There are multiple reasons why patients decide not to participate in clinical trials, and it is essential that healthcare providers understand them to overcome barriers.
Adult participation in cancer clinical trials lags far behind that within the pediatric population,1 limiting the availability of research results to guide therapy decision-making. Interventions are needed to foster improved participation. Yet first and foremost, we need to know why adult participation rates are so low. Numerous reasons have been cited.
Having worked as a research nurse, I have heard an abundance of reasons for low attrition from both providers and patients. Physicians in busy office practices have time constraints limiting their availability to explain the nature of trials. A lack of research personnel in the ambulatory setting is also a barrier. Dedicated staff are needed to determine trial eligibility, engage in the consent process, manage required paperwork, oversee laboratory and radiologic testing, and at times work with pharmacy to ensure the safety and stocking of study drugs.
From patients, the most common response I’ve heard is something along the lines of, “I don’t want to be a guinea pig.” Additionally, there may be added clinic visits, confusion about the randomization process, and misunderstanding about withdrawal or stopping the trial. Lastly, the consent process is overwhelming for many potential trial participants. To ensure that the complete nature of the trial is described and patient safety is ensured, explicit details of the trial are spelled out at length in the consent document. While the use of medical jargon is minimized in the consent, the specifics of the trial often remain confusing.
The outcomes of a Delphi consensus investigation were published. The aim was to establish essential information needed to enhance the informed consent process in an adult sample.2 Ultimately, 15 consensus statements were identified as being key to patient understanding about trial participation that could augment the informed consent process. These included:
The results of this research offer substantive evidence of key information required by adult patients that augments understanding of the informed consent document. The lengthy, detailed, and often-overwhelming informed consent document required by institutional review boards could be accompanied by a supplemental factsheet that specifically addresses common patient concerns. Future testing of this intervention would identify its influence on adult clinical trial accrual rates.
1. Unger JM, Cook E, Tai E, Bleyer A. Role of clinical trial participation in cancer research: Barriers, evidence and strategies. Am Soc Clin Oncol Educ Book. 35: 185-198.
2. Kao CY, Aranda S, Krishnasamy M, Hamilton B. Identifying essential information to support patient decision-making regarding participation in cancer clinical trials: A Delphi study. Eur J Cancer Care, 27: e12954.