Lack of clinical trial data transparency and current solutions
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Publié-e :
juin 8, 2017
Mots-clés :
Clinical Trials, Patient Safety, Selective Reporting
Contenu principal de l'article
Résumé
An ongoing challenge in clinical research is the inaccessibility of clinical trial data, which prevents physicians from making an informed decision with regards to patient care. The U.S. Food and Drug Administration (FDA) as well as the World Health Organization (WHO) recently called for all trial data to be registered and made publically available. However, this issue is still ongoing and there are several measures currently being enforced to rectify these concerns. Potential solutions, such as regulations, campaigns, and possible conse- quences, for increasing transparency in clinical trial data will be discussed.
RÉSUMÉ
L’inaccessibilité des données provenant d’essais cliniques constitue un défi constant en recherche clinique, puisqu’elle empêche les médecins de prendre des décisions éclairées quant aux soins de leurs patients. Récemment, le Secrétariat américain aux produits alimentaires et pharmaceutiques (FDA) ainsi que l’Organisation mondiale de la Santé (OMS) ont demandé que toutes les données d’essais cliniques soient enregistrées et mises à la disposition du public. Toutefois, ce problème persiste et plusieurs mesures ont été mises en place pour répondre à ces préoccupations. Des solutions possibles dont des réglementations, des campagnes et des sanctions possibles pour améliorer la transparence en ce qui concerne les données d’essais cliniques seront discutées.
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Références
1. Umscheid CA, Margolis DJ, Grossman CE. Key Concepts of Clinical Trials: A Narrative Review. Postgrad Med. 2011;123(5):194-204.
2. Brassington I. The ethics of reporting all the results of clinical trials. Br Med Bull. 2017;121(1)19-29.
3. Gøtzsche PC. Why we need easy access to all data from all clinical trials and how to accomplish it. Trials. 2011;12(1):249.
4. Dickersin K, Chalmers I. Recognizing, investigating and dealing with incomplete and biased reporting of clinical research: from Francis Bacon to the WHO. J R Soc Med. 2011;104(12):532-8.
5. Wynia M, Boren D. Better regulation of industry-sponsored clinical trials is long overdue. J Law Med Ethics. 2009;37(3):410-9.
6. Richardson E. Health Policy Brief: Transparency in Clinical Research [Internet]. Health Affairs. 2016 Jan 14. Available from: http://healthaffairs.org/ healthpolicybriefs/brief_pdfs/healthpolicybrief_150.pdf
7. Krumholz HM, Ross JS, Presler AH, et al. What have we learnt from Vioxx? BMJ. 2007;334(7585):120-3.
8. Madigan D, Sigelman DW, Mayer JW, et al. Under-reporting of cardiovascular events in the rofecoxib Alzheimer disease studies. Am Heart J. 2004;164(2):186-93.
9. Jasarevic T. WHO call for increased transparency in medical research [Internet]. Geneva: World Health Organization; 2015 Apr 14. Available from: http://www.who.int/mediacentre/news/notes/2015/medical-research- transparency/en/
10. WHO Statement on Public Disclosure of Clinical Trial Results [Internet]. World Health Organization; 2015 Apr 9. Available from: http://www.who. int/ictrp/results/reporting/en/
11. Food and Drug Administration Amendments Act of 2007 [Internet]. U.S Public Law 110-85. 2007 Sept 27. Available from: http://www.gpo.gov/fdsys/ pkg/PLAW-110publ85/pdf/PLAW-110publ85.pdf
12. Trends, Charts, and Maps [Internet]. Clinicaltrials.gov, U.S. National Insti- tutes of Health. 2016 Feb. Available from: https://clinicaltrials.gov/ct2/resources/trends
13. Jones CW, Handler L, Crowell KE, et al. Non-publication of large randomized clinical trials: cross sectional analysis. BMJ. 2013;347:f6104.
14. 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 2012. BMJ Open. 2015;5(11):e009758.
15. FDAAA 801 Requirements [Internet]. Clinicaltrials.gov, U.S. National Institutes of Health. 2017 Feb. Available from: https://clinicaltrials.gov/ct2/ manage-recs/fdaaa
16. Krumholz, HM. The Yale Open Data Access (YODA) Project – A Mechanism for Data Sharing. N Engl J Med. 2016;375:403-5.
17. Powell-Smith A, Goldacre B. The TrialsTracker: Automated ongoing monitoring of failure to share clinical trial results by all major companies and research institutions. F1000Research. 2016;5:2629.
18. Hol D. ‘We’ve been deceived’: Many clinical trial results are never published [Internet]. CBC News, Canada; 2016 Nov 24. Available from: http://www. cbc.ca/news/health/clinical-trial-results-not-published-1.3865785
19. Goldacre B. How to Get All Trials Reported: Audit, Better Data, and Individual Accountability. PLOS Medicine. 2015;12(4):e1001821.
20. Ghersi D, Clarke M, Berlin J, et al. Reporting the findings of clinical trials: a discussion paper [Internet]. Bulletin of the World Health Organization. 2008;86(6):417-96.
21. AllTrials [Internet]. London, UK. 2013 Sept. Available from: http://www.all- trials.net/find-out-more/all-trials/
22. Lane, S. AllTrials campaign and petition support greater clinical trial transparency. [Internet] Elsevier. 2014 June 23. Available from: https://www. elsevier.com/connect/alltrials-campaign-supports-greater-clinical-trial- transparency
23. Thomas K, Schmidt MS. Glaxo Agrees to Pay $3 Billion in Fraud Settlement. [Internet] The New York Times. 2012 July 2. Available from: http://www.nytimes.com/2012/07/03/business/glaxosmithkline-agrees-to-pay-3-billion- in-fraud-settlement.html
24. Tucker K, Branson J, Dilleen M, et al. Protecting patient privacy when sharing patient-level data from clinical trials. BMC Med Res Methodol. 2016;16(1):77.
25. Price WN, Minssen T. Will clinical trial data disclosure reduce incentives to develop new uses of drugs? Nat Publ Gr. 2015;33(7):685-6.
26. Roin BN. Solving the problem of new uses [Internet]. Social Science Research Network. 2013 October 10. Available from: http:// dx.doi.org/10.2139/ ssrn.2337821
2. Brassington I. The ethics of reporting all the results of clinical trials. Br Med Bull. 2017;121(1)19-29.
3. Gøtzsche PC. Why we need easy access to all data from all clinical trials and how to accomplish it. Trials. 2011;12(1):249.
4. Dickersin K, Chalmers I. Recognizing, investigating and dealing with incomplete and biased reporting of clinical research: from Francis Bacon to the WHO. J R Soc Med. 2011;104(12):532-8.
5. Wynia M, Boren D. Better regulation of industry-sponsored clinical trials is long overdue. J Law Med Ethics. 2009;37(3):410-9.
6. Richardson E. Health Policy Brief: Transparency in Clinical Research [Internet]. Health Affairs. 2016 Jan 14. Available from: http://healthaffairs.org/ healthpolicybriefs/brief_pdfs/healthpolicybrief_150.pdf
7. Krumholz HM, Ross JS, Presler AH, et al. What have we learnt from Vioxx? BMJ. 2007;334(7585):120-3.
8. Madigan D, Sigelman DW, Mayer JW, et al. Under-reporting of cardiovascular events in the rofecoxib Alzheimer disease studies. Am Heart J. 2004;164(2):186-93.
9. Jasarevic T. WHO call for increased transparency in medical research [Internet]. Geneva: World Health Organization; 2015 Apr 14. Available from: http://www.who.int/mediacentre/news/notes/2015/medical-research- transparency/en/
10. WHO Statement on Public Disclosure of Clinical Trial Results [Internet]. World Health Organization; 2015 Apr 9. Available from: http://www.who. int/ictrp/results/reporting/en/
11. Food and Drug Administration Amendments Act of 2007 [Internet]. U.S Public Law 110-85. 2007 Sept 27. Available from: http://www.gpo.gov/fdsys/ pkg/PLAW-110publ85/pdf/PLAW-110publ85.pdf
12. Trends, Charts, and Maps [Internet]. Clinicaltrials.gov, U.S. National Insti- tutes of Health. 2016 Feb. Available from: https://clinicaltrials.gov/ct2/resources/trends
13. Jones CW, Handler L, Crowell KE, et al. Non-publication of large randomized clinical trials: cross sectional analysis. BMJ. 2013;347:f6104.
14. 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 2012. BMJ Open. 2015;5(11):e009758.
15. FDAAA 801 Requirements [Internet]. Clinicaltrials.gov, U.S. National Institutes of Health. 2017 Feb. Available from: https://clinicaltrials.gov/ct2/ manage-recs/fdaaa
16. Krumholz, HM. The Yale Open Data Access (YODA) Project – A Mechanism for Data Sharing. N Engl J Med. 2016;375:403-5.
17. Powell-Smith A, Goldacre B. The TrialsTracker: Automated ongoing monitoring of failure to share clinical trial results by all major companies and research institutions. F1000Research. 2016;5:2629.
18. Hol D. ‘We’ve been deceived’: Many clinical trial results are never published [Internet]. CBC News, Canada; 2016 Nov 24. Available from: http://www. cbc.ca/news/health/clinical-trial-results-not-published-1.3865785
19. Goldacre B. How to Get All Trials Reported: Audit, Better Data, and Individual Accountability. PLOS Medicine. 2015;12(4):e1001821.
20. Ghersi D, Clarke M, Berlin J, et al. Reporting the findings of clinical trials: a discussion paper [Internet]. Bulletin of the World Health Organization. 2008;86(6):417-96.
21. AllTrials [Internet]. London, UK. 2013 Sept. Available from: http://www.all- trials.net/find-out-more/all-trials/
22. Lane, S. AllTrials campaign and petition support greater clinical trial transparency. [Internet] Elsevier. 2014 June 23. Available from: https://www. elsevier.com/connect/alltrials-campaign-supports-greater-clinical-trial- transparency
23. Thomas K, Schmidt MS. Glaxo Agrees to Pay $3 Billion in Fraud Settlement. [Internet] The New York Times. 2012 July 2. Available from: http://www.nytimes.com/2012/07/03/business/glaxosmithkline-agrees-to-pay-3-billion- in-fraud-settlement.html
24. Tucker K, Branson J, Dilleen M, et al. Protecting patient privacy when sharing patient-level data from clinical trials. BMC Med Res Methodol. 2016;16(1):77.
25. Price WN, Minssen T. Will clinical trial data disclosure reduce incentives to develop new uses of drugs? Nat Publ Gr. 2015;33(7):685-6.
26. Roin BN. Solving the problem of new uses [Internet]. Social Science Research Network. 2013 October 10. Available from: http:// dx.doi.org/10.2139/ ssrn.2337821