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Putting participants and study partners FIRST when clinical trials end early.

ABSTRACT: Between 2018 and 2019, multiple clinical trials ended earlier than planned, resulting in calls to improve communication with and support for participants and their study partners ("dyads"). The multidisciplinary Participant Follow-Up Improvement in Research Studies and Trials (Participant FIRST) Work Group met throughout 2021. Its goals were to identify best practices for communicating with and supporting dyads affected by early trial stoppage. The Participant FIRST Work Group identified 17 key recommendations spanning the pre-trial, mid-trial, and post-trial periods. These focus on prospectively allocating sufficient resources for orderly closeout; developing dyad-centered communication plans; helping dyads build and maintain support networks; and, if a trial stops, informing dyads rapidly. Participants and study partners invest time, effort, and hope in their research participation. The research community should take intentional steps toward better communicating with and supporting participants when clinical trials end early. The Participant FIRST recommendations are a practical guide for embarking on that journey.

SUBMITTER: Largent EA

PROVIDER: S-EPMC9926498 | biostudies-literature | 2022 Dec

REPOSITORIES: biostudies-literature

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Putting participants and study partners FIRST when clinical trials end early.

Largent Emily A EA Walter Sarah S Childs Nancy N Dacks Penny A PA Dodge Shana S Florian Hana H Jackson Jonathan J Llibre Guerra Jorge J JJ Iturriaga Erin E Miller David S DS Moreno Monica M Nosheny Rachel L RL Obisesan Thomas O TO Portacolone Elena E Siddiqi Bernadette B Silverberg Nina N Warren Rueben C RC Welsh-Bohmer Kathleen A KA Edelmayer Rebecca M RM

Alzheimer's & dementia : the journal of the Alzheimer's Association 20220802 12

Between 2018 and 2019, multiple clinical trials ended earlier than planned, resulting in calls to improve communication with and support for participants and their study partners ("dyads"). The multidisciplinary Participant Follow-Up Improvement in Research Studies and Trials (Participant FIRST) Work Group met throughout 2021. Its goals were to identify best practices for communicating with and supporting dyads affected by early trial stoppage. The Participant FIRST Work Group identified 17 key ...[more]

PMID: 35917209

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Project description:BackgroundHousing First has become a popular treatment model for homeless adults with mental illness, yet little is known about program participants' early experiences or trajectories. This study used a mixed methods design to examine participant changes in selected domains 6 months after enrollment in a Canadian field trial of Housing First.MethodsThe study sample included 301 participants receiving the Housing First intervention at the Toronto site of the At Home/Chez Soi project. This study used a pre-post design to compare quantitative 6-month outcome data to baseline values in key domains and multivariate regression to identify baseline demographic, clinical or service use variables associated with observed changes in these domains. In addition, qualitative data exploring participant and service provider perspectives and experiences was collected via stakeholder interviews and focus groups, and analyzed using thematic analysis.ResultsThe majority (60 to 72%) of participants followed the expected trajectory of improvement, with the remaining experiencing difficulties in community integration, mental health symptom severity, substance use, community functioning and quality of life 6 months after program enrollment. Diagnosis of psychotic disorder was associated with a reduction in quality of life from baseline to 6-months, while substance use disorders were associated with reduced mental illness symptoms and substance use related problems and an improvement in quality of life. Participants housed in independent housing at 6-months had greater improvements in community integration and quality of life, and greater reduction in mental illness symptoms, compared to those not independently housed. The quality of the working alliance was positively associated with improvements in physical and psychological community integration and quality of life. Qualitative data provided a unique window into the loneliness and isolation experienced by Housing First participants, as well as problems related to substance use and a need for life skills training and support.ConclusionsAdditional strategies can help support Housing First participants in the early stages of program participation and address potential causes of early difficulties, including lack of life skills and social isolation. This study highlights the importance of early and ongoing evaluation, monitoring and program adaptations to address consumer support needs.Trial registrationCurrent Controlled Trials ISRCTN42520374.

Project description:ObjectivesIf patients are to reap the benefits of continued drug development, an understanding of why healthy participants take part in phase I clinical trials is imperative. The current study aimed to explore the nature of these underlying motivations which may, in turn, improve the overall participant experience and assist in the development of more effective recruitment and retention strategies.DesignThis study used a qualitative design based on the theory of planned behaviour. Specifically, it explored healthy participants' underlying behavioural, control and normative beliefs which influence their participation in phase I clinical trials.SettingThis study took place at a company that specialises in conducting phase I and phase II clinical trials in the Australian state of Queensland.ParticipantsParticipants (n=31) were either currently undergoing a phase I clinical trial or had previously taken part in a phase I clinical trial.ResultsResults showed that the motivations were varied and not solely centred on financial gains. Reported advantages of participation included altruism, while inconvenience was most often reported as a disadvantage. Friends were reported as those most likely to approve, while one's mother was reported as most likely to disapprove. Having a suitable time frame/flexible scheduling and feeling comfortable taking part in the trial were both the most commonly reported facilitators, while inflexible scheduling/time commitment was the most commonly reported barrier.ConclusionsPractical implications included the need for organisations involved in clinical trials to be mindful of inflexible scheduling and exploring the possibility of making educational materials available to family members who may be concerned about the risks associated with participation. Overall, it is anticipated that the results of this study will improve the understanding of factors that influence phase I clinical trial participation which may, ultimately, help develop new therapeutics to improve patient health.

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Putting participants and study partners FIRST when clinical trials end early.

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Putting participants and study partners FIRST when clinical trials end early.

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