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Correspondence

Indian Pediatr 2017;54: 790

Clinical Trials: A Step Closer to Universal Data Sharing

 

*Shahid Akhtar Siddiqui and Anubha Shrivastava

Department of Pediatrics, SN Children Hospital, MLN Medical College, Allahabad, UP, India.
Email: [email protected]

 


The International Committee of Medical Journal Editors (ICMJE) requires registration of clinical trials in a public trials registry at or before enrolment of first participant as a condition to be considered for publication [1]. All clinical trials should be prospectively registered in one of six primary registries recommended by World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP).

Conducting trials is a tedious task as it consumes time, manpower and finances. Participants are exposed to intervention risks. To minimize research duplication in a specific setting, it is necessary to share results and trial data avoiding individual participant identification. To fulfil these aims, ICMJE has mandated that from July 1, 2018, manuscripts of results of clinical trials must have a data sharing statement and trials enrolling first participant from January 1, 2019 must have a data sharing plan [2].

As trial participants expose themselves to potential risks, it is ethical obligation of medical fraternity to maintain confidentiality of patient information. On the other hand, we are heading towards a future where all patient data is shared and easily available to researchers. A practical way to maximize benefits and exclude misuse of data is to be urgently worked out.

References

1. International Committee of Medical Journal Editors. Available from: http://www.icmje.org/recommendations/browse/publishing-and-editorial-issues/clinical-trial-registration.html. Accessed July 2, 2017.

2. Taichman DB, Sahni P, Pinborg A, Peiperl L, Laine C, James A, et al. Data sharing statements for clinical trials: A requirement of the International Committee of Medical Journal Editors. JAMA. 2017;317:2491-2.


 

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