What are the barriers and facilitators when conducting CTIMPs in a primary care setting: experiences and lessons from the PROPS trial.

Research to improve primary care services should be performed in primary care settings. Too often, such studies are carried out in specialist settings such as hospitals, particularly when they involve a drug trial. In part, this reflects the difficulties of carrying out such studies in a primary care setting, especially at a time when resources are in short supply and the primary care workforce is in crisis. The PROPS trial is an on-going drug trial based in general practices, and has struggled to recruit patients. PROPS is investigating the use of a capsule containing three different types of medication (a ‘polypill’) for people who have suffered a stroke. The aim of these treatments is to reduce the chance of having another stroke.

This case study of the PROPS trial will explore the difficulties of conducting drug trials in a primary care setting. We will look at aspects of the study design, navigating the regulatory framework, setting-up the trial in general practices, and recruiting participants.

To do this we will interview the key people involved in the conduct of the study, including members of the research team, clinical staff, regulatory and governance personnel.

We will also look at the reasons why people chose not to take part in PROPS, and where the recruitment process might be improved.

This study will provide information that will help current and future clinical trials based in primary care overcome the problems encountered by PROPS.