PRIMENT Clinical Trials Unit is a collaboration between UCL Research Departments of Primary Care & Population Health and Mental Health Sciences and the MRC General Practice Research Framework (GPRF). The unit coordinates and runs RCTs and other large studies.
The UCL academic collaboration has existed for over 15 years and consists of multidisciplinary teams including clinical researchers in psychiatry, primary care, psychology, palliative care, nursing, epidemiology, trial management and statistics. Over the years this group has conducted clinical trials and other large studies on severe mental illnesses, common mental disorders (i.e. depression and anxiety disorders) and other common clinical conditions in primary care. Many studies have been conducted in collaboration with the MRC GPRF and links have been further strengthened by the appointment of Professor Irwin Nazareth to the Directorship of the MRC GPRF in 2005. He is also the Head of the Research Department of Primary Care & Population Health at UCL.
The strategic direction of the Unit has evolved from the research activities undertaken by the collaboration and includes the evaluation of cognitive and behaviour therapy and other intervention for depression in primary care, smoking cessation interventions, care packages for severe mental illnesses in primary care, the use of self management programmes in people with osteoarthritis, evaluation of common treatments in primary care, educational interventions for general practitioners on the implementation of treatments, rational prescribing and others as listed under publications.
The existing organizational structure within PRIMENT ensures continuity of the disciplines. The UCL collaboration is organized into topic specific teams i.e. mental health including severe mental illnesses and common mental disorders, e-health, dementias and methodology. Each team is multidisciplinary and supported by administrative staff.
The GPRF has four distinct teams: the quality assurance nursing team, the trial management team, the administrative team that works on database development, data management, finance and contractual matters, and the epidemiological and statistical team that work collaboratively with the UCL group and the MRC Biostatistics Unit on statistical aspects of protocol development and data analyses. Collaborative training occurs between statisticians and epidemiologists, facilitated through various statistical methodologies support groups. Each team is led by a senior staff member who ensures long term continuity of the work within their core disciplines. All team members are involved in most aspects of the trials/studies. This includes the development of research ideas, preparation of grant applications, recruitment, study management, long term follow up and data management.
The study team develops study specific standard operating procedures (SOP) at the start of each new study. This process ensures continuity should staff leave and be replaced by new members.
All the senior clinicians (i.e. doctors and nurses), statisticians, epidemiologists and senior managers working at the GPRF and UCL are supported by core MRC or higher education institute funds respectively. The trial coordinators and trial management staff are employed on grant income specifically earned for the conduct of studies.
