Proposing phase I studies: Patients', relatives', nurses' and specialists' perceptions

Tomamichel, Michele; Jaime, Herlinda Bonilla; Degrate, Alessandro; Jong, J. de; Pagani, Olivia; Cavalli, F.; Sessa, Cristiana

doi:10.1023/a:1008393031299

Cited by 32 publications

(21 citation statements)

References 18 publications

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“…Research demonstrates that investigators expect greater benefits and higher toxicity than studies show [6,19,20], and observation is needed to ensure investigators are not communicating unsupported beliefs and expectations to patients. Trust in the investigator is an important factor in the decision-making process [9,22,24,25]; hence, investigators have a responsibility to be aware of their own agendas and communicate unbiased information.…”

Section: Resultsmentioning

confidence: 99%

Communication and informed consent in phase 1 trials: a review of the literature

Cox

Fallowfield

Jenkins

2006

Support Care Cancer

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Phase 1 (P1) trials are vital to the development of cancer treatments; however, the patients involved in these trials are unlikely to receive any therapeutic benefit, and there are significant possibilities that they will experience serious side effects. Ethical requirements stipulate that patients must be adequately informed before they consent to participate in P1 trials. This review focuses on studies that have measured patient comprehension of information given during the informed consent process of P1 cancer trials. Patients consenting to participate in P1 trials currently have a limited understanding of trial purpose, an unrealistic expectation of the benefits and risks associated with trial participation and a questionable appreciation of their right to abstain or withdraw. Health care professionals recruiting to P1 trials need clear and practical guidelines and training packages designed to ensure that all details of P1 trials are communicated effectively to eligible patients.

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Section: Resultsmentioning

confidence: 99%

Communication and informed consent in phase 1 trials: a review of the literature

Cox

Fallowfield

Jenkins

2006

Support Care Cancer

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“…Unfamiliar terms such as randomization and placebo are particularly hard to understand [6]–[9], as are concepts related to risks [10], [11], benefits [12]–[14], and the freedom to withdraw from the study [15]–[18]. Additionally it has been shown that many trial participants are unaware that they are enrolled in research [18]–[20].…”

Section: Introductionmentioning

confidence: 99%

Repeated Assessments of Informed Consent Comprehension among HIV-Infected Participants of a Three-Year Clinical Trial in Botswana

et al. 2011

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BackgroundInformed consent (IC) has been an international standard for decades for the ethical conduct of clinical trials. Yet frequently study participants have incomplete understanding of key issues, a problem exacerbated by language barriers or lack of familiarity with research concepts. Few investigators measure participant comprehension of IC, while even fewer conduct interim assessments once a trial is underway.Methods and FindingsWe assessed comprehension of IC using a 20-question true/false quiz administered in 6-month intervals in the context of a placebo-controlled, randomized trial for the prevention of tuberculosis among HIV-infected adults in Botswana (2004–2009). Quizzes were offered in both Setswana and English. To enroll in the TB trial, participants were required to have ≥16/20 correct responses. We examined concepts understood and the degree to which understanding changed over three-years. We analyzed 5,555 quizzes from 1,835 participants. The participants' highest education levels were: 28% primary, 59% secondary, 9% tertiary and 7% no formal education. Eighty percent of participants passed the enrollment quiz (Quiz1) on their first attempt and the remainder passed on their second attempt. Those having higher than primary education and those who took the quiz in English were more likely to receive a passing score on their first attempt (adjusted odds ratios and 95% confidence intervals, 3.1 (2.4–4.0) and 1.5 (1.2, 1.9), respectively). The trial's purpose or procedures were understood by 90–100% of participants, while 44–77% understood randomization, placebos, or risks. Participants who failed Quiz1 on their initial attempt were more likely to fail quizzes later in the trial. Pass rates improved with quiz re-administration in subsequent years.ConclusionsAdministration of a comprehension quiz at enrollment and during follow-up was feasible in a large, international collaboration and efficiently determined IC comprehension by trial participants. Strategies to improve understanding of concepts like placebos and randomization are needed. Comprehension assessments throughout a study may reinforce key concepts.

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“…palliative care) but do not seriously consider them. When asked why they choose to participate, they say that this is the only way for them to maintain their hope of fighting their cancer, and that almost no adverse effect, including death, would dissuade them from enrolling [17]. Again, rather than having therapeutic misconceptions, the interviewed patients demonstrate that they are guided by therapeutic optimism [18,19], with only 3% reporting personally to be very or somewhat unlikely to benefit from participating in phase I studies.…”

Section: Role Of Optimism Bias With Regard To Participating In Phase mentioning

confidence: 99%

Decision-Making Process Related to Participation in Phase I Clinical Trials: A Nonsystematic Review of the Existing Evidence

Gorini

Mazzocco

Pravettoni

2015

Public Health Genomics

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Due to the lack of other treatment options, patient candidates for participation in phase I clinical trials are considered the most vulnerable, and many ethical concerns have emerged regarding the informed consent process used in the experimental design of such trials. Starting with these considerations, this nonsystematic review is aimed at analyzing the decision-making processes underlying patients' decision about whether to participate (or not) in phase I trials in order to clarify the cognitive and emotional aspects most strongly implicated in this decision. Considering that there is no uniform decision calculus and that many different variables other than the patient-physician relationship (including demographic, clinical, and personal characteristics) may influence patients' preferences for and processing of information, we conclude that patients' informed decision-making can be facilitated by creating a rigorously developed, calibrated, and validated computer tool modeled on each single patient's knowledge, values, and emotional and cognitive decisional skills. Such a tool will also help oncologists to provide tailored medical information that is useful to improve the shared decision-making process, thereby possibly increasing patient participation in clinical trials.

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Proposing phase I studies: Patients', relatives', nurses' and specialists' perceptions

Cited by 32 publications

References 18 publications

Communication and informed consent in phase 1 trials: a review of the literature

Communication and informed consent in phase 1 trials: a review of the literature

Repeated Assessments of Informed Consent Comprehension among HIV-Infected Participants of a Three-Year Clinical Trial in Botswana

Decision-Making Process Related to Participation in Phase I Clinical Trials: A Nonsystematic Review of the Existing Evidence

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