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

Gorini, Alessandra; Mazzocco, Ketti; Pravettoni, Gabriella

doi:10.1159/000441559

Cited by 5 publications

(6 citation statements)

References 61 publications

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“… 2014 A systematic review of barriers and facilitators to minority research participation among African Americans, Latinos, Asian Americans, and Pacific Islanders The focus is on health research in general, rather than on CT exclusively (as the type study where potential participants were invited to participate). Gorini, A [ 86 ]. 2015 Decision-Making Process Related to Participation in Phase I Clinical Trials: A Nonsystematic Review of the Existing Evidence It is a nonsystematic review and just three barriers are mentioned, and no facilitators.…”

Section: Resultsmentioning

confidence: 99%

Barriers and facilitators to the participation of subjects in clinical trials: An overview of reviews

Rodríguez-Torres

González-Pérez

Díaz-Pérez

2021

Contemporary Clinical Trials Communications

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Background The demand for clinical trial participants is today one of the highest it has ever been and continues to increase. At the same time, subject recruitment continues to be problematic and the major reason for clinical trial premature terminations. The literature on clinical trial recruitment, which spans several decades and includes hundreds of studies, has an abundance of findings that can be synthesized by way of an overview to provide a well-informed and complete picture of the factors that determine subject participation. Objectives An overview of the systematic reviews that report barriers and facilitators to clinical trial participation was conducted. The extracted data were synthesized, and a thematic framework of the factors that affect subject participation in clinical trials was developed. The overview extended across medical subjects and demographics. Methods Thirty reviews that complied with the inclusion criteria were included. These reviews covered 753 relevant primary studies and reported 881 barriers and facilitators. The barriers and facilitators were thematically synthesized and a thematic framework of 20 themes was developed. The quality of the included reviews was assessed and reported. Main results Several opportunities to increase clinical trial participation, by developing interventions and changing the trial design, derived from an analysis of the thematic framework. That analysis also showed that most of the 20 themes operate mainly as a barrier or as a facilitator, and that most have an effect across medical subjects. As to the quality elements assessed, some reviews complied almost fully but most only partially.

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Section: Resultsmentioning

confidence: 99%

Barriers and facilitators to the participation of subjects in clinical trials: An overview of reviews

Rodríguez-Torres

González-Pérez

Díaz-Pérez

2021

Contemporary Clinical Trials Communications

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“…Across different domains, important regularities appear in the mechanisms through which emotions in uence judgments and choices. 33,34 So increased awareness of emotions may help putting them to best use and reduce their in uence as a bias in shared decisions. 35 Our study con rms that it is still necessary to improve and implement the culture of shared decisionmaking in oncology.…”

Section: Discussionmentioning

confidence: 99%

Knowledge and Attitudes Towards Clinical Trials Among Women with Ovarian Cancer: Results of The Acto Study

Mosconi¹,

Roberto²,

Cerana³

et al. 2021

Preprint

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BackgroundAlthough there are several initiatives by research groups, regulatory authorities, and scientific associations to engage citizens/patients in clinical research, there are still obstacles to participation. Among the main discouraging aspects are incomplete understanding of the concepts related to the clinical trial, and the scant, sometimes confused, explanations given. The aim of this observational, cross-sectional multicenter study is to investigate knowledge, attitudes and trust in clinical research.We conducted a survey among women with ovarian cancer at their first follow-up visit or first therapy session, treated in centers belonging to the Mario Negri Gynecologic Oncology (MaNGO) and Multicenter Italian Trials in Ovarian Cancer (MITO) groups. A questionnaire on knowledge, attitudes and experience was assembled ad hoc after a literature review and a validation process involving patients of the Alliance against Ovarian Cancer (ACTO).ResultsFrom 25 centers 348 questionnaire were collected; 73.5% of responders were 56 years or older, 54.8% had a high level of education, more than 80% had no experience of trial participation. Among participants 59% knew what clinical trials are and 71% what the informed consent is. However more than half did not know the meaning of the term randomization. More than half (56%) were in favor of participating in a clinical trial, but 35% were not certain. Almost all responders acknowledged the doctor’s important role in decision-making. Patients associations were recognized as playing a powerful role in the design and planning of clinical trials. ConclusionsThis study helps depict the knowledge and attitudes of women with ovarian cancer in relation to clinical trial, suggesting initiatives aimed at improving trials’ culture, literacy and compliance, and fresh ways of communication between doctors and patients.

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“…In previous studies of EP enrollment, ethicists examined consenting discussions, with a focus on patient understanding, expectations for experimental treatment, and dilemmas associated with therapeutic misconceptions. 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: 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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Decision-Making Process Related to Participation in Phase I Clinical Trials: A Nonsystematic Review of the Existing Evidence

Cited by 5 publications

References 61 publications

Barriers and facilitators to the participation of subjects in clinical trials: An overview of reviews

Barriers and facilitators to the participation of subjects in clinical trials: An overview of reviews

Knowledge and Attitudes Towards Clinical Trials Among Women with Ovarian Cancer: Results of The Acto Study

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

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