Factors associated with reporting results for pulmonary clinical trials in ClinicalTrials.gov

Clinical Trials

Volumn 15, Issue 1, 2018, Pages 87-94

  Riley, Isaretta L ^a   Boulware, L Ebony ^a,b   Sun, Jie Lena ^b   Chiswell, Karen ^b   Que, Loretta G ^a   Kraft, Monica ^c   Todd, Jamie L ^a,b   Palmer, Scott M ^a,b   Anderson, Monique L ^a,b  

^a DUKE UNIVERSITY SCHOOL OF MEDICINE   (United States)

^b DUKE CLINICAL RESEARCH INSTITUTE   (United States)

^c UNIVERSITY OF ARIZONA COLLEGE OF MEDICINE   (United States)

Author keywords

asthma; cancer; chronic obstructive pulmonary disease; clinical trials; ClinicalTrials.gov; compliance; Food and Drug Administration Amendments Act; Policy; pulmonary; transparency

Indexed keywords

ARTICLE; ASTHMA; CHRONIC OBSTRUCTIVE LUNG DISEASE; CLINICAL TRIAL (TOPIC); DRUG INDUSTRY; FUNDING; HUMAN; LUNG DISEASE; MANDATORY REPORTING; PRIORITY JOURNAL; REGISTRATION; RESPIRATORY TRACT DISEASE; RESPIRATORY TRACT TUMOR; ALGORITHM; DOCUMENTATION; FACTUAL DATABASE; FINANCIAL MANAGEMENT; FOOD AND DRUG ADMINISTRATION; ORGANIZATION AND MANAGEMENT; PROCEDURES; REGRESSION ANALYSIS; STANDARDS; STATISTICS AND NUMERICAL DATA; UNITED STATES;

ALGORITHMS; CLINICAL TRIALS AS TOPIC; DATABASES, FACTUAL; DOCUMENTATION; FINANCING, ORGANIZED; HUMANS; REGRESSION ANALYSIS; RESPIRATORY TRACT DISEASES; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 85041554382     PISSN: 17407745     EISSN: 17407753     Source Type: Journal    
DOI: 10.1177/1740774517740352     Document Type: Article

References (37)

1. Dechartres A, Riveros C, Harroch M. Characteristics and public availability of results of clinical trials on rare diseases registered at ClinicalTrials.gov. JAMA Intern Med 2016; 176: 556–558.
2. Zarin DA, Tse T, Williams RJ. Trial reporting in ClinicalTrials.gov—the final rule. N Engl J Med 2016; 375: 1998–2004.
3. Public Law 105–115. Food and Drug Administration Modernization Act of 1997. Adopted 21 November 1997, https://www.gpo.gov/fdsys/pkg/PLAW-105publ115/pdf/PLAW-105publ115.pdf (1997, accessed 12 October 2017).
4. Pansieri C, Pandolfini C, Bonati M., The evolution in registration of clinical trials: a chronicle of the historical calls and current initiatives promoting transparency. Eur J Clin Pharmacol 2015; 71: 1159–1164.
5. Laine C, Horton R, De Angelis CD. Clinical trial registration—looking back and moving ahead. N Engl J Med 2007; 356: 2734–2736.
6. Tse T, Williams RJ, Zarin DA., Reporting “basic results” in ClinicalTrials.gov. Chest 2009; 136: 295–303.
7. Food Drug Administration. Food and Drug Administration Amendments Act (FDAAA) of 2007, https://www.gpo.gov/fdsys/pkg/PLAW-110publ85/html/PLAW-110publ85.htm (2007, accessed 12 October 2017)
8. Zarin DA, Tse T, Sheehan J., The proposed rule for US clinical trial registration and results submission. N Engl J Med 2015; 372: 174–180.
9. Shalowitz DI, Miller FG., Disclosing individual results of clinical research: implications of respect for participants. JAMA 2005; 294: 737–740.
10. Kesselheim AS, Mello MM., Confidentiality laws and secrecy in medical research: improving public access to data on drug safety. Health Aff 2007; 26: 483–491.
11. Zarin DA, Tse T., Moving towards transparency of clinical trials. Science 2008; 319: 1340–1342.
12. Karassa FB, Ioannidis JP., Clinical trials: a transparent future for clinical trial reporting. Nat Rev Rheumatol 2015; 11: 324–326.
13. Kramer DB, Cutlip DE., Regulatory science: trust and transparency in clinical trials of medical devices. Nat Rev Cardiol 2015; 12: 503–504.
14. Mintzes B, Lexchin J., Clinical trial transparency: many gains but access to evidence for new medicines remains imperfect. Br Med Bull 2015; 116: 43–53.
15. World Medical Association. World Medical Association Declaration of Helsinki. Ethical principles for medical research involving human subjects. Bull World Health Organ 2001; 79: 373–374.
16. Anderson ML, Chiswell K, Peterson ED. Compliance with results reporting at ClinicalTrials.gov. N Engl J Med 2015; 372: 1031–1039.
17. Nguyen TA, Dechartres A, Belgherbi S. Public availability of results of trials assessing cancer drugs in the United States. J Clin Oncol 2013; 31: 2998–3003.
18. Jones CW, Handler L, Crowell KE. Non-publication of large randomized clinical trials: cross sectional analysis. BMJ 2013; 347: f6104.
19. Todd JL, White KR, Chiswell K. Using ClinicalTrials.gov to understand the state of clinical research in pulmonary, critical care, and sleep medicine. Ann Am Thorac Soc 2013; 10: 411–417.
20. ClinicalTrials.gov. FDAAA 801 requirements, https://clinicaltrials.gov/ct2/manage-recs/fdaaa (accessed 12 October 2017).
21. US and National Library of Medicine. 2015 medical subject headings, https://www.nlm.nih.gov/pubs/techbull/so14/so14_2015_mesh_avail.html (accessed 12 October 2017).
22. Califf RM, Zarin DA, Kramer JM. Characteristics of clinical trials registered in ClinicalTrials.gov, 2007–2010. JAMA 2012; 307: 1838–1847.
23. Tasneem A, Aberle L, Ananth H. The database for aggregate analysis of ClinicalTrials.gov (AACT) and subsequent regrouping by clinical specialty. PLoS ONE 2012; 7: e33677.
24. Law MR, Kawasumi Y, Morgan SG. Despite law, fewer than one in eight completed studies of drugs and biologics are reported on time on ClinicalTrials.gov. Health Aff 2011; 30: 2338–2345.
25. Hudson KL, Lauer MS, Collins FS., Toward a new era of trust and transparency in clinical trials. JAMA 2016; 316: 1353–1354.
26. Department of Health Human Services. Clinical trials registration and results submission. Fed Regist 2014; 79: 69566–69680.
27. National Institutes of Health. Announcement of a draft NIH policy on dissemination of NIH-funded clinical trial information. Fed Regist 2015; 80: 8096–8098.
28. Loder E, Groves T., The BMJ requires data sharing on request for all trials. BMJ 2015; 350: h2373.
29. Morley G., Regulatory writing: new developments in public disclosure of clinical trials. Med Writ 2015; 24: 153–154.
30. Turner EH, Matthews AM, Linardatos E. Selective publication of antidepressant trials and its influence on apparent efficacy. N Engl J Med 2008; 358: 252–260.
31. Tripathy D., Negative is positive: a plea to publish all studies regardless of outcome. Am J Hematol Oncol 2015; 11: 30–31.
32. World Health Organization. WHO statement on public disclosure of clinical trial results, http://www.who.int/ictrp/results/reporting/en/ (2015, accessed 12 October 2017).
33. Tse T, Zarin DA., Clinical trial registration and results reporting. Update 2009, https://prsinfo.clinicaltrials.gov/publications/FDLI-Update_2009_508.pdf (2009, accessed 12 October 2017).
34. Zarin DA, Tse T, Williams RJ. The ClinicalTrials. gov results database—update and key issues. N Engl J Med 2011; 364: 852–860.
35. Gill CJ., How often do US-based human subjects research studies register on time, and how often do they post their results? A statistical analysis of the Clinicaltrials.gov database. BMJ 2012; 2: e001186.
36. Prayle AP, Hurley MN, Smyth AR., Compliance with mandatory reporting of clinical trial results on ClinicalTrials.gov: cross sectional study. BMJ 2012; 344: d7373.
37. Taichman DB, Backus J, Baethge C. Sharing clinical trial data—a proposal from the International Committee of Medical Journal Editors. N Engl J Med 2016; 374: 384–386.