Key regulatory issues for dengue vaccine development

February 22, 2011

In this week's PLoS Medicine, Richard Mahoney and colleagues discuss two recent meetings convened by the Pediatric Dengue Vaccine Initiative and the Developing Countries' Vaccine Regulators Network on regulatory issues that need to be addressed before licensing dengue vaccines.

Funding: This work was supported by Bill & Melinda Gates Foundation grant# 23197. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

Competing Interests: The authors have declared that no competing interests exist.

Citation: Mahoney R, Chocarro L, Southern J, Francis DP, Vose J, et al. (2011) Dengue Vaccines Regulatory Pathways: A Report on Two Meetings with Regulators of Developing Countries. PLoS Med 8(2): e1000418.doi:10.1371/journal.pmed.1000418

IN YOUR COVERAGE PLEASE USE THIS URL TO PROVIDE ACCESS TO THE FREELY AVAILABLE PAPER: http://www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.1000418

CONTACT:

rmahoney@ivi.int




PLoS Medicine announces support for registration of systematic reviews

Systematic reviews (overviews of healthcare interventions that use predefined methods to find and appraise all the relevant evidence) are generally considered to provide reliable evidence for decision-making in clinical practice, if carefully carried out and transparently reported. However, there is potential for bias in the conduct and reporting of systematic reviews through nonpublication of "negative" outcomes. Given this potential for bias, PLoS Medicine announces its support for an initiative which will enable prospective registration of systematic reviews during the planning stage. The PROSPERO registry (http://www.crd.york.ac.uk/PROSPERO)

provides a free mechanism for systematic reviewers around the world to record their planned or ongoing systematic review. PLoS Medicine will now ask authors who submit reports of systematic reviews whether they registered their study, and will ask authors to provide a copy of the systematic review protocol if available. Other PLoS journals publishing systematic reviews will also follow this approach. The editors hope these steps will encourage and enable more transparent reporting of systematic reviews.

Funding: The authors are each paid a salary by the Public Library of Science, and they wrote this editorial during their salaried time.

Competing Interests: The authors' individual competing interests are at http://www.plosmedicine.org/static/editorsInterests.action. PLoS is funded partly through manuscript publication charges, but the PLoS Medicine Editors are paid a fixed salary (their salary is not linked to the number of papers published in the journal).

Citation: The PLoS Medicine Editors (2011) Best Practice in Systematic Reviews: The Importance of Protocols and Registration. PLoS Med 8(2): e1001009. doi:10.1371/journal.pmed.1001009

IN YOUR COVERAGE PLEASE USE THIS URL TO PROVIDE ACCESS TO THE FREELY AVAILABLE PAPER: http://www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.1001009

CONTACT:

Medicine_editors@plos.org

press@plos.org
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