Doing trials within trials: a qualitative study of stakeholder views on barriers and facilitators to the routine adoption of methodology research in clinical trials

BACKGROUND Conventional clinical trials are essential for generating high-quality evidence by measuring the efficacy of interventions in rigorously controlled clinical environments. However, their execution can be expensive and time-consuming. In addition, clinical trials face several logistical challenges regarding the identification, recruitment, and retention of participants; consistent data collection during trials; and adequate patient follow-up. This might lead to inefficient resource utilization. In order to partially address the current problems with conventional clinical trials, there exists the need for innovations. One such innovation is the virtual clinical trial (VCT). VCTs allow for the collection and integration of diverse data from multiple information sources, such as electronic health records, clinical and demographic data, patient-reported outcomes, anthropometric and activity measurements, and data collected by digital biomarkers or (small) samples that participants can collect themselves. Although VCTs have the potential to provide substantial value to clinical research and patients because they can lower clinical trial costs, increase the volume of data collected from patients’ daily environment, and reduce the burden of patient participation, so far VCT adoption is not commonplace. OBJECTIVE This paper aims to better understand the barriers and facilitators to VCT adoption by determining the factors that influence individuals’ considerations regarding VCTs from the perspective of various stakeholders. METHODS Based on online semistructured interviews, a qualitative study was conducted with pharmaceutical companies, food and health organizations, and an applied research organization in Europe. Data were thematically analyzed using Rogers’ diffusion of innovation theory. RESULTS A total of 16 individuals with interest and experience in VCTs were interviewed, including persons from pharmaceutical companies (n=6), food and health organizations (n=4), and a research organization (n=6). Key barriers included a potentially low degree of acceptance by regulatory authorities, technical issues (standardization, validation, and data storage), compliance and adherence, and lack of knowledge or comprehension regarding the opportunities VCTs have to offer. Involvement of regulators in development processes, stakeholder exposure to the results of pilot studies, and clear and simple instructions and assistance for patients were considered key facilitators. CONCLUSIONS Collaboration among all stakeholders in VCT development is crucial to increase knowledge and awareness. Organizations should invest in accurate data collection technologies, and compliance of patients in VCTs needs to be ensured. Multicriteria decision analysis can help determine if a VCT is a preferred option by stakeholders. The findings of this study can be a good starting point to accelerate the development and widespread implementation of VCTs.

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A qualitative study of barriers and facilitators to enrollment of adolescents and young adults onto cancer clinical trials at NCI community oncology research program (NCORP) sites.

Journal of Clinical Oncology ◽

10.1200/jco.2020.38.15_suppl.e19050 ◽

2020 ◽

Vol 38 (15_suppl) ◽

pp. e19050-e19050 ◽

Cited By ~ 1

Author(s):

Elizabeth Siembida ◽

Holli Ann Loomans-Kropp ◽

Irene Tami-Maury ◽

Lillian Sung ◽

Brad H. Pollock ◽

...

Keyword(s):

Clinical Trials ◽

Young Adults ◽

Qualitative Interviews ◽

Community Setting ◽

Barriers And Facilitators ◽

Adolescents And Young Adults ◽

Cancer Clinical Trials ◽

Stakeholder Views ◽

Oncology Research ◽

The Impact

e19050 Background: Cancer clinical trials (CCTs) contribute to improving patient survival and quality of life; however, adolescents and young adults (AYAs, 15-39 years old), are underrepresented in CCTs, especially in the community setting. We aimed to identify barriers and facilitators to AYA CCT enrollment in the NCORP. Methods: We conducted 43 one-on-one semi-structured qualitative interviews with key stakeholders involved in the enrollment of AYAs across a diverse group of NCORP primary (n = 5) and affiliate (n = 10) sites. Interviews were conducted remotely by 3 trained interviewers using the Zoom platform. Stakeholders were recruited from high and low AYA enrolling sites (AYA/total site enrollments > 10% and < 3%, respectively). Stakeholders were overall NCORP Site PIs (n = 5), lead NCORP administrators (n = 4), clinical research associates (n = 11), medical and pediatric oncologists involved in the enrollment of AYAs (n = 7), regulatory research associates (n = 5), nurse navigators (n = 6), and patient advocates (n = 5). Interviews were audiotaped and transcribed. Thematic analysis was conducted to identify themes and relate them back to our primary research questions regarding barriers and facilitators to AYA CCT enrollment. Results: Stakeholder views on enrollment barriers centered on 5 main themes: (1) lack of site-level prioritization or discussion of AYA enrollment; (2) limited number of clinical trials for AYAs available nationally, with few trials opened locally; (3) insufficient resources and research staff; (4) concerns about the cost effectiveness of opening AYA trials due to low numbers of eligible patients; and (5) patient misconceptions about CCTs. Stakeholder views on enrollment facilitators centered on 3 main themes: (1) presence of an AYA program focused on increasing enrollment; (2) having a designated site AYA “champion”; and (3) having site leadership identify AYA enrollment as a priority. Stakeholders agreed that incentivizing AYA enrollments via increased reimbursement and/or study credits could potentially lead to increased enrollment. Conclusions: In addition to identifying multiple shared barriers to AYA CCT enrollment, our study also identified possible interventions for enrollment improvement, including designation of AYA “champions”, increased reimbursement for AYA enrollments, and improving AYA’s understanding of CCTs. Further studies are needed to assess the impact of interventions aimed at increasing AYA enrollment across the NCORP.

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Stakeholder Perspectives on Barriers and Facilitators for the Adoption of Virtual Clinical Trials: Qualitative Study

Journal of Medical Internet Research ◽

10.2196/26813 ◽

2021 ◽

Vol 23 (7) ◽

pp. e26813

Author(s):

Romée Melanie Helena Coert ◽

James Kenneth Timmis ◽

André Boorsma ◽

Wilrike J Pasman

Keyword(s):

Clinical Trial ◽

Clinical Trials ◽

Data Collection ◽

Qualitative Study ◽

Research Organization ◽

Barriers And Facilitators ◽

Pharmaceutical Companies ◽

Health Organizations ◽

Activity Measurements ◽

Patient Reported

Background Conventional clinical trials are essential for generating high-quality evidence by measuring the efficacy of interventions in rigorously controlled clinical environments. However, their execution can be expensive and time-consuming. In addition, clinical trials face several logistical challenges regarding the identification, recruitment, and retention of participants; consistent data collection during trials; and adequate patient follow-up. This might lead to inefficient resource utilization. In order to partially address the current problems with conventional clinical trials, there exists the need for innovations. One such innovation is the virtual clinical trial (VCT). VCTs allow for the collection and integration of diverse data from multiple information sources, such as electronic health records, clinical and demographic data, patient-reported outcomes, anthropometric and activity measurements, and data collected by digital biomarkers or (small) samples that participants can collect themselves. Although VCTs have the potential to provide substantial value to clinical research and patients because they can lower clinical trial costs, increase the volume of data collected from patients’ daily environment, and reduce the burden of patient participation, so far VCT adoption is not commonplace. Objective This paper aims to better understand the barriers and facilitators to VCT adoption by determining the factors that influence individuals’ considerations regarding VCTs from the perspective of various stakeholders. Methods Based on online semistructured interviews, a qualitative study was conducted with pharmaceutical companies, food and health organizations, and an applied research organization in Europe. Data were thematically analyzed using Rogers’ diffusion of innovation theory. Results A total of 16 individuals with interest and experience in VCTs were interviewed, including persons from pharmaceutical companies (n=6), food and health organizations (n=4), and a research organization (n=6). Key barriers included a potentially low degree of acceptance by regulatory authorities, technical issues (standardization, validation, and data storage), compliance and adherence, and lack of knowledge or comprehension regarding the opportunities VCTs have to offer. Involvement of regulators in development processes, stakeholder exposure to the results of pilot studies, and clear and simple instructions and assistance for patients were considered key facilitators. Conclusions Collaboration among all stakeholders in VCT development is crucial to increase knowledge and awareness. Organizations should invest in accurate data collection technologies, and compliance of patients in VCTs needs to be ensured. Multicriteria decision analysis can help determine if a VCT is a preferred option by stakeholders. The findings of this study can be a good starting point to accelerate the development and widespread implementation of VCTs.

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