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Published in: Trials 1/2006

Open Access 01-12-2006 | Research

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

Authors: Claire Snowdon, Diana R Elbourne, Jo Garcia, Marion K Campbell, Vikki A Entwistle, David Francis, Adrian M Grant, Rosemary C Knight, Alison M McDonald, Ian Roberts

Published in: Trials | Issue 1/2006

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Abstract

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).

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.

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.

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.
Literature
1.
2.
3.
Chalmers I, Rounding C, Lock K: Descriptive survey of non-commercial randomised controlled trials in the United Kingdom, 1980–2002. BMJ. 2003, 327: 1017-0. 10.1136/bmj.327.7422.1017.CrossRefPubMedPubMedCentral
4.
5.
Bodenheimer T: Uneasy alliance: clinical investigators and the pharmaceutical industry. N Engl J Med. 2000, 342: 1539-1544. 10.1056/NEJM200005183422024.CrossRefPubMed
6.
7.
8.
Mitchell CD: Harmful impact of EU clinical trials directive: ...while paediatric oncology is being scuppered. BMJ. 2006, 332: 666-10.1136/bmj.332.7542.666-b.CrossRefPubMedPubMedCentral
9.
Hanning CD, Rentowl P: Harmful impact of EU clinical trials directive: Trial of alerting drug in fibromyalgia has had to be abandoned. BMJ. 2006, 332: 666-10.1136/bmj.332.7542.666.CrossRefPubMedPubMedCentral
10.
Watson M: Harmful impact of EU clinical trials directive: ...and so has trial of melatonin in cancer related weight loss... BMJ. 2006, 332: 666-10.1136/bmj.332.7542.666-a.CrossRefPubMedPubMedCentral
11.
Emanuel EJ, Schnipper LE, Kamin DY, Levinson J, Lichter AS: The costs of conducting clinical research. J Clin Oncol. 2003, 21 (22): 4145-50. 10.1200/JCO.2003.08.156.CrossRefPubMed
12.
Aaronson NK, Visser-Pol E, Leenhouts GH, Muller MJ, van der Schot AC, van Dam FS, Keus RB, 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. J Clin Oncol. 1996, 14 (3): 984-996.PubMed
13.
Dickinson CJ: Clinical research in the NHS today. J R Coll Physicians Lond. 1994, 28 (5): 460-463.PubMed
14.
Smyth JF, Mossman J, Hall R, Hepburn S, Pinkerton R, Richards M, Thatcher N, Box J: Conducting clinical research in the new NHS: the model of cancer. United Kingdom Coordinating Committee on Cancer Research. BMJ. 1994, 309: 457-461.CrossRefPubMedPubMedCentral
15.
Shea S, Bigger JT, Campion J, Fleiss JL, Rolnitzky LM, Schron E, Gorkin L, Handshaw K, Kinney MR, Branyon M: Enrollment in clinical trials: institutional factors affecting enrollment in the cardiac arrhythmia suppression trial (CAST). Control Clin Trials. 1992, 13 (6): 466-86. 10.1016/0197-2456(92)90204-D.CrossRefPubMed
16.
Morse EV, Simon PM, Besch CL, Walker J: Issues of recruitment, retention, and compliance in community-based clinical trials with traditionally underserved populations. Appl Nurs Res. 1995, 8 (1): 8-14. 10.1016/S0897-1897(95)80240-1.CrossRefPubMed
17.
Foley JF, Moertel CG: Improving accrual into cancer clinical trials. J Cancer Educ. 1991, 6 (3): 165-73.CrossRefPubMed
18.
Ross S, Grant A, Counsell C, Gillespie W, Russell I, Prescott R: Barriers to participation in randomised controlled trials: a systematic review. J Clin Epidemiol. 1999, 52 (12): 1143-1156. 10.1016/S0895-4356(99)00141-9.CrossRefPubMed
19.
Campbell M, Snowdon C, Francis D, Elbourne D, McDonald A, Knight R, Entwistle V, Garcia J, Roberts I, Grant A, (The STEPS Group): Recruitment to randomised trials: Strategies for Trial Enrolment and Participation Study (STEPS). HTA Methodology Programme Monograph.
20.
21.
Snowdon C, Elbourne D, Garcia J, the STEPS Study Group: Strategies for Trials Enrolment and Participation Study: Case Studies [abstract]. Clinical Trials. 2005, 253-Suppl 2
22.
Francis D, Roberts I, Elbourne D, Campbell MK, the STEPS study group: Clinical trials as businesses: strategies for trials enrolment and participation study [abstract]. Clin Trials. 2005, 579-580. Suppl 2
23.
Baines CJ: Impediments to recruitment in the Canadian National Breast Screening Study: response and resolution. Control Clin Trials. 1984, 5 (2): 129-40. 10.1016/0197-2456(84)90119-3.CrossRefPubMed
24.
Taylor KM, Margolese RG, Soskolne CL: Physicians' reasons for not entering eligible patients in a randomized clinical trial of surgery for breast cancer. N Engl J Med. 1984, 310 (21): 1363-7.CrossRefPubMed
25.
Klein MC, Kaczorowski J, Robbins JM, Gauthier RJ, Jorgensen SH, Joshi AK: Physician's beliefs and behaviour during a randomized controlled trial of episiotomy: consequences for women in their care. Can Med Assoc J. 1995, 153 (6): 69-79.
26.
Fairhurst K, Dowrick C: Problems with recruitment in a randomized controlled trial of counselling in general practice: causes and implications. J Health Serv Res Policy. 1996, 1 (2): 77-80.PubMed
27.
Leach MJ: Barriers to conducting randomised controlled trials: lessons learnt from the Horsechestnut & Venous Leg Ulcer Trial (HAVLUT). Contemp Nurse. 2003, 15 (1–2): 37-47.CrossRefPubMed
28.
Heart Protection 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. 2004, 363: 757-67. 10.1016/S0140-6736(04)15690-0.CrossRef
29.
Heart Protection Study Collaborative Group: MRC/BHF Heart Protection Study of cholesterol-lowering with simvastatin in 5963 individuals with diabetes: a randomised placebo-controlled trial. Lancet. 2003, 361: 2005-20016. 10.1016/S0140-6736(03)13636-7.CrossRef
30.
Seymour M: Fluorouracil, Oxaliplatin and CPT-11 (irinotecan), use and sequencing (MRC FOCUS): a 2135- patient randomized trial in advanced colorectal cancer (ACRC)[abstract]. Journal of Clinical Oncology. 2005, 23: 3518-
31.
32.
Gowers SG, Clark A, Roberts C, Shore A, Edwards V, Bryan , Smethurst N, Byford S, Barratt B, Harrington RC: Two year outcomes of a randomised controlled trial for adolescent anorexia nervosa (the TOuCAN trial).
33.
May CR, Williams TL, Mair FS, Mort MM, Shaw NT, Gask L: Factors influencing the evaluation of telehealth interventions: preliminary results from a qualitative study of evaluation projects in the UK. J Telemed Telecare. 2002, 8 (Suppl 2): 65-7. 10.1258/135763302320302073.CrossRefPubMed
34.
May C, Mort M, Williams T, Mair F, Gask L: Health technology assessment in its local contexts: studies of telehealthcare. Soc Sci Med. 2003, 57 (4): 697-710. 10.1016/S0277-9536(02)00419-7.CrossRefPubMed
35.
Hamilton Brown A: Integrating research and practice in the CSAT Methamphetamine Treatment Project. J Subst Abuse Treat. 2004, 26 (2): 103-108. 10.1016/S0740-5472(03)00163-6.CrossRefPubMed
36.
Benson AB, Pregler JP, Bean JA, Rademaker AW, Eshler B, Anderson K: Oncologists' reluctance to accrue patients onto clinical trials: an Illinois Cancer Centre study. J Clin Oncol. 1991, 9 (11): 2067-2075.PubMed
37.
Taylor KM, Feldstein ML, Skeel RT, Pandya KJ, Ng P, Carbone PP: Fundamental dilemmas of the randomized clinical trial process: results of a survey of the 1737 Eastern Cooperative Oncology Group investigators. J Clin Oncol. 1994, 12: 1796-805.PubMed
38.
Langley C, Gray S, Selley S, Bowie C, Price C: Clinicians' attitudes to recruitment to randomised trials in cancer care: a qualitative study. J Health Serv Res Policy. 2000, 5 (3): 164-9.PubMed
39.
Grunfeld E, Zitzelsberger L, Coristine M, Aspelund F: Barriers and facilitators to enrollment in cancer clinical trials: qualitative study of the perspectives of clinical research associates. Cancer. 2002, 95 (7): 1577-1583. 10.1002/cncr.10862.CrossRefPubMed
40.
Fallowfield L, Ratcliffe D, Souhami R: Clinicians' attitudes to clinical trials of cancer therapy. Eur J Cancer. 1997, 33 (13): 2221-2229. 10.1016/S0959-8049(97)00253-0.CrossRefPubMed
41.
Siminoff LA, Zhang A, Colabianchi N, Sturm CM, Shen Q: Factors that predict the referral of breast cancer patients onto clinical trials by their surgeons and medical oncologists. J Clin Oncol. 2000, 18 (6): 1203-1211.PubMed
42.
Kornblith AB, Kemeny M, Peterson BL, Wheeler J, Crawford J, Bartlett N, Fleming G, Graziano S, Muss H, Cohen HJ, Cancer and Leukemia Group B: Survey of oncologists' perceptions of barriers to accrual of older patients with breast carcinoma to clinical trials. Cancer. 2002, 95 (5): 989-996. 10.1002/cncr.10792.CrossRefPubMed
43.
Joffe S, Weeks JC: Views of American oncologists about the purposes of clinical trials. J Natl Cancer Inst. 2002, 94 (24): 1847-1853.CrossRefPubMed
44.
Ross C, Cornbleet M: Attitudes of patients and staff to research in a specialist palliative care unit. Palliat Med. 2003, 17 (6): 491-497. 10.1191/0269216303pm785oa.CrossRefPubMed
45.
Peto V, Coulter A, Bond A: Factors affecting general practitioners' recruitment of patients into a prospective study. Fam Pract. 1993, 10 (2): 207-211. 10.1093/fampra/10.2.207.CrossRefPubMed
46.
Ellis PM, Hobbs MK, Rikard-Bell GC, Ward JE: General practitioners' attitudes to randomised clinical trials for women with breast cancer. Med J Aust. 1999, 171 (6): 303-305.PubMed
47.
Pearl A, Wright S, Gamble G, Doughty R, Sharpe N: Randomised trials in general practice-a New Zealand experience in recruitment. N Z Med J. 2003, 116 (1186): U681-PubMed
48.
Prout H, Butler C, Kinnersley P, Robling M, Hood K, Tudor-Jones R: A qualitative evaluation of implementing a randomized controlled trial in general practice. Fam Pract. 2003, 20 (6): 675-681. 10.1093/fampra/cmg609.CrossRefPubMed
49.
de Vaus DA: Surveys in Social Research. 1991, London: University College London Press
50.
Wilson K, Roe B, Wright L: Telephone or face-to-face interviews? A decision made on the basis of a pilot study. International Journal of Nursing Studies. 1998, 35 (6): 314-321. 10.1016/S0020-7489(98)00044-3.CrossRefPubMed
51.
Smith E: Telephone interviews in healthcare research: a summary of the evidence. Nurse Researcher. 2005, 12 (3): 32-41.CrossRefPubMed
52.
Breen A, Austin H, Campion-Smith C, Carr E, Mann E: "You feel so hopeless": A qualitative study of GP management of acute back pain. Eur J Pain. 2007, 11 (1): 21-29. 10.1016/j.ejpain.2005.12.006.CrossRefPubMed
53.
Rose PW, Ziebland S, Harnden A, Mayon-White R, Mant D, Oxford 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. 2006, 23 (2): 226-232. 10.1093/fampra/cmi101.CrossRef
54.
Worth A, Boyd K, Kendall M, Heaney D, Macleod U, Cormie P, Hockley J, Murray S: Out-of-hours palliative care: a qualitative study of cancer patients, carers and professionals. Br J Gen Pract. 2006, 56 (522): 6-13.PubMedPubMedCentral
55.
Waterman H, Leatherbarrow B, Slater R, Waterman C: Post-operative pain, nausea and vomiting: qualitative perspectives from telephone interviews. J Adv Nurs. 1999, 29 (3): 690-696. 10.1046/j.1365-2648.1999.00938.x.CrossRefPubMed
56.
McCormick KM, McClement S, Naimark BJ: A qualitative analysis of the experience of uncertainty while awaiting coronary artery bypass surgery. Can J Cardiovasc Nurs. 2005, 15 (1): 10-22.PubMed
57.
Ziebland S, Graham A, McPherson A: Concerns and cautions about prescribing and deregulating emergency contraception: a qualitative study of GPs using telephone interviews. Fam Pract. 1998, 15 (5): 449-456. 10.1093/fampra/15.5.449.CrossRefPubMed
58.
Murchie P, Campbell NC, Ritchie LD, Thain J: Running nurse-led secondary prevention clinics for coronary heart disease in primary care: qualitative study of health professionals' perspectives. Br J Gen Pract. 2005, 55 (516): 522-528.PubMedPubMedCentral
59.
Sweet L: Telephone interviewing: is it compatible with interpretive phenomenological research?. Contemp Nurse. 2002, 12 (1): 58-63.CrossRefPubMed
60.
Layder D: Sociological Practice: linking theory and social research. 1998, London: SageCrossRef
61.
Gowers SG: Evidence Based Research in CBT with Adolescent Eating Disorders. Child and Adolescent Mental Health. 2006, 11 (1): 9-12. 10.1111/j.1475-3588.2005.00348.x.CrossRef
62.
National Institute for Clinical Excellence: Guidance on the use of irinotecan, oxaliplatin and raltitrexed for the treatment of advanced colorectal cancer. 2002, London: NICE, (Technology Appraisal No. 33)
63.
64.
65.
Weatherall D: Problems for biomedical research at the academia-industrial interface. Sci Eng Ethics. 2003, 9 (1): 43-48.CrossRefPubMed
66.
Lewis S, Baird P, Evans RG, Ghali WA, Wright CJ, Gibson E, Baylis F: Dancing with the porcupine: rules for governing the university – industry relationship. CMAJ. 2001, 165 (6): 783-785.PubMedPubMedCentral
67.
Weatherall D: Academia and industry: increasingly uneasy bedfellows. Lancet. 2000, 355 (9215): 1574-10.1016/S0140-6736(00)02211-X.CrossRefPubMed
68.
Montaner JS, O'Shaughnessy MV, Schechter MT: Industry-sponsored clinical research: a double-edged sword. Lancet. 2001, 358 (9296): 1893-1895. 10.1016/S0140-6736(01)06891-X.CrossRefPubMed
69.
Moses H, Martin JB: Academic relationships with industry: a new model for biomedical research. JAMA. 2001, 285: 933-935. 10.1001/jama.285.7.933.CrossRefPubMed
70.
Chopra SS: Industry funding of clinical trials: benefit or bias?. JAMA. 2003, 290 (1): 113-114. 10.1001/jama.290.1.113.CrossRefPubMed
71.
Djulbegovic B, Lacevic M, Cantor A, Fields KK, Bennett CL, Adams JR, Kuderer NM, Lyman GH: The uncertainty principle and industry-sponsored research. Lancet. 2000, 356 (9230): 635-638. 10.1016/S0140-6736(00)02605-2.CrossRefPubMed
72.
Fries JF, Krishnan E: Equipoise, design bias, and randomised controlled trials: the elusive ethics of new drug development. Arthritis Res Ther. 2004, 6 (3): R250-255. 10.1186/ar1170.CrossRefPubMedPubMedCentral
73.
Lexchin J, Bero LA, Djulbegovic B, Clark O: Pharmaceutical industry sponsorship and research outcome and quality: systematic review. BMJ. 2003, 326 (7400): 1167-1170. 10.1136/bmj.326.7400.1167.CrossRefPubMedPubMedCentral
74.
Bekelman JE, Li Y, Gross CP: Scope and impact of financial conflicts of interest in biomedical research: a systematic review. JAMA. 2003, 289 (4): 454-465. 10.1001/jama.289.4.454.CrossRefPubMed
75.
Patsopoulos NA, Ioannidis JP, Analatos AA: Origin and funding of the most frequently cited papers in medicine: database analysis. BMJ. 2006, 332 (7549): 1061-1064. 10.1136/bmj.38768.420139.80.CrossRefPubMedPubMedCentral
76.
Black HR, Elliott WJ, Grandits G, Grambsch P, Lucente T, White WB, Neaton JD, Grimm RH, Hansson L: Principal results of the Controlled Onset Verapamil Investigation of Cardiovascular End Points (CONVINCE) trial. JAMA. 2003, 289: 2073-2082. 10.1001/jama.289.16.2073.CrossRefPubMed
77.
Drueke TB, Descamps-Latscha B, Locatelli F: Stopping a medical research project for financial reasons. Nephrol Dial Transplant. 2003, 18 (10): 1982-1983. 10.1093/ndt/gfg469.CrossRefPubMed
78.
Psaty BM, Rennie D: Stopping medical research to save money. J Am Med Assoc. 2003, 289: 2128-2131. 10.1001/jama.289.16.2128.
79.
Lexchin JR: Implications of pharmaceutical industry funding on clinical research. Ann Pharmacother. 2005, 39 (1): 194-197.CrossRefPubMed
80.
81.
Gates S, Brocklehurst P, Campbell MK, Elbourne DR: Recruitment to multicentre trials. BJOG. 2004, 111: 3-5. 10.1111/j.1471-0528.2004.00011.x.CrossRefPubMed
82.
Metadata
Title
Financial considerations in the conduct of multi-centre randomised controlled trials: evidence from a qualitative study
Authors
Claire Snowdon
Diana R Elbourne
Jo Garcia
Marion K Campbell
Vikki A Entwistle
David Francis
Adrian M Grant
Rosemary C Knight
Alison M McDonald
Ian Roberts
Publication date
01-12-2006
Publisher
BioMed Central
Published in
Trials / Issue 1/2006
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/1745-6215-7-34

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