Unique study explores patient experience of clinical trials
by Dr Annmarie Nelson Deputy Director of the Marie Curie Palliative Care Research Centre, Cardiff
We often hear from patients and families that they want to take part in research and that for many it can be a really positive experience. Yet, very little research has actually explored the experiences of patients taking part in studies, especially clinical trials of drugs. So we have just published a paper looking at exactly this. This is an important area to study: if we’re able to further improve the experience of participating in research for patients, it may help encourage more people to take part and ultimately improve care for future patients. Ours is the first study to explore patient experience as an outcome, or end result, in a clinical trial of a drug. We used the unusual method of embedding our research into a study that was already ongoing – in this case a trial assessing two drugs for breast cancer patients with bone metastases. People taking part in the trial were randomly allocated to receive one of two different drugs, one was given intravenously at a clinic, and one was taken orally at home. We interviewed people about their experiences and understanding of the treatment, the experience of being given a drug intravenously or orally, side effects and benefits, and quality of life issues. People were generally happy with the treatment that they had been randomly assigned to, although most would initially have preferred to have the oral drug. Some people said that they’d had difficulties because of needle phobia in the intravenous group, or difficulty with swallowing in the oral group. But pain control was improved in both. Most people involved understood the trial processes, for example the need for randomisation. But some showed little understanding of certain aspects of the trial. This highlights that it is important to make sure that researchers explain everything properly to people who are taking part in clinical trials – and provide them with information when they need it, and in a way that they want. Some people would like things written down to refer to later; some would prefer to have things explained face to face. It would be useful to check patients’ understanding as time goes on. The views and preferences of people taking part in clinical trials are useful and should be taken into account when prescribing in the real world. The study was funded by Velindre NHS Trust Charitable Funds Committee. Nelson A, Fenlon D, Morris J, Sampson C, Harrop E, Murray N, Wheatley D, Hood K, Griffiths G and Barrett-Lee P (2013) QUALZICE: A QUALitative exploration of the experiences of particiapnts from the ZICE clinical trial (metastatic breast cancer) receiving intravenous or oral bisphosphonates. BMC Trials 14: 325 doi:10.1186/1745-6215-14-325.