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Indian Pediatr 2017;54: 790 |
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Clinical Trials: A Step Closer to Universal
Data Sharing
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* Shahid Akhtar Siddiqui and
Anubha Shrivastava
Department of Pediatrics, SN Children Hospital, MLN
Medical College, Allahabad, UP, India.
Email: [email protected]
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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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