The BMJ requires data sharing to publish clinical trials

Adapted photo from the original: r. nial bradshaw.

The reproducibility, reliability and transparency of clinical trials depend, among other factors, on its wide spread via registration on platforms created for this purpose, as well as the publication in scientific journals. The main objective of these measures is to prevent parts to fail to disclose negative or undesirable effects of new drugs, equipment or medical procedures.

In a post recently published¹ in this blog, it was reported that less than half of clinical trials registered in the ClinicalTrials.gov platform were published after five years of their completion. And let’s not just blame the pharmaceutical industry; academic institutions and government research agencies, as the National Institutes of Health (NIH), have even lower publication rates. In this sense, the AllTrials initiative, created by the British agency Sense About Science, was created to encourage and compel researchers to publish all clinical trials they perform.

The relevance of this measure is reflected in the recent decision of the prestigious journal “The BMJ” (originally British Medical Journal), the first journal to only consider for publication clinical trials whose authors agrees to provide anonymously, on reasonable request, the individual data from each participating patient. The editorial that communicates this decision², signed by Elizabeth Loder, acting head of research and Trish Groves, deputy editor and editor in chief of BMJ Open, states “The movement to make data from clinical trials widely accessible has achieved enormous success, and it is now time for medical journals to play their part. From 1 July, The BMJ will extend its requirements for data sharing to apply to all submitted clinical trials, not just those that test drugs or devices.” The journal had already pioneered the request since 2013 of patient data sharing of clinical trials related to new drugs and equipment.

This policy meets the statements of the World Health Organization (WHO) and the Nordic Trial Alliance, to encourage transparency of clinical trial results. All data of the participants and the results should be made publicly available and submitted for publication in scientific journals within one year from their completion.

The open availability of research results in general is part of the Open Data movement, which main objective is to increase transparency, reproducibility, availability and interoperability of basic research data. In recent years, research institutions, research funding agencies, the private sector, governments and the civil society are debating the most effective ways to operationalize repositories capable of storing the data in machine readable format, and great progress has been made since.

Loder believes that “Making anonymized patient level data from clinical trials available for independent scrutiny allows other researchers to replicate key analyses, reduces the possibility that studies will be unnecessarily duplicated, and maximizes use of the information from trials—an important moral obligation to trial participants”.

As the Open Data movement, clinical trials data sharing will require initial investment of human and financial resources to prepare the data for storage. Over time, however, the data value should increase with the shared use for the benefit of all.

Notes

1. SCIENTIFIC ELECTRONIC LIBRARY ONLINE. Unpublished results from clinical trials distort medical research. SciELO in Perspective. [viewed 24 August 2015]. Available from: http://blog.scielo.org/en/2015/08/12/unpublished-results-from-clinical-trials-distort-medical-research/

2. LODER, E.; GROVES, E. The BMJ requires data sharing on request for all trials. BJM. 2015, vol. 350, pp. 1-2. DOI: 10.1136/bmj.h2373

References

LODER, E.; GROVES, E. The BMJ requires data sharing on request for all trials. BJM. 2015, vol. 350, pp. 1-2. DOI: 10.1136/bmj.h2373

Report on transparency and registration in clinical research in the Nordic Countries. Nordic Trial Alliance Working Group. 2015. Available from: http://nta.nordforsk.org/projects/FINALNTAWPG30032015.pdf.

SCIENTIFIC ELECTRONIC LIBRARY ONLINE. The Open Data movement: international consolidation. SciELO in Perspective. [viewed 24 August 2015]. Available from: http://blog.scielo.org/en/2014/07/14/the-open-data-movement-international-consolidation/

SCIENTIFIC ELECTRONIC LIBRARY ONLINE. Unpublished results from clinical trials distort medical research. SciELO in Perspective. [viewed 24 August 2015]. Available from: http://blog.scielo.org/en/2015/08/12/unpublished-results-from-clinical-trials-distort-medical-research/

WHO statement on public disclosure of clinical trial results. World health Organization. 2015. Available from: http://www.who.int/ictrp/results/reporting/en/

External link

AllTrials – <http://www.alltrials.net/>

About Lilian Nassi-Calò

Lilian Nassi-Calò studied chemistry at Instituto de Química – USP, holds a doctorate in Biochemistry by the same institution and a post-doctorate as an Alexander von Humboldt fellow in Wuerzburg, Germany. After her studies, she was a professor and researcher at IQ-USP. She also worked as an industrial chemist and presently she is Coordinator of Scientific Communication at BIREME/PAHO/WHO and a collaborator of SciELO.

Translated from the original in portuguese by Lilian Nassi-Calò.