Challenges of independent assessment of potential harms of HPV vaccines
Date
2018-09-24Publisher
BMJ Publishing GroupPeer Reviewed
YesType
Article
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Key messages:• Public confidence in interventions such as vaccines relies on comprehensive, independent, and accurate assessments;
• Clinical study reports contain more information than journal publications but are harder to access;
• Only half of potentially eligible reports for a systematic review of HPV vaccines had been obtained after three years, and these were incomplete and contained redactions;
• Regulators did not have the full data and the manufacturers place restrictions on the dissemination of data;
• The process for releasing clinical study reports should be improved to make it faster and more complete
Citation
Doshi, P. (2018). Challenges of independent assessment of potential harms of HPV vaccines. BMJ, 362:k3694. doi: https://doi.org/10.1136/bmj.k3694Keyword
clinical study reportsclinical trial data
Cervarix
research transparency
Gardasil
European Medicines Agency
GlaxoSmithKline
Merck Sharp & Dohme
Access to Information
Complex Regional Pain Syndromes
Papillomavirus Vaccines
Papillomavirus Vaccines--adverse effects
Postural Orthostatic Tachycardia Syndrome
Identifier to cite or link to this item
http://hdl.handle.net/10713/8275ae974a485f413a2113503eed53cd6c53
10.1136/bmj.k3694
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- Creative Commons
Except where otherwise noted, this item's license is described as https://creativecommons.org/licenses/by-nc-nd/4.0/