Optimism and oncology trials: help or hindrance?

Abstract

A fundamental tenant in the ethical conduct of human subject research is that participants enrolling in a clinical trial be properly informed and consented [1]. Any contribution towards the improvement of the consent process in clinical research is to be lauded, and the work presented by Jansen et al. in the January–February 2011 issue of IRB is an important contribution to the field [2]. Their research focused on determining how well cancer patients, considering enrollment into early-phase oncology trials, assess their probability of benefitting or being harmed by participating in a clinical trial. In their article, Jansen et al. published the results of a small, prospective, observational study involving 72 patients being enrolled in various early-phase (Phase I, I/II and II) oncology studies. The study confirmed the authors underlying hypothesis: that ‘unrealistic optimism’ is present in a population of patients enrolled in earlyphase oncology trials, and that this phenomena was unrelated to the existence (or not) of therapeutic misconception [2]. However, an important and as yet unanswered question remains from Jansen et al.’s work: at what point does the presence of cognitive bias (in the form of unrealistic optimism) undermine the decision-making capacity of a potential trial participant, such that it becomes ethically problematic to enroll that participant into a study? In most countries, the legal requirements underpinning the doctrine of informed consent requires that investigators who are responsible for enrolling research subjects into their study must ensure that participants are capable of making an informed decision. The accepted standard in the determination of decisional capacity requires that the participant is able to understand the information relevant to making a decision and appreciate the reasonably foreseeable consequences of a decision to enter or not enter into the trial [3]. The requisite ability to understand and appreciate is determined during the informed consent process, when the protocol is discussed with the prospective research subject. In addition, the investigator must also ensure that the consent is voluntary and not initiated through misrepresentation. Informed consent for incapable research subjects is still possible through a proxy or substitute decision maker when allowed for in the research protocol. Full disclosure is essential to a valid informed consent process – but it is not sufficient. Emphasis must also be placed on ensuring the information is understood and assimilated by the research subject. The criteria for establishing the degree of understanding and appreciating would seem to be at the heart of the issue we are most concerned with. Understanding information is a very different process compared with transmitting or conveying information. Ethicists and trialists have spent considerable effort studying the methods intrinsic to the transmission of information to potential participants. Practices that reduce the likelihood of being coercive for research subjects are encouraged, such as, suggesting physician/investigators employ