Trial Management

Trial Management: leading on trial delivery from inception to dissemination.

Introduction

Trial management is the project management of clinical research.

The trial management team are at the core of any clinical trial. They are responsible for the day-to-day management of a clinical trial/study, as well as overall project management ensuring that studies are delivered to time and target. This means working to ensure that enough participants are recruited, and that the data collected is of a high quality. Core activities include development of the study protocol and vital study documentation as well as coordination of research governance and regulatory submissions. Not only does the trial management team ensure everything is in place to collect data to answer the research question, but they are also the key liaison for all the different groups working to make a trial happen.

The trial management team

We are a team of approximately 50 Research Associates/Trial Managers and Research Fellows/Seniors Trial Managers working across a range of disease areas (Link to CTR divisions page - Cancer; Brain Health and Mental Wellbeing; Infections, Inflammation & Immunity; Population Health and Social Care) with a wealth of experience in delivering a wide range of study types. Examples include medicines (Clinical Investigations of Investigational Medicinal Products (CTIMPS)), complex interventions, medical devices, mechanisms of disease and treatment, and cohort studies. Our studies occur across all phases of clinical research from early phase and feasibility studies through to late phase large national and international randomised controlled trials.

Why trial management is important for research studies

Trial management teams are the lynch pin to the overall design, delivery and management of a study. The team provides expertise in all aspects of project management, including trials methodology, research governance, ethics, contracting and finance. These skills are vital to ensure research studies are delivered to the highest quality standards within time and budget. They are a key contact within the multi-disciplinary team, liaising with clinicians, other researchers, patient representatives, research institutions and research sites.

The trial management team are key in generating creative solutions to complex problems to ensure the delivery of trials run smoothly and efficiently.

The video Working in clinical trial management showcases the important role that trial managers play in health research.

How trial management fits into the study lifecycle

The role of the trial manager is pivotal to the success of any clinical research and starts at the very beginning of the study lifecycle. We work with chief investigators and other core members of the trial team to develop studies and trials to answer a specific research question. We then continue to be involved through the set up and delivery, right through to the closure of a trial. Trial managers also play an important role in publishing the results of a trial, not only to other researchers, but to members of the public and importantly those people that took part in the trial. In some instances, this may include work that will inform policy and changes in clinical (and other) practices.

Guiding principles/methodology

Central to the trial manager role is ensuring that trials and studies are delivered to quality standards, and within regulatory and ethical frameworks e.g. Guidelines for Good Clinical Practice.

We are a Trial Forge Centre using trial methodology research to improve trial efficiency building the evidence for what we do and why.

Unique expertise in the team

We have a breadth of expertise in the team working across the CTR portfolio. Our trial managers have a variety of scientific and other professional training and research experience. This provides broad flexibility that enables us to provide the very best people to deliver the trials we coordinate.