Financial conflicts of interest and their association with outcome and quality of fibromyalgia drug therapy randomized controlled trials

International Journal of Rheumatic Diseases

Volumn 18, Issue 6, 2015, Pages 606-615

  Pang, Winnie K ^a   Yeter, Karen C ^a   Torralba, Karina D ^b   Spencer, Horace J ^c   Khan, Nasim A ^c  

^a UNIVERSITY OF SOUTHERN CALIFORNIA   (United States)

^b LOMA LINDA UNIVERSITY   (United States)

^c UNIVERSITY OF ARKANSAS FOR MEDICAL SCIENCES   (United States)

Author keywords

Clinical trials; Evidence based medicine; Fibromyalgia; Pain

Indexed keywords

4 AMINOBUTYRIC ACID DERIVATIVE; ANALGESIC AGENT; SEROTONIN AGONIST; SEROTONIN NORADRENALIN REUPTAKE INHIBITOR; SEROTONIN UPTAKE INHIBITOR; TRICYCLIC ANTIDEPRESSANT AGENT;

ARTICLE; CONFLICT OF INTEREST; CONSULTATION; CONTROLLED STUDY; CROSS-SECTIONAL STUDY; FIBROMYALGIA; FINANCIAL MANAGEMENT; FUNDING; HUMAN; INTENTION TO TREAT ANALYSIS; INTERNAL VALIDITY; MAJOR CLINICAL STUDY; NON PROFIT ORGANIZATION; OUTCOME ASSESSMENT; PARALLEL DESIGN; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SAMPLE SIZE; TREATMENT OUTCOME; DRUG COST; DRUG INDUSTRY; ECONOMICS; ETHICS; RANDOMIZED CONTROLLED TRIAL (TOPIC);

ANALGESICS; CONFLICT OF INTEREST; DRUG COSTS; DRUG INDUSTRY; FIBROMYALGIA; HUMANS; ORGANIZATIONS, NONPROFIT; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RESEARCH SUPPORT AS TOPIC; TREATMENT OUTCOME;

EID: 84940449808     PISSN: 17561841     EISSN: 1756185X     Source Type: Journal    
DOI: 10.1111/1756-185X.12607     Document Type: Article

References (43)

1. Carville SF, Arendt-Nielsen S, Bliddal H et al. (2008) EULAR evidence-based recommendations for the management of fibromyalgia syndrome. Ann Rheum Dis 67, 536-41.
2. Weir PT, Harlan GA, Nkoy FL et al. (2006) The incidence of fibromyalgia and its associated comorbidities: a population-based retrospective cohort study based on International Classification of Diseases, 9th Revision codes. J Clin Rheumatol 12, 124-8.
3. Bennett RM (2009) Clinical manifestations and diagnosis of fibromyalgia. Rheum Dis Clin North Am 35, 215-32.
4. Lawrence RC, Felson DT, Helmick CG et al. (2008) Estimates of the prevalence of arthritis and other rheumatic conditions in the United States. Part II. Arthritis Rheum 58, 26-35.
5. Perrot S, Vicaut E, Servant D, Ravaud P (2011) Prevalence of fibromyalgia in France: a multi-step study research combining national screening and clinical confirmation: The DEFI study (Determination of Epidemiology of FIbromyalgia). BMC Musculoskelet Disord 12, 224.
6. Wolfe F, Brahler E, Hinz A, Hauser W (2013) Fibromyalgia prevalence, somatic symptom reporting, and the dimensionality of polysymptomatic distress: results from a survey of the general population. Arthritis Care Res (Hoboken) 65, 777-85.
7. Bekelman JE, Li Y, Gross CP (2003) Scope and impact of financial conflicts of interest in biomedical research: a systematic review. JAMA 289, 454-65.
8. Buchkowsky SS, Jewesson PJ (2004) Industry sponsorship and authorship of clinical trials over 20 years. Ann Pharmacother 38, 579-85.
9. Patsopoulos NA, Ioannidis JP, Analatos AA (2006) Origin and funding of the most frequently cited papers in medicine: database analysis. BMJ 332, 1061-4.
10. Fontanarosa PB, Flanagin A, DeAngelis CD (2005) Reporting conflicts of interest, financial aspects of research, and role of sponsors in funded studies. JAMA 294, 110-1.
11. Chard JA, Tallon D, Dieppe PA (2000) Epidemiology of research into interventions for the treatment of osteoarthritis of the knee joint. Ann Rheum Dis 59, 414-8.
12. Yaphe J, Edman R, Knishkowy B, Herman J (2001) The association between funding by commercial interests and study outcome in randomized controlled drug trials. Fam Pract 18, 565-8.
13. Als-Nielsen B, Chen W, Gluud C, Kjaergard LL (2003) Association of funding and conclusions in randomized drug trials: a reflection of treatment effect or adverse events? JAMA 290, 921-8.
14. Lexchin J, Bero LA, Djulbegovic B, Clark O (2003) Pharmaceutical industry sponsorship and research outcome and quality: systematic review. BMJ 326, 1167-70.
15. Bhandari M, Busse JW, Jackowski D et al. (2004) Association between industry funding and statistically significant pro-industry findings in medical and surgical randomized trials. CMAJ 170, 477-80.
16. Montgomery JH, Byerly M, Carmody T et al. (2004) An analysis of the effect of funding source in randomized clinical trials of second generation antipsychotics for the treatment of schizophrenia. Control Clin Trials 25, 598-612.
17. Bourgeois FT, Murthy S, Mandl KD (2010) Outcome reporting among drug trials registered in ClinicalTrials.gov. Ann Intern Med 153, 158-66.
18. Ioannidis JP (2005) Why most published research findings are false. PLoS Med 2, e124.
19. Chalmers TC, Celano P, Sacks HS, Smith H Jr (1983) Bias in treatment assignment in controlled clinical trials. N Engl J Med 309, 1358-61.
20. Colditz GA, Miller JN, Mosteller F (1989) How study design affects outcomes in comparisons of therapy. I: Medical. Stat Med 8, 441-54.
21. Moher D, Pham B, Jones A et al. (1998) Does quality of reports of randomised trials affect estimates of intervention efficacy reported in meta-analyses? Lancet 352, 609-13.
22. Hill CL, LaValley MP, Felson DT (2002) Secular changes in the quality of published randomized clinical trials in rheumatology. Arthritis Rheum 46, 779-84.
23. Khan NA, Lombeida JI, Singh M, Spencer HJ, Torralba KD (2012) Association of industry funding with the outcome and quality of randomized controlled trials of drug therapy for rheumatoid arthritis. Arthritis Rheum 64, 2059-67.
24. Kunz R, Guyatt G (2005) Which patients to include in the analysis? Transfusion 46, 881-4.
25. Chan AW, Altman DG (2005) Epidemiology and reporting of randomised trials published in PubMed journals. Lancet 365, 1159-62.
26. Greenfield ML, Rosenberg AL, O'Reilly M, Shanks AM, Sliwinski MJ, Nauss MD (2005) The quality of randomized controlled trials in major anesthesiology journals. Anesth Analg 100, 1759-64.
27. Montori VM, Wang YG, Alonso-Coello P, Bhagra S (2006) Systematic evaluation of the quality of randomized controlled trials in diabetes. Diabetes Care 29, 1833-8.
28. Yuen SY, Pope JE (2008) Learning from past mistakes: assessing trial quality, power and eligibility in non-renal systemic lupus erythematosus randomized controlled trials. Rheumatology (Oxford) 47, 1367-72.
29. Altman DG (1996) Better reporting of randomised controlled trials: the CONSORT statement. BMJ 313, 570-1.
30. Altman DG, Schulz KF, Moher D et al. (2001) The revised CONSORT statement for reporting randomized trials: explanation and elaboration. Ann Intern Med 134, 663-94.
31. Moher D, Hopewell S, Schulz KF et al. (2010) CONSORT 2010 Explanation and Elaboration: updated guidelines for reporting parallel group randomised trials. J Clin Epidemiol 63, e1-37.
32. Moher D, Jones A, Lepage L., CONSORT Group (Consolitdated Standards for Reporting of Trials) (2001) Use of the CONSORT statement and quality of reports of randomized trials: a comparative before-and-after evaluation. JAMA 285, 1992-5.
33. Plint AC, Moher D, Morrison A et al. (2006) Does the CONSORT checklist improve the quality of reports of randomised controlled trials? A systematic review. Med J Aust 185, 263-7.
34. Hopewell S, Dutton S, Yu LM, Chan AW, Altman DG (2010) The quality of reports of randomised trials in 2000 and 2006: comparative study of articles indexed in PubMed. BMJ 340, c723.
35. Hewitt C, Hahn S, Torgerson DJ, Watson J, Bland JM (2005) Adequacy and reporting of allocation concealment: review of recent trials published in four general medical journals. BMJ 330, 1057-8.
36. Mills EJ, Wu P, Gagnier J, Devereaux PJ (2005) The quality of randomized trial reporting in leading medical journals since the revised CONSORT statement. Contemp Clin Trials 26, 480-7.
37. Boutron I, Tubach F, Giraudeau B, Ravaud P (2003) Methodological differences in clinical trials evaluating nonpharmacological and pharmacological treatments of hip and knee osteoarthritis. JAMA 290, 1062-70.
38. Ross JS, Mulvey GK, Hines EM, Nissen SE, Krumholz HM (2009) Trial publication after registration in ClinicalTrials.Gov: a cross-sectional analysis. PLoS Med 6, e1000144.
39. Ross JS, Tse T, Zarin DA, Xu H, Zhou L, Krumholz HM (2012) Publication of NIH funded trials registered in ClinicalTrials.gov: cross sectional analysis. BMJ 344, d7292.
40. Mathieu S, Boutron I, Moher D, Altman DG, Ravaud P (2009) Comparison of registered and published primary outcomes in randomized controlled trials. JAMA 302, 977-84.
41. Djulbegovic B, Lacevic M, Cantor A et al. (2000) The uncertainty principle and industry-sponsored research. Lancet 356, 635-8.
42. Hill CL, LaValley MP, Felson DT (2002) Discrepancy between published report and actual conduct of randomized clinical trials. J Clin Epidemiol 55, 783-6.
43. Devereaux PJ, Choi PT, El-Dika S et al. (2004) An observational study found that authors of randomized controlled trials frequently use concealment of randomization and blinding, despite the failure to report these methods. J Clin Epidemiol 57, 1232-6.