Clinical trial transparency: A reassessment of industry compliance with clinical trial registration and reporting requirements in the United States

BMJ Open

Volumn 7, Issue 9, 2017, Pages

  Lassman, Scott M ^a   Shopshear, Olivia M ^b   Jazic, Ina ^c   Ulrich, Jocelyn ^b   Francer, Jeffrey ^b  

^a Goodwin Procter LLP   (United States)

^b Pharmaceutical Research and Manufacturers of America   (United States)

^c HARVARD SCHOOL OF PUBLIC HEALTH   (United States)

Author keywords

clinical trials; ethics (see medical ethics); health policy; law (see medical law); public health

Indexed keywords

AFLIBERCEPT; APIXABAN; AXITINIB; BEDAQUILINE; BOSUTINIB; COBICISTAT PLUS ELVITEGRAVIR PLUS EMTRICITABINE PLUS TENOFOVIR DISOPROXIL; HAEMOPHILUS INFLUENZAE TYPE B MENINGOCOCCUS TETANUS VACCINE; PASIREOTIDE; PERTUZUMAB; REGORAFENIB; TAFLUPROST; TALIGLUCERASE ALFA; TERIFLUNOMIDE; TOFACITINIB; VISMODEGIB;

ARTICLE; CLINICAL PROTOCOL; CLINICAL RESEARCH; CLINICAL TRIAL (TOPIC); CROSS-SECTIONAL STUDY; DATA ANALYSIS; DRUG APPROVAL; DRUG INDUSTRY; DRUG LEGISLATION; FOOD AND DRUG ADMINISTRATION; HUMAN; OUTCOME ASSESSMENT; PROTOCOL COMPLIANCE; UNITED STATES; ACCESS TO INFORMATION; INTERPERSONAL COMMUNICATION; LEGISLATION AND JURISPRUDENCE; REGISTER; STATISTICS AND NUMERICAL DATA;

ACCESS TO INFORMATION; CLINICAL TRIALS AS TOPIC; CROSS-SECTIONAL STUDIES; DISCLOSURE; DRUG APPROVAL; DRUG INDUSTRY; HUMANS; REGISTRIES; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 85029850050     PISSN: None     EISSN: 20446055     Source Type: Journal    
DOI: 10.1136/bmjopen-2016-015110     Document Type: Article

References (16)

1. Miller JE, Korn D, Ross JS. Clinical trial registration, reporting, publication and FDAAA compliance: a cross-sectional analysis and ranking of new drugs approved by the FDA in 20125:e009758. BMJ Open 2015;5:e009758.
2. Mello MM, Francer JK, Wilenzick M, et al. Preparing for responsible sharing of clinical trial data. N Engl J Med 2013;369:1651-8.
3. De Angelis C, Drazen JM, Frizelle FA, et al. Clinical trial registration: a statement from the International Committee of Medical Journal Editors. N Engl J Med 2004;351:1250-1.
4. World Health Organization, WHO Statement on Public Disclosure of Clinical Trial Results (2015). http://www. who. int/ictrp/results/reporting/en/(accessed 5 Mar 2017).
5. WMA Declaration of Helsinki-Ethical Principles for Medical Research Involving Human Subjects, Ş 36. 2013. available at https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/(accessed May 17, 2017).
6. PhRMA Principles on Conduct of Clinical Trials and Communication of Clinical Trial Results. P 2004;20. (emphasis added).
7. Principles for Responsible Clinical Trial Data Sharing. 2013. available at Error! Hyperlink reference not valid. (accessed March 5, 2017).
8. Food and Drug Administration Amendments Act of 2007 (FDAAA), Public Law No. 110-85, Ş 801, 121 Stat. 904, 2007. (codifed at 42 U.S.C. Ş 282).
9. NIH. Clinicaltrial. gov Registry and results database home page. https://clinicaltrials.gov/ct2/home (accessed 5 Mar 2017).
10. See elaboration of defnitions of responsible party and applicable clinical trial, pp. 7-8 [Draft] ("NIH defnitions guidance". https://pr sinfo.clinicaltrials.gov/ElaborationsOnDefnitions.pdf 2009. (accessed March 5, 2017).
11. ClinicalTrials. gov Protocol Registration Data Element Defnitions for Interventional and Observational Studies. 2017. available at https://prsinfo.clinicaltrials.gov/defnitions.html (accessed March 5, 2017).
12. Clinical Trials Registration and Results Information Submission; Final Rule (NIH Final Rule), 81 Fed. Reg. 64982, 2016. (codifed at 42 C.F.R. Part 11).
13. Anderson ML, Chiswell K, Peterson ED, et al. Compliance with results reporting at ClinicalTrials. gov. N Engl J Med 2015;372:1031-9.
14. Miller JE, Korn D, Ross JS. Data from: Clinical trial registration, reporting, publication and FDAAA compliance: a cross-sectional analysis and ranking of new drugs approved by the FDA in 2012. Dryad Digital Repository 2015.
15. See Drugs@FDA, http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index. cfm (accessed 5 Mar 2017).
16. Hudson KL, Collins FS. Sharing and Reporting the Results of Clinical Trials. JAMA 2015;313:355.