Case study: Study Support Service - Effective Study Set-Up
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Study profile and summary
Lead Local Clinical Research Network: South London
Study name: PIVOTAL
Type: NIHR non-commercial Partner
Funder: Kidney Research UK
Recruitment target: 2080
Recruitment achieved: 2137
For a variety of reasons, dialysis patients often end up deficient in iron, and this has a number of important consequences including exacerbating anaemia, and reducing quality-of-life.
Intravenous (IV) iron injections have therefore been routinely administered to patients on dialysis for more than 20 years. However, despite its success, the optimal amount of IV iron that should be given is not known, and renal units across the UK vary widely in how much they give their patients. In 2013, the PIVOTAL study set about establishing what the optimum IV iron dosage is.
PIVOTAL was developed as an innovative collaboration between Kidney Research UK, the UK Renal Association Anaemia Clinical Study Group, life-sciences industry and the NIHR. PIVOTAL is an important study for the UK renal community. It is the largest clinical trial that has ever been conducted exclusively in UK renal units, and it is highly likely that the results will impact on clinical practice for dialysis worldwide.
“Due to the Network’s geographical spread, it helped us set up sites across England."
The Clinical Research Network has been a key component in the delivery of PIVOTAL. Trial Manager, Claire White, explains why:
“Due to the Network’s geographical spread, it helped us set up sites across England. Once the hub site was on board, the research nurses did a substantial amount of groundwork travelling to units, meeting staff and explaining the demands of the study”
“Collaborating with the Network also puts us at the heart of the renal community. The Network’s Renal Disorders Specialty Leads meet twice a year, which proved useful during set-up.
“The speciality leads were able to suggest potential investigators and sites across the UK who we could approach. It meant we were able to promote the study to the right people and maintain the momentum of site sign-ups.”
Chief Investigator Professor Iain Macdougall of King’s College Hospital, is delighted with PIVOTAL’s progress and excited at its potential national and international significance:
“Clearly, the results of the trial will have widespread impact, and will likely influence iron management in dialysis patients around the world. I would personally like to thank all the principal investigators, research nurses and study teams throughout the UK for the commitment and hard work they have put into the trial thus far.
“This study has not only shown that the UK can potentially conduct large randomised controlled trials in patients with chronic kidney disease, but has allowed a network of research nurses to collaborate, share experiences and learn from each other.”