New Module – Clinical Trials Management

Clinical Trials Management‘ Module: The New Kid on the Blog

If only I had a penny for every time someone asked me “Why exactly does one need a trial manager (or trial management)? Isn’t it sufficient to just have an idea and some money and to crack on with it?”

There are several steps, little and large, in taking a trial project from scientific question to publication and good trial management can make the difference between success and failure.  The success of a building project is measured by delivery on schedule and on budget, and it is easy to see how important the role of the project manager is in that success. Trial management can be likened to building project management, taking the ideas of the architect or the investigator through to a finished building or, in this case, a successfully completed trial, where the main measures of success are also quality, time and money.

A good way to think about what makes a trial manager ‘successful’, would be to picture someone who is a project manager but also is also essentially a researcher, contributing to the question and helping answer it.  As my boss very aptly put it, ‘a cross between Alan Sugar and Brian Cox’! The hat of ‘trial manager’ may be worn by an investigator or someone employed to wear it, depending on the size and financial constraints of the project.

Contributing to and updating a GCP*-compliant protocol, preparing regulatory submissions and organising approvals, administering the study budget, training and initiating study sites, making and implementing a recruitment plan, reporting on the status of the project to stakeholders, monitoring data quality, communicating with sites and troubleshooting, safety reporting, coordinating amendments, quality control on the conduct of the trial, site closeout and archiving; these may seem like a mouthful of jargon, but are just some of the elements necessary to ensure smooth running of a clinical trial.

The new module will focus on the operational life-cycle of a study and equip participants with practical tools to run clinical trials on a day-to-day basis. It is being delivered by an experienced team of statisticians, systems and data managers, and trial coordinators from the Primary Care Clinical Trials Unit, and is aimed at investigators, as well as budding and aspiring trial managers.

With it being a new module, while there will be a core curriculum, we would like to make it as relevant and useful to participants as possible – tell us what aspects of trial management you would like to see covered in the programme, make suggestions for course contributors, bring us your case studies. We promise to put it all together into an exciting and engaging format and hope to see you at the course!