Recommendations for the relationship between sponsors and investigators in the design and conduct of clinical stroke trials

Stroke

Volumn 34, Issue 4, 2003, Pages 1041-1045

  Donnan, Geoffrey A ^a,c   Davis, Stephen M ^a   Kaste, Markku ^b  

^a UNIVERSITY OF MELBOURNE   (Australia)

^b HELSINKI UNIVERSITY CENTRAL HOSPITAL   (Finland)

^c FLOREY INSTITUTE OF NEUROSCIENCE AND MENTAL HEALTH   (Australia)

Author keywords

Clinical trials; Drug industry; Health planning guidelines; Research support

Indexed keywords

CLINICAL PRACTICE; CLINICAL RESEARCH; HUMAN; MEDICAL SOCIETY; METHODOLOGY; PRIORITY JOURNAL; REVIEW; STROKE;

CEREBROVASCULAR ACCIDENT; CLINICAL TRIALS; DRUG INDUSTRY; HUMANS; RESEARCH DESIGN; RESEARCH PERSONNEL;

EID: 0037383658     PISSN: 00392499     EISSN: None     Source Type: Journal    
DOI: 10.1161/01.STR.0000063142.39828.67     Document Type: Review

References (20)

1. Davidoff F, DeAngelis CD, Drazen JM, Hoey J, Hojgaard L, Horton R, Kotzin S, Nicholls MG, Nylenna M, Overbeke AJ, Sox HC, Van Der Weyden MB, Wilkes MS. Sponsorship, authorship, and accountability. Lancet. 2001;358:854-856.
2. Rosenberg RN, Aminoff M, Boller F, Soerensen PS, Griggs RC, Hachinski V, Hallett M, Johnson RT, Kennard C, Lang AE, Lees AJ, Lisak R, Newsom-Davis J, Pedley TA, Selzer ME, Zochodne D. Reporting clinical trials: full access to all the data. Arch Neurol. 2002;59:27-28.
3. Saver J, Kidwell C, Starkman S. Thrombolysis in stroke: it works! [commentary on BMJ. 2002;324:723-729]. BMJ. 2002;324:727.
4. Korn D. Conflicts of interest in biomedical research. JAMA. 2000;284:2234-2237.
5. Choudhry NK, Stelfox HT, Detsky AS. Relationships between authors of clinical practice guidelines and the pharmaceutical industry. JAMA. 2002;287:612-617.
6. Warlow C. Who pays the guideline writers? [commentary on BMJ. 2002;324:723-729]. BMJ. 2002;324:726.
7. Montaner JS, O'Shaughnessy MV, Schechter MT. Industry-sponsored clinical research: a double-edged sword. Lancet. 2001;358:1893-1895.
8. Djulbegovic B, Lacevic M, Cantor A, Fields KK, Bennett CL, Adams JR, Kuderer NM, Lyman GH. The uncertainty principle and industrysponsored research. Lancet. 2000;356:635-638.
9. Davidson RA. Source of funding and outcome of clinical trials. J Gen Intern Med. 1986;1:155-158.
10. Dorman PJ, Counsell C, Sandercock P. Reports of randomized trials in acute stroke, 1955 to 1995: what proportions were commercially sponsored? Stroke. 1999;30:1995-1998.
11. Donnan GA. From clinical trials to clinical practice. In: Norris J, Hachinski V, eds. Prevention of Stroke. New York, NY: Oxford University Press; 2001:275-293.
12. Stroke Therapy Academic Industry Roundtable II. Recommendations for clinical trial evaluation of acute stroke therapies. Stroke. 2001;32:1598-1606.
13. Mathieu M. Parexel's Pharmaceutical R&D Statistical Sourcebook, 1998. Waltham, Mass: Parexel International Corporation; 1999.
14. Begg C, Cho M, Eastwood S, Horton R, Moher D, Olkin I, Pitkin R, Rennie D, Schulz KF, Simel D, Stroup DF. Improving the quality of reporting of randomized controlled trials: the CONSORT statement. JAMA. 1996;276:637-639.
15. Food and Drug Administration (US). Guidance for clinical trial sponsors on the establishment and operation of clinical trial data monitoring committees (draft). Available at: http://www.fda.gov/cber/guidelines.htm. Accessed November 15, 2001.
16. Medical Research Council (UK). Guidelines for good clinical practice in clinical trials. Available at: http://www.mrc.ac.uk/pdf-ctg.pdf. Accessed March 1998.
17. European Agency for the Evaluation of Medicinal Products, Committee for Proprietary Medicine Products. Points to consider on clinical investigation of medicinal products for the treatment of acute stroke. Available at: http://www.emea.eu.int/pdfs/human/ewp/056098en.pdf. Accessed September 20, 2001.
18. Mann H. Research ethics committees and public dissemination of clinical trial results. Lancet. 2002;360:406-408.
19. Egger M, Dickersin K, Smith G. Problems and limitations in conducting systematic reviews. In: Egger M, Smith G, Altman D, eds. Systematic Reviews in Health Care: Meta-analysis in Context. London, UK: BMJ Books; 2001:46-50.
20. National Health and Medical Research Council. Guide to the Development, Implementation, and Evaluation of Clinical Practice Guidelines. Canberra, Australia: National Health and Medical Research Council, Australia; 1999. Catalog No. 9810223.