjects with life-threatening conditions when effective treatment is available is unethical (2).

            Dr. Ahn, Medical Director of Clinical Research, and Bruce Steinert PhD, Director of Clinical Research at MRMC, look for phase II and phase III studies that will benefit our patients. At CTCA, studies with a placebo-only arm are not allowed unless the standard of care (SOC) is watchful waiting. The studies that land here have already had animal studies and phase I trials done and the treatment shows some promise before they become a phase II trial. Phase II trials are typically looking at efficacy, so there is a chance of no direct benefit to the patient. This is also true of the SOC – some patient’s cancers respond better than others. If clinical research has a study that uses placebos; it is usually paired with the SOC.  For example; CTCA currently has an open study for NSCLC that is SOC Taxol/Carboplatin + Veliparib vs. Placebo. In this blinded study, the patient is assured of getting the usual first line treatment for their particular cancer. The patient’s recognize that they have a chance of getting a new drug/treatment not yet approved by the FDA and that they are contributing to the advancement of cancer care.

            Additionally, when patients enter a research study, they are never more meticulously monitored. Every side effect, adverse event, medication, past medical/surgical history is tracked and their current status is monitored closely by a team of research specialists. Patients will also have scans more frequently to check for progression. As soon as progression is discovered, the patient will be taken off the study. Physicians still make the final decisions and if they feel that the patient’s health is in question they will take the patient off-study and offer alternative treatments.

            CTCA’s Clinical Research department is really part of the clinical care team. “We are a treatment option”, as India Hill, Director of Clinical Trial Operations, states. Research needs to be thought of as a hopeful option; a chance to have a shot at the latest drugs and treatments that are not yet FDA approved. It is also a chance for the patients to feel that they contributed to the greater good for the future of cancer care.

Anjanette Sorensen BSN RN

Clinical Research Coordinator

CTCA @ Midwestern

References

1.     Emmanuel E & Miller F. The Ethics of Placebo-Controlled Trials – A Middle Ground. N Engl J Med. 2001; 345: 915-919.

2.     Simon R DSc. Are Placebo-Controlled Clinical Trials Ethical or Needed When Alternative Treatment Exists? Ann Intern Med. 2000; 133: 474-475.