Sponsors' participation in conduct and reporting of industry trials: a descriptive study

Trials

Volumn 13, Issue , 2012, Pages

  Lundh, Andreas ^a,b   Krogsbøll, Lasse T ^a,b   Gøtzsche, Peter C ^a,b  

^a Rigshospitalet   (Denmark)

^b UNIVERSITY OF COPENHAGEN   (Denmark)

Author keywords

Academic authors; Industry sponsorship; Randomised trials; Trial protocols

Indexed keywords

ARTICLE; CLINICAL PROTOCOL; DATA ANALYSIS; DATA BASE; HEALTH CARE ORGANIZATION; INFORMATION PROCESSING; MEDICAL RESEARCH; PUBLICATION; RANDOMIZED CONTROLLED TRIAL (TOPIC); SYSTEMATIC REVIEW;

AUTHORSHIP; BIAS (EPIDEMIOLOGY); BIBLIOMETRICS; CONFLICT OF INTEREST; COOPERATIVE BEHAVIOR; DATA INTERPRETATION, STATISTICAL; DRUG INDUSTRY; ENDPOINT DETERMINATION; HUMANS; INTERDISCIPLINARY COMMUNICATION; INTERINSTITUTIONAL RELATIONS; PERIODICALS AS TOPIC; PUBLICATION BIAS; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RESEARCH DESIGN; RESEARCH SUPPORT AS TOPIC; SCIENTIFIC MISCONDUCT; TREATMENT OUTCOME; TRUTH DISCLOSURE; WRITING;

EID: 84865296360     PISSN: None     EISSN: 17456215     Source Type: Journal    
DOI: 10.1186/1745-6215-13-146     Document Type: Article

References (28)

1. Dorsey ER, de Roulet J, Thompson JP, Reminick JI, Thai A, White-Stellato Z, Beck CA, George BP, Moses H. Funding of US biomedical research, 2003-2008. JAMA 2010, 303:137-143. 10.1001/jama.2009.1987, 3118092, 20068207.
2. Lundh A, Barbateskovic M, Hróbjartsson A, Gøtzsche PC. Conflicts of interest at medical journals: the influence of industry-supported randomised trials on journal impact factors and revenue - cohort study. PLoS Med 2010, 7:e1000354. 10.1371/journal.pmed.1000354, 2964336, 21048986.
3. Lexchin J, Bero LA, Djulbegovic B, Clark O. Pharmaceutical industry sponsorship and research outcome and quality: systematic review. BMJ 2003, 326:1167-1170. 10.1136/bmj.326.7400.1167, 156458, 12775614.
4. Sismondo S. Pharmaceutical company funding and its consequences: a qualitative systematic review. Contemp Clin Trials 2008, 29:109-113. 10.1016/j.cct.2007.08.001, 17919992.
5. Bero LA, Rennie D. Influences on the quality of published drug studies. Int J Technol Assess Health Care 1996, 12:209-237. 10.1017/S0266462300009582, 8707496.
6. Dwan K, Altman DG, Arnaiz JA, Bloom J, Chan A-W, Cronin E, Decullier E, Easterbrook PJ, Von Elm E, Gamble C, Ghersi D, Ioannidis JP, Simes J, Williamson PR. Systematic review of the empirical evidence of study publication bias and outcome reporting bias. PLoS One 2008, 3:e3081. 10.1371/journal.pone.0003081, 2518111, 18769481.
7. DeAngelis CD, Fontanarosa PB. The importance of independent academic statistical analysis. Biostatistics 2010, 11:383-384. 10.1093/biostatistics/kxq027, 20538872.
8. Schulman KA, Seils DM, Timbie JW, Sugarman J, Dame LA, Weinfurt KP, Mark DB, Califf RM. A national survey of provisions in clinical-trial agreements between medical schools and industry sponsors. N Engl J Med 2002, 347:1335-1341. 10.1056/NEJMsa020349, 12397192.
9. Gøtzsche PC, Hróbjartsson A, Johansen HK, Haahr MT, Altman DG, Chan AW. Constraints on publication rights in industry-initiated clinical trials. JAMA 2006, 295:1645-1646. 10.1001/jama.295.14.1645, 16609085.
10. Lundh A, Krogsbøll LT, Gøtzsche PC. Access to data in industry-sponsored trials. Lancet 2011, 378:1995-1996.
11. Gøtzsche PC, Hróbjartsson A, Johansen HK, Haahr MT, Altman DG, Chan AW. Ghost authorship in industry-initiated randomised trials. PLoS Med 2007, 4:e19. 10.1371/journal.pmed.0040019, 1769411, 17227134.
12. Rose SL, Krzyzanowska MK, Joffe S. Relationships between authorship contributions and authors' industry financial ties among oncology clinical trials. J Clin Oncol 2010, 28:1316-1321. 10.1200/JCO.2008.21.6606, 3040064, 20065190.
13. Tuech JJ, Moutel G, Pessaux P, Thoma V, Schraub S, Herve C. Disclosure of competing financial interests and role of sponsors in phase III cancer trials. Eur J Cancer 2005, 41:2237-2240. 10.1016/j.ejca.2004.12.036, 16214044.
14. Healy D. Let them eat Prozac 2004, New York: New York University Press.
15. Furukawa TA. All clinical trials must be reported in detail and made publicly available. BMJ 2004, 329:626. 516671, 15361465.
16. Bombardier C, Laine L, Reicin A, Shapiro D, Burgos-Vargas R, Davis B, Day R, Ferraz MB, Hawkey CJ, Hochberg MC, Kvien TK, Schnitzer TJ, . VIGOR Study Group Comparison of upper gastrointestinal toxicity of rofecoxib and naproxen in patients with rheumatoid arthritis. N Engl J Med 2000, 343:1520-1528. 2 p following 1528, 10.1056/NEJM200011233432103, 11087881, VIGOR Study Group.
17. Curfman GD, Morrissey S, Drazen JM. Expression of concern: Bombardier et al., " Comparison of upper gastrointestinal toxicity of rofecoxib and naproxen in patients with rheumatoid arthritis," N Engl J Med 2000; 343: 1520-8. N Engl J Med 2005, 353:2813-2814. 10.1056/NEJMe058314, 16339408.
18. Psaty BM, Prentice RL. Minimizing bias in randomized trials: the importance of blinding. JAMA 2010, 304:793-794. 10.1001/jama.2010.1161, 20716744.
19. FDA Briefing Document. Advisory Committee Meeting for NDA 21071 Avandia (rosiglitazone maleate) tablet, July 13 and 14, 2010 [http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/EndocrinologicandMetabolicDrugsAdvisoryCommittee/UCM218493.pdf].
20. Psaty BM, Kronmal RA. Reporting mortality findings in trials of rofecoxib for Alzheimer disease or cognitive impairment: a case study based on documents from rofecoxib litigation. JAMA 2008, 299:1813-1817. 10.1001/jama.299.15.1813, 18413875.
21. Herper M. Money, math and medicine. Forbes Magazine 2010, [http://www.forbes.com/forbes/2010/1122/private-companies-10-quintiles-dennis-gillings-money-medicine.html].
22. Sismondo S. How pharmaceutical industry funding affects trial outcomes: causal structures and responses. Soc Sci Med 2008, 66:1909-1914. 10.1016/j.socscimed.2008.01.010, 18299169.
23. Gøtzsche PC. Why we need easy access to all data from all clinical trials and how to accomplish it. Trials 2011, 12:249. 10.1186/1745-6215-12-249, 3264537, 22112900.
24. McGauran N, Wieseler B, Kreis J, Schüler Y-B, Kölsch H, Kaiser T. Reporting bias in medical research - a narrative review. Trials 2010, 11:37. 10.1186/1745-6215-11-37, 2867979, 20388211.
25. Bassler D, Briel M, Montori VM, Lane M, Glasziou P, Zhou Q, Heels-Ansdell D, Walter SD, Guyatt GH, Flynn DN, Elamin MB, Murad MH, Abu Elnour NO, Lampropulos JF, Sood A, Mullan RJ, Erwin PJ, Bankhead CR, Perera R, Ruiz Culebro C, You JJ, Mulla SM, Kaur J, Nerenberg KA, Schünemann H, Cook DJ, Lutz K, Ribic CM, Vale N, , et al. STOPIT-2 Study Group Stopping randomized trials early for benefit and estimation of treatment effects: systematic review and meta-regression analysis. JAMA 2010, 303:1180-1187. 10.1001/jama.2010.310, 20332404, STOPIT-2 Study Group.
26. Trotta F, Apolone G, Garattini S, Tafuri G. Stopping a trial early in oncology: for patients or for industry?. Ann Oncol 2008, 19:1347-1353. 10.1093/annonc/mdn042, 18304961.
27. Wager E, Mhaskar R, Warburton S, Djulbegovic B. JAMA published fewer industry-funded studies after introducing a requirement for independent statistical analysis. PLoS One 2010, 5:e13591. 10.1371/journal.pone.0013591, 2962640, 21042585.
28. Strengthening the credibility of clinical research. Lancet 2010, 375:1225. 10.1016/S0140-6736(10)60523-5, 20382309.