Accessibility of trial reports for drugs stalling in development: A systematic assessment of registered trials

BMJ (Online)

Volumn 350, Issue , 2015, Pages

  Hakala, Amanda ^a   Kimmelman, Jonathan ^a   Carlisle, Benjamin ^a   Freeman, Georgina ^a   Fergusson, Dean ^b  

^a MCGILL UNIVERSITY   (Canada)

^b OTTAWA HOSPITAL RESEARCH INSTITUTE   (Canada)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; COHORT ANALYSIS; COST BENEFIT ANALYSIS; DRUG APPROVAL; DRUG MARKETING; DRUG RESEARCH; FOOD AND DRUG ADMINISTRATION; FUNDING; GEOGRAPHY; HUMAN; LICENSING; POLICY; PRIORITY JOURNAL; PUBLICATION; REGISTER; UNLICENSED DRUG USE; ACCESS TO INFORMATION; CLINICAL TRIAL (TOPIC); DRUG DEVELOPMENT; PUBLISHING; STATISTICS AND NUMERICAL DATA;

DRUG;

ACCESS TO INFORMATION; CLINICAL TRIALS AS TOPIC; DRUG APPROVAL; DRUG DISCOVERY; HUMANS; PHARMACEUTICAL PREPARATIONS; PUBLISHING;

EID: 84926288672     PISSN: 09598146     EISSN: 17561833     Source Type: Journal    
DOI: 10.1136/bmj.h1116     Document Type: Article

References (21)

1. Rising K, Bachetti P, Bero L. Reporting bias in drug trials submitted to the Food and Drug Administration: review of publication and presentation. PLOS Med 2008;5:e217.
2. Hart B, Lundh A, Bero L. Effect of reporting bias on meta-analyses of drug trails: reanalysis of meta-analyses. BMJ 2012;344:d7202.
3. Goodyear M. Learning from the TGN1412 trial. BMJ 2006;332:677-8.
4. US National Institutes of Health. FDAAA 801 requirements: are there penalties if I fail to register or submit results? Clinicaltrials.gov. http://clinicaltrials.gov/ct2/manage-recs/fdaaa#AreTherePenalties.
5. Hay M, Thomas DW, Craighead JL, Economides C, Rosenthal J. Clinical development success rates for investigational drugs. Nat Biotechnol 2014;32:40-51.
6. Hudson KL, Collins FS. Sharing and reporting the results of clinical trials. JAMA 2015;313:355-6.
7. 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-results-submission.
8. Jones CW, Handler L, Crowell KE, Keil LG, Weaver, MA, Platts-Mills TF. Non-publication of large randomized clinical trials: cross sectional analysis. BMJ 2013;347:f6104.
9. Lee K, Bacchetti P, Sim I. Publication of clinical trials supporting successful new drug applications: a literature analysis. PLOS Med. 2008;5:e191.
10. Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council of Canada, Social Sciences and Humanities Research Council of Canada. Tri-Council policy statement: ethical conduct for research involving humans, December 2010. www.pre.ethics.gc.ca/pdf/eng/tcps2/TCPS-2-FINAL-Web.pdf.
11. World Medical Association. Declaration of Helsinki: ethical principles for medical research involving human subjects. 2013. www.wma.net/en/30publications/10policies/b3/index.html.
12. Doshi P, Jefferson T. The first 2 years of the European Medicines Agency's policy on access to documents: secret no longer. JAMA Intern Med 2013;173:380-2.
13. Rogawski MA, Federoff HJ. Disclosure of clinical trial results when product development is abandoned. Sci Transl Med 2011;3:102cm29.
14. Deftereos SN, Andronis C, Friedla EJ, Persidis A, Persidis A. Drug repurposing and adverse event prediction using high-throughput literature analysis. Wiley Interdiscip Rev Syst Biol Med 2011;3:323-34.
15. Burton TM. US to see new uses for abandoned drugs. Wall Street Journal 4 May 2012. http://online.wsj.com/news/articles/SB10001424052702303877604577382392599422600.
16. NIH Office of Science Policy. NIH-industry roundtable: exploring new uses for abandoned and approved therapeutics. April 21-22, 2011. Executive summary. www.ncats.nih.gov/files/exploring-new-uses-for-abandoned-and-approved-therapeutics.pdf.
17. Karve S, Werner ME, Sukumar R, Cummings ND, Copp JA, Wang EC, et al. Revival of the abandoned therapeutic wortmannin by nanoparticle drug delivery. Proc Natl Acad Sci USA 2012;109:8230-5.
18. Allarakhia M. Open-source approaches for the repurposing of existing or failed candidate drugs: learning from and applying the lessons across diseases. Drug Des Dev Ther 2013;7:753-66.
19. Wadman M. NIH funds effort to resurrect abandoned drugs for new uses. Nat News Blog 18 June 2013. http://blogs.nature.com/news/2013/06/nih-funds-effort-to-resurrect-abandoned-drugs-for-new-uses.html.
20. Peart KN. Yale programs agreement with Johnson & Johnson allows broad access to clinical trial data. Yale News 30 January 2014. http://news.yale.edu/2014/01/30/yale-program-s-agreement-johnson-johnson-allows-broad-access-clinical-trial-data.
21. European Parliament News. Clinical trials: clearer rules, better protection for patients. Plenary Session Press Release 2 April 2014. www.europarl.europa.eu/news/en/newsroom/content/20140331IPR41186/html/Clinical-trials-clearer-rules-better-protection-for-patients.