Could clarifying clinical trial concepts increase patient participation?

Novel research indicates that the majority of patients do not understand the core concepts underpinning a clinical trial and that increasing patient understanding may help to boost patient enrollment to trials.

The study ran from the 22 April 2016 to 23 November 2016 and gathered data from 14 participating oncology centers. The centers administered anonymized questionnaires to 1090 adult patients with a diagnosed malignancy. The patients were asked to evaluate statements concerning clinical trials and research, and indicate a true or false answer. 98.3% of patients considered it important to have clinical trials, while 82.3% reported an understanding of the term medical/cancer clinical trials. The results were presented at the ESMO 2017 Congress (8–12 September, Madrid, Spain).

Consistent with previous studies, the characteristics of randomization and chance proved to be problematic elements. Over half of previous clinical trial patients and the majority of those who had never been enrolled in one, did not understand that the treatments administered would be randomized. Only 33.5% of patients responded ‘True’ to the statement, ‘In a randomized trial the treatment you get is decided by chance’.

There is some debate as to whether the patients understand clinical equipoise. The statement, ‘My doctor would know which treatment in a clinical trial was better’ received a 56.5% answer rate of ‘True’. Study author Catherine Kelly (Mater Misericordiae University Hospital, Ireland) observed: “We also found that most patients did not understand clinical equipoise: the fact that no one knows which treatment is best. Surprisingly, this was more marked in previous clinical trial participants, 60%of whom believed that their doctor would know which study arm was best.”

Bettina Ryll of ESMO Patient Advocates Working Group questioned whether the perceived misunderstanding might be more readily explained by differences in practical concern: “When we talk about understanding, it is important to consider that patients and physicians approach clinical trials from different perspectives […] finding out whether a treatment is 51% better or only 49% may matter to a Health Technology Assessment assessor, but not to a patient. This undermines the conclusion that patients simply do not understand equipoise.” She also pointed to the median age of respondents, 60 years, suggesting that younger patient groups, who access information in a very different way, could provide an interesting comparison point.

Understanding the key concepts of clinical trials is essential to a patient’s ability to provide informed consent when participating in one or to alleviate apprehensions that might otherwise prevent a patient from participation in the first place. The statement ‘Clinical trials are only used when standard treatments have not worked’ received a 22% answer rate of ‘True’. “To improve participation in clinical trials, we need to understand the factors influencing patients’ decisions about taking part,” Kelly explained, “As we analyze the data further, we will be able to offer physicians a more detailed picture of the questions patients need answered and the factors that influence their decision-making.”

Sources: ESMO press release: The European Society for Medical Oncology 2017 Congress. Madrid, Spain, 8–12 September (2017) (Abstract 1465P_PR).