The MIR Trial: lessons learned from conducting a Clinical Trial of an Investigational Medicinal Product (CTIMP) in general practices

The problem
Mental health is increasingly being recognised as a major issue for the NHS and Government in the UK. Between 5 and 10% of people experience depression at any one time and the first line of treatment is usually an antidepressant prescribed by their general practitioner, such as a Selective Serotonin Reuptake Inhibitor (SSRI), eg Citalopram, Fluoxetine, or a Serotonin and Noradrenaline Reuptake Inhibitor (SNRI), eg Venlafaxine. After six weeks of treatment, however, approximately 50% of patients treated with these antidepressants are still experiencing depressive symptoms.

In the MIR Trial, we aimed to determine the effectiveness of the addition of Mirtazapine in reducing symptoms of depression compared with a placebo, in patients who are already taking an SSRI or SNRI. We will explore the challenges we have experienced as a research team and describe some of the lessons we have learned while working with general practices on this multi-site clinical trial of an investigational medicinal product (CTIMP).
The approach
MIR is a pragmatic, double blind, randomised controlled trial. As one of four trial sites, the University of Exeter Medical School was able to recruit up to 24 general practices in Devon, and had a target of 120 for patient recruitment. The research team was responsible primarily for recruiting practices, conducting patient baseline assessments (including taking informed consent) and follow-up appointments, reissuing patients’ MIR medication and maintaining both practice and patient involvement in the study. Participating practices had three broad areas of responsibility: identification of potential participants (through direct referrals and a search of their computerised medical records system), handling of the trial medication, and a small amount of administration.
Findings
The Exeter study team faced a range of challenges throughout this trial, starting with the initial set up of the project. In particular, the challenges included (i) working collaboratively with other trial sites, (ii) maintaining effective relationships with general practices, (iii) sustaining and supporting individual patient participation in the study over a long period of time (up to 52 weeks), (iv) working on a study involving an investigational medicinal product. We will discuss these challenges in more detail, and describe both the lessons learned and how they may be applied to other trials in primary care.
Consequence
Our experience suggests that it is possible to successfully address the challenges associated with conducting a CTIMP in general practices. By maintaining effective strategies for communication with general practice staff and all participants, and implementing some pragmatic measures, excellent rates of patient recruitment and retention can be achieved.