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Financial considerations in the conduct of multi-centre randomised controlled trials: rvidence from a qualitative study

By Claire Snowdon, Diana R. Elbourne, Jo Garcia, Marion K. Campbell, Vikki A. Entwistle, David Francis, Adrian M. Grant, Rosemary C. Knight, Alison M. MacDonald and Ian Roberts


BACKGROUND - Securing and managing finances for multicentre randomised controlled trials is a highly complex activity which is rarely considered in the research literature. This paper describes the process of financial negotiation and the impact of financial considerations in four UK multicentre trials. These trials had met, or were on schedule to meet, recruitment targets agreed with their public-sector funders. The trials were considered within a larger study examining factors which might be associated with trial recruitment (STEPS).\ud METHODS - In-depth semi-structured telephone interviews were conducted in 2003–04 with 45 individuals with various responsibilities to one of the four trials. Interviewees were recruited through purposive and then snowball sampling. Interview transcripts were analysed with the assistance of the qualitative package Atlas-ti.\ud RESULTS - The data suggest that the UK system of dividing funds into research, treatment and NHS support costs brought the trial teams into complicated negotiations with multiple funders. The divisions were somewhat malleable and the funding system was used differently in each trial. The fact that all funders had the potential to influence and shape the trials considered here was an important issue as the perspectives of applicants and funders could diverge. The extent and range of industry involvement in non-industry-led trials was striking. Three broad periods of financial work (foundation, maintenance, and resourcing completion) were identified. From development to completion of a trial, the trialists had to be resourceful and flexible, adapting to changing internal and external circumstances. In each period, trialists and collaborators could face changing costs and challenges. Each trial extended the recruitment period; three required funding extensions from MRC or HTA.\ud CONCLUSION - This study highlights complex financial aspects of planning and conducting trials, especially where multiple funders are involved. Recognition of the importance of financial stability and of the need for appropriate training in this area should be paralleled by further similar research with a broader range of trials, aimed at understanding and facilitating the conduct of clinical research

Topics: N215 Change and Innovation, B000 Health Professions
Publisher: BioMed Central
Year: 2006
DOI identifier: 10.1186/1745-6215-7-34
OAI identifier: oai:eprints.brighton.ac.uk:5633

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  1. (The STEPS Group): Recruitment to randomised trials: Strategies for Trial Enrolment and Participation Study (STEPS). HTA Methodology Programme Monograph
  2. A pragmatic single-blind RCT and health economic evaluation of leukotriene receptor antagonists in primary care at steps two and three of the National Asthma Guidelines (ELEVATE)
  3. (2006). A Review of UK Health Research Funding. Sir David Cooksey
  4. (1993). A: Factors affecting general practitioners' recruitment of patients into a prospective study. Fam Pract
  5. (2004). A: Integrating research and practice in the CSAT Methamphetamine Treatment Project. J Subst Abuse Treat
  6. (2000). Academia and industry: increasingly uneasy bedfellows. Lancet
  7. (1995). AK: Physician's beliefs and behaviour during a randomized controlled trial of episiotomy: consequences for women in their care. Can Med Assoc J
  8. (2006). Analatos AA: Origin and funding of the most frequently cited papers in medicine: database analysis. BMJ
  9. (2002). Aspelund F: Barriers and facilitators to enrollment in cancer clinical trials: qualitative study of the perspectives of clinical research associates. Cancer
  10. (2003). Attitudes of patients and staff to research in a specialist palliative care unit. Palliat Med
  11. (2003). Barriers to conducting randomised controlled trials: lessons learnt from the Horsechestnut & Venous Leg Ulcer Trial (HAVLUT). Contemp Nurse
  12. (1999). Barriers to participation in randomised controlled trials: a systematic review.
  13. (2002). Cancer and Leukemia Group B: Survey of oncologists' perceptions of barriers to accrual of older patients with breast carcinoma to clinical trials. Cancer
  14. (2006). Childhood Infection Study group (OXCIS): Why do general practitioners prescribe antibiotics for acute infective conjunctivitis in children? Qualitative interviews with GPs and a questionnaire survey of parents and teachers. Fam Prac
  15. (1994). Clinical research in the NHS today.
  16. (1997). Clinicians' attitudes to clinical trials of cancer therapy.
  17. (2000). Clinicians' attitudes to recruitment to randomised trials in cancer care: a qualitative study. J Health Serv Res Policy
  18. (1998). Concerns and cautions about prescribing and deregulating emergency contraception: a qualitative study of GPs using telephone interviews. Fam Pract
  19. (1994). Conducting clinical research in the new NHS: the model of cancer. United Kingdom Coordinating Committee on Cancer Research. BMJ
  20. (2002). Consultant medical oncologist and 27 other cancer care specialists, Colon Cancer Concern: NICE decision will reduce life expectancy. The Telegraph [http://www.tele graph.co.uk/opinion/main.jhtml?xml=/opinion/2002/06/0dt0702.xml].
  21. (2003). CP: Scope and impact of financial conflicts of interest in biomedical research: a systematic review. JAMA
  22. (1991). DA: Surveys in Social Research London:
  23. (2001). Dancing with the porcupine: rules for governing the university – industry relationship. CMAJ
  24. (1980). Descriptive survey of non-commercial randomised controlled trials in the United Kingdom, doi
  25. (1996). Dowrick C: Problems with recruitment in a randomized controlled trial of counselling in general practice: causes and implications.
  26. (2004). Draft guidance on clinical trials recognises needs of non-commercial research. BMJ
  27. (2004). Elbourne DR: Recruitment to multicentre trials. BJOG
  28. (2006). Enrollment in clinical trials: institutional factors affecting enrollment in the cardiac Trials
  29. (2006). Evidence Based Research in CBT with Adolescent Eating Disorders. Child and Adolescent Mental Health
  30. (2003). F: Stopping a medical research project for financial reasons. Nephrol Dial Transplant
  31. (2002). Factors influencing the evaluation of telehealth interventions: preliminary results from a qualitative study of evaluation projects in the UK.
  32. (2000). Factors that predict the referral of breast cancer patients onto clinical trials by their surgeons and medical oncologists.
  33. (2002). for Clinical Excellence: Guidance on the use of irinotecan, oxaliplatin and raltitrexed for the treatment of advanced colorectal cancer
  34. (2003). Gask L: Health technology assessment in its local contexts: studies of telehealthcare. Soc Sci Med
  35. (1999). General practitioners' attitudes to randomised clinical trials for women with breast cancer.
  36. (2000). GH: The uncertainty principle and industry-sponsored research. Lancet
  37. (2003). Hansson L: Principal results of the Controlled Onset Verapamil Investigation of Cardiovascular End Points (CONVINCE) trial. JAMA
  38. (2006). Harmful impact of EU clinical trials directive: ...and so has trial of melatonin in cancer related weight loss... BMJ doi
  39. (2006). Harmful impact of EU clinical trials directive: ...while paediatric oncology is being scuppered. BMJ doi
  40. Health, Attributing revenue costs of externally-funded
  41. (1984). Impediments to recruitment in the Canadian National Breast Screening Study: response and resolution. Control Clin Trials
  42. (2005). Implications of pharmaceutical industry funding on clinical research. Ann Pharmacother
  43. (2003). Industry funding of clinical trials: benefit or bias? JAMA
  44. (2001). Industry-sponsored clinical research: a double-edged sword. Lancet
  45. (1995). Issues of recruitment, retention, and compliance in community-based clinical trials with traditionally underserved populations. Appl Nurs Res
  46. (2001). JB: Academic relationships with industry: a new model for biomedical research. JAMA
  47. (2006). Kellokumpu-Lehtinen PL: Harmful impact of EU clinical trials directive. BMJ doi
  48. (1996). Koning CC, ten Bokkel Huinink WW, van Dongen JA, Dubbelman R: Telephone-based nursing intervention improves the effectiveness of the informed consent process in cancer clinical trials. doi
  49. (2004). Krishnan E: Equipoise, design bias, and randomised controlled trials: the elusive ethics of new drug development. Arthritis Res Ther
  50. (2003). Lichter AS: The costs of conducting clinical research.
  51. (1991). Moertel CG: Improving accrual into cancer clinical trials.
  52. Morals and money: dancing with porcupines or sleeping besides elephants.
  53. (2003). N: Randomised trials in general practice-a New Zealand experience in recruitment.
  54. (2005). Naimark BJ: A qualitative analysis of the experience of uncertainty while awaiting coronary artery bypass surgery.
  55. (1991). Oncologists' reluctance to accrue patients onto clinical trials: an Illinois Cancer Centre study.
  56. (2005). Oxaliplatin and CPT-11 (irinotecan), use and sequencing (MRC FOCUS): a 2135- patient randomized trial in advanced colorectal cancer (ACRC)[abstract].
  57. (2003). Pharmaceutical industry sponsorship and research outcome and quality: systematic review. BMJ
  58. (1999). Post-operative pain, nausea and vomiting: qualitative perspectives from telephone interviews.
  59. (1994). PP: Fundamental dilemmas of the randomized clinical trial process: results of a survey of the 1737 Eastern Cooperative Oncology Group investigators.
  60. (2003). Problems for biomedical research at the academia-industrial interface. Sci Eng Ethics
  61. RC: Two year outcomes of a randomised controlled trial for adolescent anorexia nervosa (the TOuCAN trial).
  62. (2003). Rennie D: Stopping medical research to save money.
  63. (2006). Rentowl P: Harmful impact of EU clinical trials directive: Trial of alerting drug in fibromyalgia has had to be abandoned. BMJ doi
  64. (2003). Resuscitating clinical research in the United Kingdom. BMJ
  65. (2005). Running nurse-led secondary prevention clinics for coronary heart disease in primary care: qualitative study of health professionals' perspectives.
  66. (2006). S: Out-of-hours palliative care: a qualitative study of cancer patients, carers and professionals.
  67. (2006). Snowdon C: What influences recruitment to randomised controlled trials? A review of trials funded by two UK funding agencies. Trials
  68. (1998). Sociological Practice: linking theory and social research London: Sage;
  69. (1984). Soskolne CL: Physicians' reasons for not entering eligible patients in a randomized clinical trial of surgery for breast cancer.
  70. (2004). Study Collaborative Group: Effects of cholesterol lowering with simvastatin on stroke and other major vascular events in 20 536 people with cerebrovascular disease or other high-risk conditions. Lancet
  71. (2003). Study Collaborative Group: MRC/BHF Heart Protection Study of cholesterol-lowering with simvastatin in 5963 individuals with diabetes: a randomised placebo-controlled trial. Lancet
  72. (2002). Telephone interviewing: is it compatible with interpretive phenomenological research? Contemp Nurse
  73. (2005). Telephone interviews in healthcare research: a summary of the evidence. Nurse Researcher
  74. (1998). Telephone or face-to-face interviews? A decision made on the basis of a pilot study.
  75. the STEPS study group: Clinical trials as businesses: strategies for trials enrolment and participation study [abstract].
  76. (2005). the STEPS Study Group: Strategies for Trials Enrolment and Participation Study: Case Studies [abstract]. Clinical Trials
  77. (2003). Tudor-Jones R: A qualitative evaluation of implementing a randomized controlled trial in general practice. Fam Pract
  78. (2000). Uneasy alliance: clinical investigators and the pharmaceutical industry. doi
  79. (2002). Weeks JC: Views of American oncologists about the purposes of clinical trials.
  80. (2007). You feel so hopeless": A qualitative study of GP management of acute back pain.

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