Description of the types and content of phase 1 clinical trial consent conversations in practice.

BACKGROUND OR AIMS: All agree that informed consent is a process, but past research has focused content analyses on post-consent or on one conversation in the consent series. Our aim was to identify and describe the content of different types of consent conversations. METHODS: We conducted a secondary analysis of 38 adult oncology phase 1 consent conversations, which were audio-recorded, transcribed, coded, and qualitatively analyzed for type and content. RESULTS: Four types of consent conversations were identified: (1) priming, (2) patient-centered options, (3) trial centered, and (4) decision made. The analysis provided a robust description of the content discussed in each type of conversation. Two themes, supportive care and prognosis, were rarely mentioned. Four themes clustered in the patient-centered (type 2) conversations: affirmation of honesty, comfort, progression, and offer of supportive care. CONCLUSION: We identified and described four types of consent conversations. Our novel findings include (1) four different types of conversations with one (priming) not mentioned before and (2) a change of focus from describing the content of one phase 1 consent conversation to describing the content of different types. These in-depth descriptions provide the foundation for future research to determine whether the four types of conversations occur in sequence, thus describing the structure of the consent process and providing the basis for coaching interventions to alert physicians to the appropriate content for each type of conversation. A switch from a focus on one conversation to the types of conversations in the process may better align the consent conversations with the iterative process of shared decision making.

Therapeutic misconception, misestimation, and optimism in participants enrolled in phase 1 trials.

BACKGROUND: Ethical concerns about phase 1 trials persist. Important conceptual advances have been made in understanding concepts used to describe misunderstanding. However, a systematic, empirical evaluation of the frequency of misunderstanding incorporating recent developments is lacking. METHODS: The authors queried 95 participants in phase 1 trials to provide a more sophisticated estimate of the proportion who had therapeutic misconception (TM), defined as misunderstanding the research purpose or how research differs from individualized care, and therapeutic misestimation (TMis), defined as incorrectly estimating the chance of a research trial benefit as >20% or underestimating risk as 0%. RESULTS: Sixty-five of 95 respondents (68.4%) had TM, which was associated in a multivariate analysis with lower education and family income (P = .008 and P = .001, respectively), but TM was not associated with the vulnerability of having hardly any treatment options. Eighty-nine of 95 respondents (94%) had TMis, although only 18% reported this was a factual estimate. Although the risks of investigational agents and those exacerbated by research, such as uncertain outcomes, were mentioned (39% and 41% of respondents, respectively), risks novel to research, such as research biopsies, were rarely mentioned (3% of respondents). Although most of these respondents believed that their chance of benefit was greater and that their risk was lower than the population chance (optimists) (54.6%), a substantial minority of respondents (37.6%) were pessimists. CONCLUSIONS: TM continues to be prevalent. Estimates of personal benefit were not usually meant to report facts, it remains unknown whether respondents in the current study had TMis. Although they are not more vulnerable, phase 1 participants need improved understanding of key TM concepts, with attention to risks that are not present in standard of care.