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Research strategy | Guidelines

Getting involved in clinical trials - our experience!

The following article was recently submitted to the Involve Newsletter for publication. Involve is an NHS organisation which promotes public involvement in the NHS, public health and social research. We think it may be of interest to those already participating or considering participation in the PRISM Trial.

The drive for consumer involvement in clinical trials has increased over recent years but there is often little if any guidance about how to actually DO this. We didn’t set out with a specific plan about involving consumers in the PRISM trial, but by recognising the benefits of working together and through a naturally evolving relationship, we have developed a integrated approach to consumer involvement in clinical trials, and would very much like to share our experience with you!

Paget’s disease of bone (PDB) is a chronic bone disease that is often painful and can have very disabling long-term complications such as bone deformity, fracture and even deafness. 125 years after it was first described by Sir James Paget, there are still a lot of unanswered questions about the management of this condition and the PRISM trial is a UK based, non-commercial, multicentre, randomised controlled trial, studying its treatment.

Within the UK there is only one formal support group for sufferers of PDB; the National Association for the Relief of Paget’s Disease (NARPD). The NARPD was founded in 1973 and aims to offer support and information to Paget's disease sufferers, to sponsor research into the causes and treatment of the disease, and to raise awareness of the disease among the medical profession and the public. NARPD members include patients, carers, and health professionals.

From the outset, the PRISM trial management group and the NARPD have worked in partnership to aid the design, conduct and delivery of the PRISM trial. The NARPD has been involved with the PRISM trial from the conceptual stages and helped to ‘set the question’. Since then, the NARPD has become involved in almost every aspect of the development and execution of PRISM, and almost without being aware of it has ensured that the research is relevant, and is targeted to answer specific and important questions.

It’s impossible to describe every aspect of the NARPD-PRISM trial relationship in a short article. However, from the trial’s point of view the primary advantage has been the harnessing of a well-informed and interested population, who have developed a sense of ownership of the trial. Also, NARPD members have become familiar with trial methodology, and this had fed through to very high response rates for follow-up quality of life questionnaires – an important component of the trial. Another consequence of making trial information freely available to NARPD patient members is that the PRISM trial has received a sizeable number of requests from patients asking to take part. Furthermore this active partnership has led to unsolicited patient advocacy of the trial.

But this isn’t all one sided! There have been benefits to the NARPD and its membership as well! The trial has promoted awareness of the NARPD and Paget’s disease, to sufferers, the general public AND health professionals.

But the best things in life are never easy! – It has been exceedingly hard work for both parties, but we do wholeheartedly feel that this relationship has been very rewarding, on both professional and personal levels.

PRISM Trial News

1060 people with Paget’s disease are taking part in the trial. We would like to say a very big THANK YOU to all those taking part in PRISM. Without your commitment and continued support, this important research could not take place.

Last Opportunity to Take Part!

If you would like to take part in the PRISM Trial, now is your last
opportunity to do so. After the 31st March 2004 we shall no longer be
engaging more people to the trial.

Medway Maritime Hospital, Gillingham, Joins the PRISM Trial! We welcome Dr Paul Ryan and his team at Medway Maritime Hospital, to the PRISM Trial. Dr
Ryan hopes to include up to 20 people from the Gillingham area.

If you would like more information contact Annie (the PRISM Trial Co-ordinator)
on 01224 551126 or prism@hsru.abdn.ac.uk