Viewpoint: Patients overestimate the benefits of clinical trials, and physicians may be complicit

Studies show some physicians mislead some patients to believe phase 1 clinical trials will be effective in treating their cancer, Mikkael Sekeres, MD, chief of hematology at Miami-based Sylvester Comprehensive Cancer Center, wrote in an article posted on The Washington Post.

One study surveyed nearly 300 cancer trial patients to determine their primary motivation for participating. Of respondents enrolled in a phase 1 trial, 45 percent said they were motivated by the possibility of receiving medical benefits from the treatment. The other three main motivations were:

  • Trusting the study doctor — 17 percent
  • To maintain hope — 15 percent
  • To help future patients — 4 percent

Phase 1 clinical trials are the first in-human trials. The primary purpose of phase 1 trials is to find the right dose of a drug and assess the safety of that drug, not to determine whether it works. In these trials, the chance that a drug will effectively treat a patient's cancer is historically less than 15 percent, according to the article.

Dr. Sekeres said the patient misconception may be due to physicians miscommunicating the purpose of the research and benefits expected.

One study examined how physicians communicate the risks and benefits of phase 1 trials to 85 families of pediatric cancer patients. Only 95 percent of families were told the risks of the drug treatments. 

"It is a bit surprising that this didn't occur 100 percent of the time, as these phase 1 trials involved chemotherapy," Dr. Sekeres wrote in the article.

Therapeutic benefits were discussed only 88 percent of the time. Medical altruism was mentioned in 41 percent of conversations with families, and 13 percent of conversations described the clinical trial as a bridge to another therapy or to extend life despite no evidence of the drug's effectiveness.

"As health care providers, it's our responsibility to understand those motivations and ensure that our patients don't enroll in a clinical trial with the wrong goal in mind — and take particular care that we don't misinform our patients about what treatment goals are even possible," Dr. Sekeres wrote.

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