Clinical trial registration, reporting, publication and FDAAA compliance: A cross-sectional analysis and ranking of new drugs approved by the FDA in 2012

BMJ Open

Volumn 5, Issue 11, 2015, Pages

  Miller, Jennifer E ^a   Korn, David ^b   Ross, Joseph S ^c,d,e  

^a NEW YORK UNIVERSITY SCHOOL OF MEDICINE   (United States)

^b HARVARD MEDICAL SCHOOL   (United States)

^c YALE UNIVERSITY SCHOOL OF MEDICINE   (United States)

^d YALE UNIVERSITY   (United States)

^e YALE NEW HAVEN HOSPITAL   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

NEW DRUG;

ARTICLE; BIOTECHNOLOGY; CLINICAL PHARMACOLOGY; CLINICAL TRIAL (TOPIC); DATA BASE; DRUG APPROVAL; DRUG INDUSTRY; DRUG PACKAGING; FOOD AND DRUG ADMINISTRATION; HUMAN; MEDICAL ETHICS; MEDICAL LITERATURE; MEDICAL PRACTICE; MEDICAL RESEARCH; MEDLINE; OUTCOME ASSESSMENT; PHARMACEUTICS; PHASE 1 CLINICAL TRIAL (TOPIC); PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); PUBLICATION; SCIENTIST; CROSS-SECTIONAL STUDY; ETHICS; FACTUAL DATABASE; INTERPERSONAL COMMUNICATION; LEGISLATION AND JURISPRUDENCE; PUBLIC HEALTH; RESEARCH; STANDARDS; STATISTICS AND NUMERICAL DATA; UNITED STATES;

CLINICAL TRIALS AS TOPIC; CROSS-SECTIONAL STUDIES; DATABASES, FACTUAL; DISCLOSURE; DRUG APPROVAL; HUMANS; PUBLIC HEALTH; PUBLICATIONS; RESEARCH REPORT; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84946827399     PISSN: None     EISSN: 20446055     Source Type: Journal    
DOI: 10.1136/bmjopen-2015-009758     Document Type: Article

References (24)

1. Jones CW, Handler L, Crowell KE, et al. Non-publication of large randomized clinical trials: cross sectional analysis. BMJ 2013;347:f6104.
2. McGee RG, Su M, Kelly PJ, et al. Trial registration and declaration of registration by authors of randomized controlled trials. Transplantation 2011;92:1094-100.
3. Guo SW, Evers JLH. Lack of transparency of clinical trial endometriosis. Obstet Gynecol 2013;121:1281-90.
4. Lee K, Bacchetti P, Sim I. Publication of clinical trials supporting successful new drug applications: a literature analysis. PLoS Med 2008;5:e191.
5. Ross JS, Mulvey GK, Hines EM, et al. Trial publication after registration in ClinicalTrials.Gov: a cross-sectional analysis. PLoS Med 2009;6:e1000144.
6. Ross JS, Tse T, Zarin DA, et al. Publication of NIH funded trials registered in ClinicalTrials.gov: cross sectional analysis. BMJ 2012;344:d7292.
7. Anderson ML, Chiswell K, Peterson ED, et al. Compliance with results reporting at ClinicalTrials.gov. N Engl J Med 2015;372:1031-9.
8. Turner EH, Matthews AM, Linardatos E, et al. Selective publication of antidepressant trials and its influence on apparent efficacy. N Engl J Med 2008;358:252-60.
9. Melander H, Ahlqvist-Rastad J, Meijer G, et al. Evidence b(i)ased medicine - selective reporting from studies sponsored by pharmaceutical industry: review of studies in new drug applications. BMJ 2003;326:1171-3.
10. Dickersin K, Min YI. NIH clinical trials and publication bias. Online J Curr Clin Trials 1993;28:doc50.
11. Easterbrook PJ, Berlin JA, Gopalan R, et al. Publication bias in clinical research. Lancet 1991;337:867-72.
12. Federal Register. Clinical trials registration and results submission: notice of proposed rulemaking. https://www.federalregister.gov/articles/2014/11/21/2014-26197/clinical-trials-registration-and-resultssubmission (accessed 1 Aug 2015).
13. Zarin DA, Tse T, Sheehan J. The proposed rule for U.S. clinical trial registration and results submission. N Engl J Med 2015;372:174-80.
14. National Institutes of Health. NOT-OD-15-019: NIH request for public comments on the draft NIH policy on dissemination of NIH-funded clinical trial information. 2014. http://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-019.html
15. Food and Drug Administration. FY 2012 Innovative Drug Approvals. http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/ucm276385.htm (accessed Aug 2015).
16. Food and Drug Administration, Center for Drug Evaluation and Research. Impact, Innovation, Predictability, Access: 2012 Novel New Drugs Summary, January 2013. http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/DrugInnovation/UCM337830.pdf (accessed Aug 2015).
17. http://www.genengnews.com/gen-articles/gen-39-s-list-of-top-pharma-and-biotech-firms/5109/?kwrd=Top 15 biotech of 2013 (accessed Aug 2015).
18. Food and Drug Administration Amendments Act of 2007. US Public Law 110-85. (2007, Sept 27); 21 USC 301.
19. ClinicalTrials.gov. FDAAA 801 requirements. https://clinicaltrials.gov/ct2/manage-recs/fdaaa#WhichTrialsMustBeRegistered
20. Federal Policy for the Protection of Human Subjects. 45 CFR §46. 2009.
21. World Health Organization. WHO Statement on Public Disclosure of Clinical Trial Results. http://www.who.int/ictrp/results/reporting (accessed 14 Apr 2015).
22. Miller JE. Bioethical accreditation or rating needed to restore trust in pharma. Nat Med 2013;19:261.
23. Miller JE. How a clinical trial registry became a symbol of misinformation. Hastings Cent Rep 2013;43:11-12.
24. Miller JE. From bad pharma to good pharma: aligning market forces with good and trustworthy practices through accreditation, certification and rating. J Law Med Ethics 2013;41:601-10.