The life of a Trial Manager

CTU_RGB ‘So, what is it that you actually do?’ It’s inevitable that I’m asked that question as soon as I tell anyone that my job is that of a Trial Manager. I’ve had numerous extended conversations with family members and friends as well as new acquaintances, all unable to fathom exactly what it is I do during my working hours.  Sometimes I ask myself the same question.

Trial Management is akin to project management, there are so many pieces of thread to hold together and to release at just the right moment that seeing those individual threads blossom into the bigger picture can sometimes take a while.

My current project; TOAST (Treatment Options without Antibiotics for Sore Throat), is a multicentre, double blind randomized placebo-controlled trial. In plain English, this means it’s a large trial running in a number of places involving a number of researchers and potential participants and none of us know which treatment the participants will receive – my job is to make sure that the all of these elements come together at the right time (and within budget!).

A Trial Manager will be involved in all aspects of the project, the whole way through. Liaising with the Chief Investigator (that’s the clinician in charge) and other co-investigators (in the case of TOAST that’s another ten people) to get the Protocol in place to start with can be the first, and sometimes the most difficult, hurdle to leap. Following on from that Ethics committee applications, MHRA applications, NHS Research and Development applications, sourcing medication, designing information leaflets, consent forms, symptom diaries and recruitment forms for researchers – all before you can even think about where you might find people willing to participate in the trial itself.

Here, we work within the Primary Care setting, so working to get GPs on board to recruit participants into the trial is key to the success of any project. Maintaining good relationships with these GPs throughout the course of the trial also makes it easier when there are tricky conversations to be had (such as discussing the recruitment of an ineligible participant, or asking them to complete information urgently). A good Trial Manager will know ‘their’ GPs and nurses and understand the best way in which to get the best for the trial from them.

Once the trial actually opens to recruitment a Trial Manager tends to take on the form of a slightly obsessed post room stalker. Any indication that a new consent form or follow up diary has arrived within the department provides them with an almost delirious state! Every recruit counts. The Trial Manager lives and breathes every notification of a new participant and can often be seen doing what can only be described as a ‘new recruit dance’ whenever they find that a new person has entered their trial.

Completing recruitment and moving towards analysis of the results and ultimate publication is the final fanfare, the prospect of which I’m looking forward to as we near the end of TOAST.

Being a Trial Manager is like being a parent and the trial the child. You pour your dedication, affection and time into making the trial a real achievement for all involved; seeing it grow into a successful piece of research fills you with a sense of pride that you have nurtured it through the tough times and out through the other side.

Julie Allen
Infectious Disease Trial Manager, Primary Care Clinical Trials Unit, Nuffield Department of Primary Care Health Sciences

 

One comment on “The life of a Trial Manager

  1. Dear Julie Allen,

    I am a clinical pharmacologist working in Bellvitge University Hospital in Barcelona (http://www.bellvitgehospital.cat/en_index.html).

    In addition to my work in the clinical pharmacology service (http://www.bellvitgehospital.cat/medical-services/) I teach clinical pharmacology at the Universitat de Barcelona (http://www.ub.edu/web/ub/en/index.html) as Associate Professor.

    To learn several key concepts about clinical trials I recommend to my students your paper published in Trials 2014 (in the Study Protocol section of the journal):

    “Oral corticosteroid use for clinical and cost-effective symptom relief of sore throat: study protocol for a randomized controlled trial” Cook J, Hayward G, Thompson M, et al. Trials 2014, 15:365.

    In addition, as a practical activity we will do a review of several key aspects of the informed consent process in clinical trials, including the informed consent form and the participant information sheet. It would be very interesting to review these documents from your trial (TOAST) … to make de discussion “more real” and useful.

    In this context, ¿would it be possible to have and to use these documents in our teaching activities?, and ¿How could I achive these documents?

    Many thanks in advance for your attention.

    Sincerely yours,

    Jose M Arnau
    Clinical Pharmacology Service
    Bellvitge University Hospital
    Hospitalet de Llobregat
    Barcelona

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