Adverse Events Occurring for Placebo Groups in Cancer Trials

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Diego Enrico, MD of the Argentine Association of Clinical Oncology, Buenos Aires, Argentina and colleagues examined the incidence of placebo Adverse Events reported in randomized clinical trials of modern cancer drugs in the adjuvant setting.  Thereafter, they utilized MEDLINE to conduct a systematic literature review of English-language publications from January 1, 2000 to April 15, 2018. The review included only Phase 3 double-blind, randomized, placebo-controlled studies that enrolled patients who had undergone macroscopically complete resections according to John Schieszer with Oncology Nursing Advisor.  Dr. Enrico noted “our study was started after noticing that many clinical trials reported elevated rates of higher-grade adverse events in patients who were not receiving anticancer treatment and were assumed to be free of disease. After reviewing existing evidence, we observed that the nocebo effect is not well described in cancer patients.”

The study takeaway is that those patients enrolling in clinical trials involving targeted and immunotherapy cancer agents should be better educated that AEs may occur even in the case that an inert substance may be involved. This meta-analysis was published in JAMA Network Open.

Lead Research/Investigator

Diego Enrico, MD