Disclosure of clinical trial results when product development is abandoned

Science Translational Medicine

Volumn 3, Issue 102, 2011, Pages

  Rogawski, Michael A ^a   Federo, Howard J ^b  

^a UNIVERSITY OF CALIFORNIA   (United States)

^b GEORGETOWN UNIVERSITY SCHOOL OF MEDICINE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ACCESS TO INFORMATION; CLINICAL RESEARCH; CLINICAL TRIAL (TOPIC); DATA BASE; DEVICE APPROVAL; DRUG APPROVAL; DRUG RESEARCH; FOOD AND DRUG ADMINISTRATION; HUMAN; INFORMATION DISSEMINATION; INFORMATION PROCESSING; INTERPERSONAL COMMUNICATION; MEDICAL INSTRUMENTATION; MEDICAL LITERATURE; NOTE; PATIENT SAFETY; PEER REVIEW; PRIORITY JOURNAL; PRODUCT DEVELOPMENT; RESEARCH ETHICS; SYSTEMATIC ERROR; TRANSLATIONAL RESEARCH; TREATMENT FAILURE; TREATMENT OUTCOME; UNITED STATES; PUBLICATION; PUBLISHING; REVIEW;

CLINICAL TRIALS AS TOPIC; DISCLOSURE; DRUG APPROVAL; HUMANS; PERIODICALS AS TOPIC; PUBLICATION BIAS; TREATMENT FAILURE;

EID: 80053302427     PISSN: 19466234     EISSN: 19466242     Source Type: Journal    
DOI: 10.1126/scitranslmed.3002939     Document Type: Note

References (32)

1. B. R. Cassileth, E. J. Lusk, D. S. Miller, S. Hurwitz, Attitudes toward clinical trials among patients and the public. JAMA 248, 968-970 (1982).
2. M. W. Ross, K. Jeff ords, J. Gold, Reasons for entry into and understanding of HIV/AIDS clinical trials: A preliminary study. AIDS Care 6, 77-82 (1994).
3. M. Slevin, J. Mossman, A. Bowling, R. Leonard, W. Steward, P. Harper, M. McIllmurray, N. Thatcher, Volunteers or victims: Patients' views of randomised cancer clinical trials. Br. J. Cancer 71, 1270-1274 (1995).
4. E. Novak, C. E. Seckman, R. D. Stewart, Motivations for volunteering as research subjects. J. Clin. Pharmacol. 17, 365-371 (1977).
5. E. L. Andresen, K. A. Wilson, A. Castillo, C. Koopman, Patient motivation for participating in clinical trials for depression: Validation of the motivation for clinical trials inventory-depression. Int. Clin. Psychopharmacol. 25, 7-16 (2010).
6. P. R. Ferguson, Clinical trials and healthy volunteers. Med. Law Rev. 16, 23-51 (2008).
7. E. J. Emanuel, D. Wendler, C. Grady, What makes clinical research ethical? JAMA 283, 2701-2711 (2000).
8. A. J. J. Wood, Progress and deficiencies in the registration of clinical trials. N. Engl. J. Med. 360, 824-830 (2009).
9. N. McGauran, B. Wieseler, J. Kreis, Y.-B. Schüler, H. Kölsch, T. Kaiser, Reporting bias in medical research - A narrative review. Trials 11, 37 (2010).
10. K. Rising, P. Bacchetti, L. Bero, Reporting bias in drug trials submitted to the Food and Drug Administration: Review of publication and presentation. PLoS Med. 5, e217, discussion e217 (2008).
11. E. Marshall, Antidepressants and children. Buried data can be hazardous to a company's health. Science 304, 1576-1577 (2004).
12. D. Eyding, M. Lelgemann, U. Grouven, M. Härter, M. Kromp, T. Kaiser, M. F. Kerekes, M. Gerken, B. Wieseler, Reboxetine for acute treatment of major depression: Systematic review and meta-analysis of published and unpublished placebo and selective serotonin reuptake inhibitor controlled trials. BMJ 341, c4737 (2010).
13. G. Schott, H. Pachl, U. Limbach, U. Gundert-Remy, K. Lieb, W. D. Ludwig, The financing of drug trials by pharmaceutical companies and its consequences: Part 2: A qualitative, systematic review of the literature on possible influences on authorship, access to trial data, and trial registration and publication. Dtsch. Arztebl. Int. 107, 295-301 (2010).
14. E. J. Carragee, A. J. Ghanayem, B. K. Weiner, D. J. Rothman, C. M. Bono, A challenge to integrity in spine publications: Years of living dangerously with the promotion of bone growth factors. Spine J. 11, 463-468 (2011).
15. E. J. Carragee, E. L. Hurwitz, B. K. Weiner, A critical review of recombinant human bone morphogenetic protein-2 trials in spinal surgery: Emerging safety concerns and lessons learned. Spine J. 11, 471-491 (2011).
16. E. H. Turner, A. M. Matthews, E. Linardatos, R. A. Tell, R. Rosenthal, Selective publication of antidepressant trials and its influence on apparent efficacy. N. Engl. J. Med. 358, 252-260 (2008).
17. C. J. Whittington, T. Kendall, P. Fonagy, D. Cottrell, A. Cotgrove, E. Boddington, Selective serotonin reuptake inhibitors in childhood depression: Systematic review of published versus unpublished data. Lancet 363, 1341-1345 (2004).
18. D. A. Zarin, A. Bergeris, N. C. Ide, T. Tse, ClinicalTrials.gov; A report to the Board of Scientific Counselors (U.S. National Library of Medicine Technical Report LHNCBCTR-2005-003, May 2005). http://www.lhncbc.nlm.nih.gov/ lhc/docs/reports/2005/tr2005003.pdf.
19. D. A. Zarin, T. Tse, R. J. Williams, R. M. Califf, N. C. Ide, The ClinicalTrials.gov results database - Update and key issues. N. Engl. J. Med. 364, 852-860 (2011).
20. A. K. Asamoah, J. M. Sharfstein, Transparency at the Food and Drug Administration. N. Engl. J. Med. 362, 2341-2343 (2010).
21. E. H. Turner, Reboxetine in depression. All the relevant data? BMJ 341, c6487 (2010).
22. Pharmaceutical Research and Manufacturers of America, a trade association representing some U.S. firms, supports the posting of summary results of clinical trials of investigational products whose development programs are discontinued, regardless of outcome, within one year of discontinuation and also journal publication if the information is felt to be of significant medical importance. Principles on Conduct of Clinical Trials and Communication of Clinical Trial Results (revised April 2009). http://www.phrma.org/about/ principles-guidelines/clinicaltrials.
23. R. E. Becker, N. H. Greig, Lost in translation: Neuropsychiatric drug development. Sci. Transl. Med. 2, 61rv6 (2010).
24. Public Meeting on Expansion of the Clinical Trial Registry and Results Data Bank, Federal Register 74 (54) (23 March 2009), pp. 12138-12140. http://prsinfo.clinicaltrials.gov/Clinical-Trials-FRN31609-POST.pdf.
25. E. A. Turner, N. J. Moaleji, B. L. Arnold Closing a loophole in the FDA amendments act. Science 322, 44-46 (2008).
26. Expanded Registration and Results Reporting at ClinicalTrials. gov (Unified Agenda of Federal Regulatory and Deregulatory Actions, Spring 2011. Regulatory Identification Number: 0925-AA55). http://www.reginfo.gov/public/do/ eAgendaViewRule?pubId=201104&RIN=0925-AA55.
27. Anticipated and unanticipated serious adverse events are required to be reported, grouped by organ system, as well as other (nonserious) anticipated and unanticipated adverse events that exceed a frequency of 5% within any arm of the clinical trial, also grouped by organ system.
28. FDAAA 801 requires ClinicalTrials.gov to link to Medline citations of any publications "focused on the results of an applicable clinical trial." Inclusion of the ClinicalTrials. gov unique identifer in journal publications will allow readers access to the basic results data, which may be more detailed than those reported in the journal article. It will also permit the National Library of Medicine to fulfill its legal mandate to provide applicable Medline links. The International Committee of Medical Journal Editors recommends that a clinical trial registration number be included at the end of the article's abstract. http://www.icmje.org/publishing-10register.html.
29. I. Boutron, S. Dutton, P. Ravaud, D. G. Altman, Reporting and interpretation of randomized controlled trials with statistically nonsignificant results for primary outcomes. JAMA 303, 2058-2064 (2010).
30. K. Lee, P. Bacchetti, I. Sim, Publication of clinical trials supporting successful new drug applications: A literature analysis. PLoS Med. 5, e191 (2008).
31. R. S. Tuma, New law may be having some eff ect on publication bias. J. Natl. Cancer Inst. 102, 290-292 (2010).
32. Acknowledgments: The authors thank B. Lo for suggestions, T. Tse for advice and review of the manuscript, and E. D. Pellegrino for comments. Competing interests: M.A.R. is a special government employee of the U.S. Food and Drug Administration. The authors declare no other relevant competing interests.