A Fatal Flaw in the Clinical Trial Consenting Process

Clinical trials are the lifeblood of treatment progress.  Without clinical trials, we would be unable to make any progress, develop new treatments or increase our understanding of any disease, including cancer.

The good news is that there is a constant stream of trials; the bad news is that many clinical trials never are concluded because they are unable to recruit adequate numbers of participants.  The inability to complete clinical trials directly translates into effective treatments never seeing the light of day!

There are many reasons that trials fail because of lack of patient recruitment.  One of the main reasons comes from many patients’ lack of trust.  The lack of trust is especially true of minority patients, but this problem is not limited to just this population.

Although not the only barrier to clinical trial recruitment the failure of cancer patients to understand what is involved in a clinical trial leads to a lack of trust.  The lack of trust even extends to people who have participated in prior trials.  However, doctors and researchers offering more explicit explanations could solve this problem. 

In a survey of 1090 adult cancer patients, there were some surprises.  The survey found that more than one-half of participants did not understand the basic concept of clinical trial randomization.

Results of the survey showed that a majority of the survey participants did not take any responsibility for their own healthcare decisions.  The survey reported that 63% of patients reported that they thought that "my doctor would make sure that I got the better treatment in a clinical trial," and 55% said that "my doctor would know which treatment in a clinical trial was better."

The concept of randomization was also not understood though about a third (30%) had already taken part in a clinical trial.  More than half of these patients did not realize that randomization means that the treatment would be allocated by chance and did not guarantee that they would receive the investigational treatment, which they had felt that their doctor was recommending.

Also startling was the finding that among the cancer patients, who had not already participated in a clinical trial, the proportion was even higher 73% did not understand that the choice of treatment might be made by chance.

According to the lead author of the study, Dr. Catherine Kelly, "There is also the concept of clinical equipoise (randomization), that the reason you are doing the clinical trial is because there is uncertainty over which is the best option.”  She also said that she found these results even more surprising because even patients who had been in a clinical trial still felt that the treating physician would choose the best treatment and, even more worrying, that the physician would make sure that they were getting the best treatment.

The findings suggest that oncologists and their research teams are not being adequately transparent with their patients.  This lack of transparency, in Cancer ABCs’ opinion, borders on criminality. 

Doctors and research teams need to explain these concepts.  They need to be sure that each patient understands these basic concepts before allowing any of them to begin their participation in any trial. 


European Society for Medical Oncology (ESMO) 2017 Congress. Abstract 1465P_PR, presented September 10, 2017.