Patient information in phase 1 trials: A systematic review

Gad, Katrine Toubro; Lassen, Ulrik; Mau-Soerensen, Morten; Høybye, Mette Terp; Johansen, Christoffer

doi:10.1002/pon.4559

Cited by 6 publications

(5 citation statements)

References 69 publications

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“…Furthermore, if participating in an early phase clinical trial fits patients' values, they may be better motivated to comply to the specific obligations of a trial. Although previous systematic reviews have examined patients' perception, comprehension and understanding of early phase clinical trials [6,7] and general barriers to participate in clinical trials [8], a systematic overview of relevant patient values in this context doesto the best of our knowledgenot yet exist. Such an overview could help healthcare professionals to anticipate patient values in the consultation and thereby support patients in expressing values in light of their decision-making process.…”

Section: Introductionmentioning

confidence: 99%

Identifying patient values impacting the decision whether to participate in early phase clinical cancer trials: A systematic review

Lent

Jabbarian

Gurp

et al. 2021

Cancer Treatment Reviews

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Background: For many patients with advanced cancer, the decision whether to participate in early phase clinical trials or not is complex. The decision-making process requires an in-depth discussion of patient values. We therefore aimed to synthesize and describe patient values that may affect early phase clinical trial participation. Methods: We conducted a systematic search in seven electronic databases on patient values in relation to patients' decisions to participate in early phase clinical cancer trials. Results: From 3072 retrieved articles, eleven quantitative and five qualitative studies fulfilled our inclusion criteria. We extracted ten patient values that can contribute to patients' decisions. Overall, patients who seek trial participation usually report hope, trust, quantity of life, altruism, perseverance, faith and/or risk tolerance as important values. Quality of life and humanity are main values of patients who refuse trial participation. Autonomy and social adherence can be reported by both trial seekers or refusers, dependent upon how they are manifested in a patient. Conclusions:We identified patient values that frequently play a role in the decision-making process. In the setting of discussing early phase clinical trial participation with patients, healthcare professionals need to be aware of these values. This analysis supports the importance of individual exploration of values. Patients that become aware of their values, e.g. by means of interventions focused on clarifying their values, could feel more empowered to choose. Subsequently, healthcare professionals could improve their support in a patients' decision-making process and reduce the chance of decisional conflict.

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Section: Introductionmentioning

confidence: 99%

Identifying patient values impacting the decision whether to participate in early phase clinical cancer trials: A systematic review

Lent

Jabbarian

Gurp

et al. 2021

Cancer Treatment Reviews

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“…8,[26][27][28] Such studies reported high rates of enrollment among those who viewed a consent form, 29 but this may provide limited insight into other factors that shape enrollment. 30 we show here, by the time patients initiated the EP trial process, most had nearly solved the Rubik's cube of enrollment.…”

Section: Discussionmentioning

confidence: 91%

“…Outcome researchers have used pipeline models to examine enrollment, 6,30,31 barriers to enrollment, 32-34 and oncologists' role in enrollment. 17 These models have focused on factors that may cause patients to "leak out" of the trials pipeline (eg, disease progression or eligibility criteria).…”

Section: Discussionmentioning

confidence: 99%

Before Consent: Qualitative Analysis of Deliberations of Patients With Advanced Cancer About Early-Phase Clinical Trials

Garrett

Matthews

Abramson

et al. 2020

JCO Oncology Practice

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PURPOSE: Patients with advanced cancer and oncologists deliberate about early-phase (EP) trials as they consider whether to pursue EP trial enrollment. We have limited information about those deliberations and how they may facilitate or impede trial initiation. This study describes these deliberations and their relationship to trial initiation. PATIENTS AND METHODS: We collected longitudinal, ethnographic data on deliberations of patients with advanced cancer at two academic medical centers. We used constant comparative and framework analyses to characterize the deliberative process and its relationship to trial initiation. RESULTS: Of 96 patients with advanced cancer, 26% initiated EP enrollment and 19% joined a trial. Constant comparative analysis revealed two foci of deliberation. Setting the stage focused on patient and physician support for EP trial involvement, including patients’ interest in research and oncologists’ awareness of trials and assessment of patient fit. Securing a seat focused on eligibility for and entrance to a specific trial and involved trial availability, treatment history, disease progression, and enrollment timing. Patients enrolled in a trial only when both stages could be successfully navigated. CONCLUSION: Ethnographic data revealed two foci of deliberation about EP trial enrollment among patients with advanced cancer. Physician support played a consequential role in both stages, but enrollment also reflected factors beyond the control of any specific individual. Insights from this study, combined with other recent studies of trial enrollment, advance our understanding of the complex process of EP trial accrual and may help identify strategies to improve rates of participation.

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“…Other studies of participation in phase 1 oncology trials have considered the minimal chances of a therapeutic benefit as being, from patients’ perspectives, problematic. They document that life‐threateningly ill patients overestimate the chance of cure (Catt et al, 2011; Gad et al, 2018) and misconceive what trial participation involves (Kimmelman, 2017; Miller & Joffe, 2008; Pentz et al, 2012). Thus, as Jain writes about phase 3 oncology trials, phase 1 trials ‘ghost’ the lives, death, and suffering of the majority of patients, who will never benefit from trial participation (Jain, 2010; Plutynski forthcoming).…”

Section: Introductionmentioning

confidence: 99%

Precision patients: Selection practices and moral pathfinding in experimental oncology

Dam

Green

Bogicevic

et al. 2022

Sociology Health & Illness

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This paper addresses selection practices in a Danish phase 1 unit specialised in precision medicine in the field of oncology. Where precision medicine holds the ambition of selecting genetically fit medicine for the patient, we find that precision medicine in the early trial setting is oriented towards selecting clinically and genetically fit patients for available treatment protocols. Investigating how phase 1 oncologists experience and respond to the moral challenges of selecting patients for early clinical trials, we show that inclusion criteria and patient categories are not always transparent to patients. Lack of transparency about inclusion criteria has been interpreted as morally problematic. Yet drawing on social science studies of ‘unknowing’, we argue that silence and non‐transparency in interactions between oncologists and patients are crucial to respect the moral agency of patients at the edge of life and recognise them as belonging to the public of Danish health care. In the discussion, we consider the practice of placing ‘unfit’ patients on a waiting list for trial participation. Rather than representing an ethical and political problem, we argue, the waiting list can act as a valve enabling oncologists to navigate the scientific and as well as the moral uncertainties in phase 1 oncology.

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Patient information in phase 1 trials: A systematic review

Cited by 6 publications

References 69 publications

Identifying patient values impacting the decision whether to participate in early phase clinical cancer trials: A systematic review

Identifying patient values impacting the decision whether to participate in early phase clinical cancer trials: A systematic review

Before Consent: Qualitative Analysis of Deliberations of Patients With Advanced Cancer About Early-Phase Clinical Trials

Precision patients: Selection practices and moral pathfinding in experimental oncology

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