What influences participation in clinical trials in palliative care in a cancer centre?

https://doi.org/10.1016/S0959-8049(99)00330-5Get rights and content

Abstract

Like any other speciality, palliative care needs a scientific foundation on which to base its practice. Research in palliative care is particularly difficult because of the characteristics of the patient population under study (e.g. advanced disease, poor performance status and limited prognosis). The aim of this paper was to highlight the challenges of recruitment into clinical trials in palliative care. Information on all patients treated at a specialist cancer centre who were referred for consideration of entry into any one of 23 clinical trials in palliative care was collected prospectively over 4 years to determine factors that influence patients to accept or reject entry into a study. Of the 1206 patients referred, 558 (46%) met the entry criteria. Of these, 362 (30%) agreed to enter and 248 (21% of all those referred) completed the study. Thus, 65% of all eligible patients were entered into trials but only 44% of these completed the study. The relatively high percentage of patients entered probably reflects the site (a cancer centre with a high research profile) and is not typical of other palliative care centres or hospices. The most common reasons given for unwillingness to participate were a wish to defer to a later date, a deterioration in condition, distance from home to hospital, a lack of interest, transfer to another unit, inability to give consent and family objection. In order to maximise patient accrual into trials in palliative care, studies should be designed to suit the patient population under study (e.g. be of short duration with realistic entry criteria) and not necessarily mirror the trial methodology of therapeutic trials in oncology.

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.

References (20)

  • R Twycross

    Research and palliative carethe pursuit of reliable knowledge

    Palliat. Med.

    (1993)
  • J Corner

    A new forum for research, debate and advice

    Palliat. Med.

    (1996)
  • Twycross R, Dunn V. Research in palliative care: the pursuit of reliable knowledge. Occasional paper 5. London National...
  • G.C Rinck et al.

    Methodological issues in effectiveness research on palliative cancer carea systematic review

    J. Clin. Oncol.

    (1997)
  • G Rinck et al.

    Trials in palliative care

    Br. Med. J.

    (1995)
  • H McQuay et al.

    Need for rigorous assessment of palliative care

    Br. Med. J.

    (1994)
  • D Clark

    What is qualitative research and what can it contribute to palliative care?

    Palliat. Med.

    (1997)
  • B Sibbald et al.

    Why are randomised controlled trials important?

    Br. Med. J.

    (1998)
  • M Slevin et al.

    Volunteers or victimspatients' views of randomised cancer clinical trials

    Br. J. Cancer

    (1995)
  • J Hardy

    Placebo controlled trials in palliative carethe argument for

    Palliat. Med.

    (1997)
There are more references available in the full text version of this article.

Cited by (0)

View full text