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Please use this identifier to cite or link to this item: http://hdl.handle.net/10713/8275

Title: Challenges of independent assessment of potential harms of HPV vaccines
Doshi_ChallengesOfIndependentAssessmentOfHPVVaccines_2018.pdf  (1.28 MB)  
External Resource/s: Click here for the free full-text article on publisher’s website
Authors: Doshi, Peter
Date: 2018-09-24
Publisher: BMJ Publishing Group
Citation: Doshi, P. (2018). Challenges of independent assessment of potential harms of HPV vaccines. BMJ, 362:k3694. doi: https://doi.org/10.1136/bmj.k3694
Subject Keywords: clinical study reports
clinical 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
Description: 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
Peer Reviewed: Yes
Type: Article
Appears in Collections:Dr. Peter Doshi

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