CLARIFY
CAD is the term that describes what happens when the heart’s blood supply is blocked or interrupted by a build-up of fatty substances in the coronary arteries: the network of blood vessels on the surface of the heart. Without treatment CAD can lead to heart failure. Progress in treatment of the CAD means that the condition is increasingly being managed in a primary care, as opposed to a secondary care setting. Understanding the management and outcomes of these patients is vital for reducing the CAD disease burden on health services, yet there is currently little data available on the effectiveness of treatment strategies.
The CLARIFY study aims to change this by gathering contemporary data from over 30,000 CAD patients over the next five years in 40 countries worldwide. Daniel Stevens is Servier’s National Cardiology Medical Liaison Manager and is responsible for coordinating the CLARIFY study in the UK. He describes the challenge this study presented, “CLARIFY is a simple study but on a massive scale and with a relatively small recruitment window. The study launched in August 2009 and the planned closure date was April 2010. By the autumn it was clear that it wasn’t all going to be plain sailing. I hadn’t come across the Network at that time but had started to get feedback that some GPs only wanted to work with us if we were in partnership with Primary Care Research Network, mainly because of the quality assurances and the support that the Network provided. So we submitted the study for adoption onto the PCRN Portfolio to see if it was eligible for Network support.
But because the timelines were tight we had to begin engaging practices prior to adoption. We couldn’t risk waiting for Portfolio approval.” CLARIFY was formally adopted by PCRN on 5 January 2010 and the Network set to work to get recruitment on track. The first measure was to expedite the permissions process so recruitment at new sites could get underway. A system developed during the swine flu pandemic was employed. Six of the eight Primary Care Local Research Networks (LRNs) supported the study. It was a fantastic turn-around. In the WCLRN, we rapidly made the site target of engaging local GPs from the BARONET group – they were exemplar in terms of recruitment, retention and punctuality of follow up.
The recruitment deadline was extended due to issues in other countries. The Network continued recruiting so when recruitment closed on 30 June the UK had exceeded its target of 2000 patients by 228, placing it third globally out of 40 countries. In England alone 1814 patients were recruited by 195 practices.
