Therapeutic Misperceptions in Early‐Phase Cancer Trials: From Categorical to Continuous

Sisk, Bryan A.; Kodish, Eric

doi:10.1002/eahr.404003

Cited by 13 publications

(12 citation statements)

References 46 publications

(19 reference statements)

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“…Rather, they are often desperate and are hoping for the remote possibility of receiving medical benefit (Christofides et al, 2017), or for any number of positive psychological functions that hope serves (Sulmasy et al, 2010). In light of these developments, scholars now make a distinction between true TM, which is apparently more rare, and “therapeutic optimism,” where “prospective participants and actual research subjects understand the likelihood of benefit but hope they will personally benefit from participation” (Sisk & Kodish, 2018, p. 14).…”

Section: Empirical Studies Of Self-interest and Altruism In Trial Enrmentioning

confidence: 99%

Self-Interested and Altruistic Motivations in Volunteering for Clinical Trials: A More Complex Relationship

Olsen

DePalma

Evans

2020

Journal of Empirical Research on Human Research Ethics

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Empirical studies have found that altruism and self-interest are the two primary motivations for enrollment in clinical trials. Some studies have shown that in some cases these two motivations are contingent upon each other, which complicates our understanding of motivation. In this study, we interviewed 27 people with Parkinson’s disease about their willingness to enroll in a hypothetical clinical trial. Through inductive, grounded theory analysis of the interview transcripts, we find four different contingent relationships between altruism and self-interest. It is important for ethicists to be aware of these more complex motivations because some are ethically problematic and others not. Moreover, practitioners need to be aware of these contingent relationships so that they can understand the motivations of the research participants.

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Section: Empirical Studies Of Self-interest and Altruism In Trial Enrmentioning

confidence: 99%

Self-Interested and Altruistic Motivations in Volunteering for Clinical Trials: A More Complex Relationship

Olsen

DePalma

Evans

2020

Journal of Empirical Research on Human Research Ethics

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“…Common to both of these forms of misperception is likely to be an underlying hope of therapeutic benefit from research participation. 18,29,30 With regard to consent, these misperceptions become morally significant to the extent that they influence the individual's motivation to enter a trial and, thereby, his or her decision either to grant or to withhold consent. 31,32 I will argue, however, that the way in which we conceptualize such misperception should differ somewhat in relation to PFSs.…”

Section: Therapeutic Misperceptionmentioning

confidence: 99%

“…As lack of information constrains autonomous decision‐making, disclosure on the part of the researcher and comprehension on the part of the participant are prerequisites for consent 16 . Many of the problematic aspects of consent centre, however, on these aspects, 17 and an important issue here is what Sisk and Kodish 18 call therapeutic misperception.…”

Section: Consent In Clinical Studiesmentioning

confidence: 99%

Distinctive aspects of consent in pilot and feasibility studies

Sim

2021

Evaluation Clinical Practice

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Prior to a main randomized clinical trial, investigators often carry out a pilot or feasibility study in order to test certain trial processes or estimate key statistical parameters, so as to optimize the design of the main trial and/or determine whether it can feasibly be run.Pilot studies reflect the design of the intended main trial, whereas feasibility studies may not do so, and may not involve allocation to different treatments. Testing relative clinical effectiveness is not considered an appropriate aim of pilot or feasibility studies.However, consent is no less important than in a main trial as a means of morally legitimizing the investigator's actions. Two misperceptions are central to consent in clinical studies-therapeutic misconception (a tendency to conflate research and therapy) and therapeutic misestimation (a tendency to overestimate possible benefits and/or underestimate possible harms associated with participation). These phenomena may take a distinctive form in pilot and feasibility studies, owing to potential participants' likely prior unfamiliarity with the nature and purposes of such studies. Thus, participants may confuse the aims of a pilot or feasibility study (developing or optimizing trial design and processes) with those of a main trial (testing treatment effectiveness) and base consent on this misconstrual. Similarly, a misunderstanding of the ability of pilot and feasibility studies to provide information that will inform clinical care, or the underdeveloped nature of interventions included in such studies, may lead to inaccurate assessments of the objective possibility of benefit, and weaken the epistemic basis of consent accordingly. Equipoise may also be particularly challenging to grasp in the context of a pilot study. The consent process in pilot and feasibility studies requires a particular focus, and careful communication, if it is to carry the appropriate moral weight. There are corresponding implications for the process of ethical approval.

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“…If the person who obtains informed consent has a clinical care relationship with the potential participant, the issue of "therapeutic misconception" arises (Sisk and Kodish 2018). Thus, when the clinician introduces a research study, the patient may interpret that introduction as a recommendation from the clinician, and may improperly attribute the possibility of direct personal benefit to study participation.…”

Section: Who May Obtain Informed Consent?mentioning

confidence: 99%

Consent Forms and Procedures

Ervin¹,

Pettit²

2020

Principles and Practice of Clinical Trials

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Obtaining the informed consent of a participant is a prerequisite for enrollment in a clinical trial. In the United States, federal regulations provide the framework for establishing informed consent with additional protections for persons considered vulnerable due to incarceration, illiteracy, or other condition. Investigators are tasked with providing sufficient information about the research to satisfy the ethical and regulatory requirements while communicating it in a manner that maximizes the participant's ability to make an informed decision regarding study enrollment. There are clinical trial design features that are essential to include in the consent form with care to describe topics such as randomization, allocation ratio, and masking in a manner understood by the lay public. The informed consent discussion should continue throughout the course of the trial as informally reaffirming the participant's willingness to continue participation and reconsenting them when there are significant changes to the study protocol are important considerations for providing truly informed consent.

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Therapeutic Misperceptions in Early‐Phase Cancer Trials: From Categorical to Continuous

Cited by 13 publications

References 46 publications

Self-Interested and Altruistic Motivations in Volunteering for Clinical Trials: A More Complex Relationship

Self-Interested and Altruistic Motivations in Volunteering for Clinical Trials: A More Complex Relationship

Distinctive aspects of consent in pilot and feasibility studies

Consent Forms and Procedures

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