Exploring the role and functionality of trial steering committees
نویسندگان
چکیده
Background Independent oversight of clinical trials, recommended by Good Clinical Practice, is typically provided by an independent advisory Data Monitoring Committee (DMC) and an independent executive committee, to whom the DMC make recommendations. The detailed role and functionality of this executive committee, known as the Trial Steering Committee (TSC) have not been studied since proposed by the MRC.
منابع مشابه
An ethnographic study of group decision making to understand and improve how trial steering committees contribute to trial conduct
Methods Using ethnographic methods, we are exploring how TSCs make decisions regarding trial conduct in a purposive sample of trials across registered trials units in the UK, selected to represent a range of trial designs, interventions and oversight structures. Non-participatory observation of TSCs will be triangulated by follow-up interviews with committee members and evaluations of trial doc...
متن کاملReporting remit and function of trial steering committees in randomised controlled trials: review of published literature
Background DAMOCLES established a Data Monitoring Committee (DMC) Charter which has been widely used for RCTs. The DMC is typically advisory and makes recommendations to another executive body; the Trial Steering Committee (TSC). Despite the executive role of the TSC over the DMC, the CONSORT statement doesn’t explicitly require reporting of TSC activity although TSCs are included as an example...
متن کاملEnhancing public involvement in trial oversight committees through qualitative research with eight trials facing challenges
Background Trial oversight committees (TOC) including Trial Steering Committees (TSCs) and Trial Management Groups (TMGs) are integral to trial conduct. Patient and public involvement (PPI) in trial design and conduct is frequently stipulated although there is little empirical evidence to optimise roles and inputs. We aimed to use qualitative research to understand the experiences of PPI involv...
متن کاملTrial steering committees for randomised controlled trials: updating and redeveloping guidance and terms of reference informed by current practice and experience
The DAMOCLES project established a Data Monitoring Committee Charter which has been widely used for randomised controlled trials since 2005. As established within DAMOCLES, the DMC is typical advisory, making recommendations to another executive body; considered the Trial Steering Committee. No evidence-based Charter exists for TSCs to establish their role and functionality in RCTs. The MRC Gui...
متن کاملRemits, roles and working models for trial steering committees and data monitoring committees in studies evaluating diagnostic tests: a survey of current practice
Background All clinical trials that involve the prospective study of patients need some form of independent monitoring. For RCTs of therapeutic interventions, UK public funders of research – including the MRC – require an independent trial steering committee (TSC) to oversee management and finances, and a data monitoring committee (DMC) to oversee study progress and accumulating study data. Thi...
متن کامل