Beyond Genetic Tests and Biomarkers: What About Therapeutic Misconception?

Abstract

Clinical trials are a vital part of the drug development process because they test the safety and efficacy of potential treatments. The primary goal of clinical trials is to obtain valid scientific data to answer research questions that lead to interventions to alleviate suffering. Consequently, protocols are created not to directly benefit the individual clinical trial participant but rather to ensure that the tested intervention meets safety and efficacy endpoints established by the drug sponsor and the regulatory agency (the U.S. Food and Drug Administration or European Medicines Agency, for example). However, participants sometimes confuse the goals of clinical trials with medical care as they underestimate risks and overestimate benefits (Melo-Martin and Ho, 2008). This confusion is known as therapeutic misconception. As a partial remedy for this issue, deficiencies in the informed consent process need to be addressed. Therapeutic misconception can lead to unrealistic expectations and misplaced trust. For example, in phase I clinical trials, researchers want to determine the limits of drug dosage and the drug’s toxicity in humans (Cannon, 2006). Thus, low levels of the drug are given to participants in the early stages of the trials. As the study progresses, the amount of drug administered is gradually increased. It is unrealistic that a participant would expect to benefit from such a study because the dose that causes less toxicity has a smaller chance of being effective (Sankar, 2004). Additionally, the higher dosage can result in adverse events. Thus, although this phase is more about the potential toxicity of the drug, individuals still look for clinical benefits. Underlying these unrealistic expectations is the trust participants put in the researcher. Because of therapeutic misconception, many participants assume that the researcher seeks to improve the participants’ health. Consequently, many participants trust that the researcher will do what is best for them medically, regardless of the protocols’ stipulations. Because trust is integral to health care, this misplaced trust may result in the participant’s having difficulty confidently placing trust in other relationships with health professionals (Melo-Martin and Ho, 2008). Informed consent is ‘‘seen as the last defense against the risks of research, including those associated with the motives and practices of research’’ (Dixon-Woods et al., 2007). Researchers try to address these misconceptions during the informed consent process by discussing the research plan, risks, and benefits of a study. Attempts have been made to improve the consent process in order to eliminate therapeutic misconception. One study added a video to its consent process and tested the knowledge of the participant. Although the video did promote more discussion, it did not succeed in increasing a participant’s knowledge of clinical trials (Hoffner et al., 2012). Another study looked at participants’ perceived understanding, knowledge score, and factors that affect the consent process. The study found that discussions with physicians about the trial that take place before participants signed the consent document and last longer than 30 minutes did increase perceived understanding but did not increase the participant’s knowledge (Bergnemar et al., 2011). These studies demonstrate that examining the informed consent document and presenting information in different ways hasn’t reduced therapeutic misconception. Currently, the paradigm for informed consent is the transmission model: Communication is considered successful if the message is sent to a participant and is received. Social factors that affect whether the message is received, such as expectations or personal relations, are accounted for in the model as ‘‘noise’’ (Sankar, 2004). These social factors, often influenced by psychological, socioeconomic, and cultural factors, are important to consider in evaluating the consent process and should not be dismissed. Therefore, it has been argued that individuals do not make decisions based solely on reason; emotion also plays a role in the process (Charuvastra and Marder, 2006). Moreover, information read is not the only factor in decision-making. Other influences include trust, familiarity, and attraction (Charuvastra and Marder, 2006). Because emotions play a key role in an individual’s decision to join a clinical trial, the consent process needs to be modified to account for the interaction between emotion and reason. Perhaps explicitly defining the researcher–participant relationship in the informed consent process would discourage therapeutic misconception. Establishing a culture of participation in biomedical research might also alleviate this problem by both ‘‘normalizing’’ research participation and accelerating access to treatments for more diseases.