Promoting data sharing in clinical trials to improve the transparency of clinical trials_Chinese Journal of Evidence-Based Medicine

Authors：

LAM Wai Ching ¹ , TIAN Ran ¹ , ZHAO Chen ¹ , SHANG Hongcai ² , WU Taixiang ³ , LI Youping ³ ,  BIAN Zhaoxiang ¹

1. School of Chinese Medicine, Hong Kong Baptist University, Hongkong, 999077, P.R.China;
2. Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, 100700, P.R.China;
3. Chinese Evidence-based Medicine Center, West China Hospital, Sichuan University, Chengdu, 610041, P.R.China;

Corresponding author：

BIAN Zhaoxiang, Email: bianzxiang@gmail.com

Keywords：

Clinical trial; Data sharing; Transparency; Authenticity of clinical trial

DOI：

10.7507/1672-2531.201801065

Video：

Export PDF Favorites Scan Get Citation

Abstract Full text Figures/Tables Video References Cited by

Sharing clinical trial data can increase the transparency of clinical trials and improve the its authenticity. The current requirements of clinical research data transparency is not fully adequate, and it is still difficult to create an environment in which the sharing of the clinical trial data becomes the norm. The article analyzed various concerns on data sharing and proposed solutions in data ownership, technology, implementation, and legal issues systematically, calling for clinical trial data sharing in order to promote transparency of clinical trials, and looking forward to minimize the risks and maximize the benefits of data sharing.

Citation： LAM Wai Ching, TIAN Ran, ZHAO Chen, SHANG Hongcai, WU Taixiang, LI Youping, BIAN Zhaoxiang. Promoting data sharing in clinical trials to improve the transparency of clinical trials. Chinese Journal of Evidence-Based Medicine, 2018, 18(9): 893-895. doi: 10.7507/1672-2531.201801065 Copy

1.	Vickers AJ. Whose data set is it anyway? Sharing raw data from randomized trials. Trials, 2006, 16, 7: 15.
2.	Food and Drug Administration Amendments Act of 2007. Available at: https://www.fda.gov/RegulatoryInformation/LawsEnforcedbyFDA/SignificantAmendmentstotheFDCAct/FoodandDrugAdministrationAmendmentsActof2007/ucm095442.
3.	World Health Organization (WHO). WHO statement on public disclosure of clinical trial results. Geneva: WHO, 2015. Available at: http://www.who.int/ictrp/results/WHO_Statement_results_reporting_clinical_trials.pdf.
4.	China Food and Drug Administration (CFDA). Announcements about clinical trial data self- inspection and verification. 2015. http://www.sda.gov.cn/WS01/CL1278/124800.html.
5.	European Medicines Agency (EMA). Opening up clinical data on new medicines. Available at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2016/10/news_detail_002624.jsp&mid=WC0b01ac058004d5c1.
6.	Taichman D B, Sahni P, Pinborg A, et al. Data sharing statements for clinical trials. BMJ, 2017, 357: j2372.
7.	Research Councils UK (RCUK). Common principles on data policy. Available at: http://www.rcuk.ac.uk/research/datapolicy/.
8.	Public Library of Science (PLOS). Data availability. Available at: http://journals.plos.org/plosmedicine/s/data-availability#locacceptable-data-sharing-methods.
9.	Loder E, Groves T. The BMJ requires data sharing on request for all trials. BMJ, 2015, 350: h2373.
10.	Medical Research Council (MRC). Policies and guidance for researchers. Available at: https://www.mrc.ac.uk/research/policies-and-guidance-for-researchers/.
11.	Institute of Medicine (IOM). Discussion framework for clinical trial data sharing: guiding principles, elements, and activities. Available at: https://www.nap.edu/catalog/18610/discussion-framework-for-clinical-trial-data-sharing-guiding-principles-elements.
12.	Bian ZX, Wu TX. Legislation for trial registration and data transparency. Trials, 2010, 11(1): 64.
13.	Song F, Parekh S, Hooper L, et al. Dissemination and publication of research findings: an updated review of related biases. Health Technol Assess, 2010, 14(8): 1-193.
14.	Dowsett SA, Van Campen LE, Bednar LA. Developing good scientific publishing practices: one pharmaceutical company's perspective. Curr Med Res Opin, 2010, 26(6): 1249-1254.
15.	Beach JE. Clinical trials integrity: a CRO perspective. Account Res, 2001, 8(3): 245-260.
16.	The University of Utah. Ownership, intellectual property, and governance considerations for academic research data. Available at: https://www.slideshare.net/RebekahCummings/ownership-intellectual-property-and-governance-considerations-for-academic-research-data.
17.	Suvarna V. Investigator initiated trials (IITs). Perspect Clin Res, 2012, 3(4): 119-121.
18.	Terry SF, Terry PF. Power to the people: participant ownership of clinical trial data. Sci Transl Med, 2011, 3(69): 69cm3.
19.	Haug CJ. Whose data are they anyway? Can a patient perspective advance the data-sharing debate? N Engl J Med, 2017, 376(23): 2203.

1. Vickers AJ. Whose data set is it anyway? Sharing raw data from randomized trials. Trials, 2006, 16, 7: 15.
2. Food and Drug Administration Amendments Act of 2007. Available at: https://www.fda.gov/RegulatoryInformation/LawsEnforcedbyFDA/SignificantAmendmentstotheFDCAct/FoodandDrugAdministrationAmendmentsActof2007/ucm095442.
3. World Health Organization (WHO). WHO statement on public disclosure of clinical trial results. Geneva: WHO, 2015. Available at: http://www.who.int/ictrp/results/WHO_Statement_results_reporting_clinical_trials.pdf.
4. China Food and Drug Administration (CFDA). Announcements about clinical trial data self- inspection and verification. 2015. http://www.sda.gov.cn/WS01/CL1278/124800.html.
5. European Medicines Agency (EMA). Opening up clinical data on new medicines. Available at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2016/10/news_detail_002624.jsp&mid=WC0b01ac058004d5c1.
6. Taichman D B, Sahni P, Pinborg A, et al. Data sharing statements for clinical trials. BMJ, 2017, 357: j2372.
7. Research Councils UK (RCUK). Common principles on data policy. Available at: http://www.rcuk.ac.uk/research/datapolicy/.
8. Public Library of Science (PLOS). Data availability. Available at: http://journals.plos.org/plosmedicine/s/data-availability#locacceptable-data-sharing-methods.
9. Loder E, Groves T. The BMJ requires data sharing on request for all trials. BMJ, 2015, 350: h2373.
10. Medical Research Council (MRC). Policies and guidance for researchers. Available at: https://www.mrc.ac.uk/research/policies-and-guidance-for-researchers/.
11. Institute of Medicine (IOM). Discussion framework for clinical trial data sharing: guiding principles, elements, and activities. Available at: https://www.nap.edu/catalog/18610/discussion-framework-for-clinical-trial-data-sharing-guiding-principles-elements.
12. Bian ZX, Wu TX. Legislation for trial registration and data transparency. Trials, 2010, 11(1): 64.
13. Song F, Parekh S, Hooper L, et al. Dissemination and publication of research findings: an updated review of related biases. Health Technol Assess, 2010, 14(8): 1-193.
14. Dowsett SA, Van Campen LE, Bednar LA. Developing good scientific publishing practices: one pharmaceutical company's perspective. Curr Med Res Opin, 2010, 26(6): 1249-1254.
15. Beach JE. Clinical trials integrity: a CRO perspective. Account Res, 2001, 8(3): 245-260.
16. The University of Utah. Ownership, intellectual property, and governance considerations for academic research data. Available at: https://www.slideshare.net/RebekahCummings/ownership-intellectual-property-and-governance-considerations-for-academic-research-data.
17. Suvarna V. Investigator initiated trials (IITs). Perspect Clin Res, 2012, 3(4): 119-121.
18. Terry SF, Terry PF. Power to the people: participant ownership of clinical trial data. Sci Transl Med, 2011, 3(69): 69cm3.
19. Haug CJ. Whose data are they anyway? Can a patient perspective advance the data-sharing debate? N Engl J Med, 2017, 376(23): 2203.

Chinese Journal of Evidence-Based Medicine

Promoting data sharing in clinical trials to improve the transparency of clinical trials

Abstract Full text Figures/Tables Video References Cited by

Previous Article

Next Article

Format

Content