Development and Initial Implementation of a Clinical Monitoring Strategy in a Non-regulated Trial: a research note from the ReStOre II Trial.

Background: Data and Safety Monitoring is integral to quality assurance of clinical trials. Although monitoring is a core legal component of regulated clinical trials, non-regulated trials are not mandated to incorporate monitoring. Consequently, the monitoring process has been underutilised and underreported in this setting. This research report outlines the development and plans for implementing a bespoke Clinical Monitoring Strategy within the ' Rehabilitation Strategies Following Oesophagogastric and Hepatopancreaticobiliary Cancer (ReStOre II) Trial', a non-regulated trial comparing a 12-week multidisciplinary programme of rehabilitation to standard care in a cohort of 120 cancer survivors. Methods: This research note provides a detailed overview of the ReStOre II Clinical Monitoring Strategy and describes the development of the strategy pre and post awarding of the grant. The strategy consists of the establishment and implementation of a comprehensive trial governance structure, inclusive of a Trial Management Group, Trial Steering Committee Meeting, and Independent Data Monitoring Committee. In addition, external trial monitoring by the Clinical Research Facility at St James's Hospital. Three monitoring visits will be conducted during the trial; i) site initiation visit, ii) interim monitoring visit, and iii) close our visit. Results: The Clinical Monitoring Strategy has been finalised and is currently being implemented within the ReStOre II Trial. Two site initiation visits and one interim monitoring visit have been completed to date. Conclusion: This research note provides a template for implementation of a Clinical Monitoring Strategy in a non-regulated clinical trial. Registration: ReStOre II Trial: https://clinicaltrials.gov/ct2/show/NCT03958019.

Patient and public involvement in numerical aspects of trials: a mixed methods theory-informed survey of trialists' current practices, barriers and facilitators.

OBJECTIVE: We aimed to find out if trialists involve patients and the public in numerical aspects of trials, how and what are the barriers and facilitators to doing it. DESIGN: We developed a survey based on the Theoretical Domains Framework. We used a mixed methods approach to analyse the data and to identify important domains. SETTING: Online survey targeting UK-based trial units. PARTICIPANTS: Stakeholders working in UK-based clinical trials, 18 years old or over, understand English and agree to take part in the study. OUTCOME MEASURES: Trialists' behaviour of involving patients and the public in numerical aspects of trials and its determinants. RESULTS: We included 187 respondents. Majority were female (70%), trial managers (67%) and involved public and patient partners in numerical aspects of trials (60%). We found lack of knowledge, trialists' perception of public and patient partners' skills, capabilities and motivations, scarce resources, lack of reinforcement, and lack of guidance were barriers to involving public and patient partners in numerical aspects of trials. Positive beliefs about consequences were an incentive to doing it. CONCLUSIONS: More training, guidance and funding can help trialists involve patient and public partners in numerical aspects, although they were uncertain about public and patient partners' motivation to be involved. Future research should focus on identifying public and patient partners' motivations and develop strategies to improve the communication of numerical aspects.