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Table of Contents: July 2008

COVER

With FDAAA the Train Leaves the Station: Reporting Clinical Trial Results.

Image Credit: Image by dbking at flickr.com
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"With FDAAA the train leaves the station," says this month's editorial, which discusses the requirements of the 2007 Food and Drug Administration Amendments Act for the reporting of clinical trials results. Effective September 2008, a provision of this US law requires that the enrollment and outcome data from trials of drugs, biologics, and devices (excluding phase I trials) must appear in an open repository, generally within a year of the trial's completion, whether the results are published or not. But in making these outcomes available the law poses new questions for medical journals, whose editors must assess how much data can be presented publicly without constituting prior publication.

Editorial

Health in Action

Policy Forum

Guidelines and Guidance

Immunological Outcomes of New Tuberculosis Vaccine Trials: WHO Panel Recommendations

Willem A Hanekom, Hazel M Dockrell, Tom H. M Ottenhoff, T. Mark Doherty, Helen Fletcher, Helen McShane, Frank F Weichold, Dan F Hoft, Shreemanta K Parida, Uli J Fruth

Scaling Up Programmatic Management of Drug-Resistant Tuberculosis: A Prioritized Research Agenda

Frank G. J Cobelens, Einar Heldal, Michael E Kimerling, Carole D Mitnick, Laura J Podewils, Rajeswari Ramachandran, Hans L Rieder, Karin Weyer, Matteo Zignol , on behalf of the Working Group on MDR-TB of the Stop TB Partnership

Research in Translation

Evidence-Based Tuberculosis Diagnosis

Madhukar Pai, Andrew Ramsay, Richard O'Brien

Learning Forum

A 58-Year-Old Woman with Abdominal Symptoms and Elevated C-Reactive Protein

Marie-Louise Daly, David J Cartwright, Paul J Lehner, Babak Javid

Research Articles

Toward a Global View of Alcohol, Tobacco, Cannabis, and Cocaine Use: Findings from the WHO World Mental Health Surveys

Louisa Degenhardt, Wai-Tat Chiu, Nancy Sampson, Ronald C Kessler, James C Anthony, Matthias Angermeyer, Ronny Bruffaerts, Giovanni de Girolamo, Oye Gureje, Yueqin Huang, Aimee Karam, Stanislav Kostyuchenko, Jean Pierre Lepine, Maria Elena Medina Mora, Yehuda Neumark, J. Hans Ormel, Alejandra Pinto-Meza, José Posada-Villa, Dan J Stein, Tadashi Takeshima, J. Elisabeth Wells

Public-Health and Individual Approaches to Antiretroviral Therapy: Township South Africa and Switzerland Compared

Olivia Keiser, Catherine Orrell, Matthias Egger, Robin Wood, Martin W. G Brinkhof, Hansjakob Furrer, Gilles van Cutsem, Bruno Ledergerber, Andrew Boulle , for the Swiss HIV Cohort Study (SHCS) and the International Epidemiologic Databases to Evaluate AIDS in Southern Africa (IeDEA-SA)

Minority HIV-1 Drug Resistance Mutations Are Present in Antiretroviral Treatment–Naïve Populations and Associate with Reduced Treatment Efficacy

Jeffrey A Johnson, Jin-Fen Li, Xierong Wei, Jonathan Lipscomb, David Irlbeck, Charles Craig, Amanda Smith, Diane E Bennett, Michael Monsour, Paul Sandstrom, E. Randall Lanier, Walid Heneine

The Effect of Delaying Childbirth on Primary Cesarean Section Rates

Gordon C. S Smith, Yolande Cordeaux, Ian R White, Dharmintra Pasupathy, Hannah Missfelder-Lobos, Jill P Pell, D. Stephen Charnock-Jones, Michael Fleming

Neonatal Thyroid Function in Seveso 25 Years after Maternal Exposure to Dioxin

Andrea Baccarelli, Sara M Giacomini, Carlo Corbetta, Maria Teresa Landi, Matteo Bonzini, Dario Consonni, Paolo Grillo, Donald G Patterson Jr., Angela C Pesatori, Pier Alberto Bertazzi

The Spectrum of Intermediate Syndrome Following Acute Organophosphate Poisoning: A Prospective Cohort Study from Sri Lanka

Pradeepa Jayawardane, Andrew H Dawson, Vajira Weerasinghe, Lakshman Karalliedde, Nicholas A Buckley, Nimal Senanayake

Incidence and Clinical Characteristics of Group A Rotavirus Infections among Children Admitted to Hospital in Kilifi, Kenya

D. James Nokes, John Abwao, Allan Pamba, Ina Peenze, John Dewar, J. Kamino Maghenda, Hellen Gatakaa, Evasius Bauni, J. Anthony G Scott, Kathryn Maitland, Thomas N Williams

Correction

Correction: Characterizing the Epidemiological Transition in Mexico: National and Subnational Burden of Diseases, Injuries, and Risk Factors

Gretchen Stevens, Rodrigo H Dias, Kevin J. A Thomas, Juan A Rivera, Natalie Carvalho, Simón Barquera, Kenneth Hill, Majid Ezzati