What influences participation in clinical trials in palliative care in a cancer centre?
Introduction
The need for research in palliative care has been well documented 1, 2, 3, but most practitioners within the speciality would acknowledge that research in this field is particularly difficult 4, 5, 6. Recruitment to trials and research projects is often slow and further complicated by high attrition rates. The patient population is very unwell and nearing the end of life. Consequently, the problems experienced are complex physical, emotional and ethical ones. In an attempt to overcome some of the difficult recruitment problems, various research methodologies have been utilised with qualitative research becoming a popular option [7]. The pharmacological treatment of symptoms, however, still requires the use of quantitative research methodology often in the context of randomised controlled clinical trials (RCTs) [8].
Poor recruitment to clinical trials is not a problem that is exclusive to palliative care. Similar problems in recruitment to clinical trials in oncology have been reported [9]. Recognition of the difficulties in undertaking research in palliative care does not exclude the speciality from the ‘rigours of scientific research’. On the contrary, palliative care needs a more scientific foundation upon which to base its practice [6]. Many of the ‘treatments’ which are widely used in this area are of unproven benefit [10]. Changes in healthcare funding have lead to a greater need to prove that the interventions employed in everyday practice, are not only efficacious and cost effective, but are based on scientific evidence [11]. Palliative care is not exempt from these conditions. Research has an important role in forming the foundations of what is a relatively new speciality.
In order to look for ways to improve recruitment of patients to palliative care clinical trials, it is just as important to understand why patients choose not to enter trials, as it is to understand why they do participate. This paper describes the experience encountered in recruiting patients to clinical trials within the Department of Palliative Medicine at the Royal Marsden NHS Trust, London and Surrey.
Section snippets
Patients and methods
The Royal Marsden NHS Trust is a specialist cancer centre situated on two sites. Each site has its own palliative care ward plus a hospital-wide support team. The Department of Palliative Medicine has an active interest in research. Regular research meetings are held to discuss proposed projects and to update current studies. Research projects undertaken include both pharmaceutical sponsored studies, and ‘in-house’ projects conceived and developed by both nursing and medical staff on the unit.
Results
In the period January 1993 to December 1996, 1206 patients were referred as ‘suitable’ for entry into one of the palliative care unit clinical trials. A total of 23 trials were in progress during the study period. The patients referred, 778 (65%) female and 428 (35%) male, represented a wide range of malignancies (Table 2) and were aged between 18 and 95 years with a median age of 60 years (Table 2). The median survival from time of referral to death in the 1111 patients in whom survival data
Discussion
The problems and pitfalls of undertaking research in palliative care effectiveness have been illustrated in a paper by McWhinney and colleagues [12]. This led to a call for papers highlighting methodological difficulties in palliative care research [13]. It is hoped that this paper might aid further research in the area by documenting the issues encountered in attempting to undertake research in palliative care within a large cancer centre.
These recruitment figures, although taken from patients
Conclusions
Whilst fully supporting the multidisciplinary nature of palliative care, it remains true that for many patients, drug therapy remains of fundamental importance in maintaining symptom control and quality of life. Many new drugs and drug formulations are becoming available and many of the older established drugs are used on the basis of anecdote or physician preference without a strong evidence base. The optimal use of these medications will often warrant a clinical trial.
The results of this
Acknowledgments
The authors would like to acknowledge the help of: Kathy Penn, George Lillie, Dr Carol Davis, Dr Karen Broadley, Dr Alison Duncan, Dr Patrick Stone and Dr Louisa Kreeger for their contribution and recruitment to the palliative care unit research projects during the period under study.
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