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PFG

Articles on Clinical Trials

General

     •     Protecting clinical trial participants and protecting data integrity: Are we meeting the challenges?  Ellenberg S. PLoS Med. 12 June 2012

     •     Clinical trials have gone global: Is this a good thing? Lang T & Siribaddana S. PLoS Med. 12 June 2012; 9(6)

     •     More Efficient Ways of Assessing Treatments for Neglected Tropical Diseases Are Required: Innovative Study Designs, New Endpoints, and Markers of Effects. Olliaro P et al. PLoS Negl Trop Dis 6(5): e1545

     •     Safer, Faster, Cheaper: Improving Clinical Trials and Regulatory Pathways to Fight Neglected Diseases. Center for Global Development. October 31 2011.

     •     Clinical research: time for sensible global guidelines. Lang T et al. The Lancet, Early Online Publication, 21 February 2011

     •     U.S. Bioethics Panel to Review Clinical Trials Around the World. Kaiser J. ScienceInsider.  March 1, 2011.

     •     Predicting Harms and Benefits in Translational Trials: Ethics, Evidence, and Uncertainty. Kimmelman J & London AJ. PLoS Med 8(3): e1001010. doi:10.1371/journal.pmed.1001010

     •     How can institutional review boards best interpret preclinical data? Lavery J. PLoS Med 8(3): e1001011. doi:10.1371/journal.pmed.1001011

     •     New FDA Regulation to Improve Safety Reporting in Clinical Trials. Sherman RB et al. NEJM. June 8, 2011 (10.1056/NEJMp1103464) Strengthening the informed consent process in international health research through community engagement: the KEMRI-Wellcome trust Research Programme experience.  Bog M et al. PLoS Medicine. 13 September 2011; 8(9)

     •     African Networks launch to boost clinical trial capacity.  Nature Medicine.  16 (1):8.  January 2010. nm0110-8a.pdf

     •     Communications Handbook for Clinical Trials.  Robinson ET et al. Microbicides Media and Communications Initiative. May 2010.

     •     How ethical is your clinical trial? Miller L, Folayan M, Allman D, Nkala B, et al. International Journal of Clinical Practice. 16 June 2010

     •     Developing ethics guidance for HIV prevention research: the HIV Prevention Trials Network approach. Rennie S and Sugarman J. Journal of Medical Ethics. 1 December 2010; 36(12):810-815

     •     FDA, European Medicines Agency Launch Good Clinical Practices Initiative Collaborative effort aims to ensure appropriate conduct of clinical trials.  August 2009

     •     WHO provides primary status to the Pan African Clinical Trials Registry in Africa.  September 2009

     •     EDCTP: a genuine north–south partnership. Mgone & Salami.  Tropical Medicine and International Health.  14 (11):  1327-1328

     •     Workshop on Clinical Trials Capacity in Low- and Middle-Income Countries: Experiences, Lessons Learned and Priorities for Strengthening. IPPH. 2002.


HIV related

     •     'It looks like you just want them when things get rough': Civil society perspectives on negative trial results and stakeholder engagement in HIV prevention trials. Koen J et al. Developing World Bioethics. 25 January 2013:1471-8847.

     •     Microbicide clinical trial adherence: Insights for introduction. Woodsong C et al. J Intl AIDS Society. 8 April 2013

     •     Ethical considerations in determining standard of prevention packages for HIV prevention trials: Examining PrEP. Haire B et al. Article first published online: 31 May 2013. DOI: 10.1111/dewb.12032

     •     Future of PrEP and Microbicide Research: Trial Design and Regulatory Issues.   Forum for Collaborative HIV Research. Materials from a meeting held January 7, 2013.

     •     The Community Advisory Board—An Evolving Approach to Community Engagement. IAVI Insights.  March 2012

     •     Guidance Tool For Community Advisory Boards. IAVI. March 2012

     •     Clinical guidance: Essential approaches for the conduct of IAVI Clinical Research. IAVI. April 2012

     •     Improving participant understanding of informed consent in an HIV-prevention clinical trial: A comparison of methods. Corneli AL et al. AIDS and Behavior. 1 February 2012; 16(2):412-421.

     •     Design challenges facing clinical trials of the effectiveness of new HIV prevention technologies. Grobler AC et al. AIDS. 31 March 2012

     •     Good Participatory Practice (GPP): Guidelines for biomedical HIV prevention trials.  UNAIDS & AVAC.  Second Edition.  June 2011.

     •     "Once bitten, twice shy": participant perspectives in the aftermath of an early HIV vaccine trial termination. Newman PA, Yim S, Daley A, Walisser R, et al. Vaccine. 10 January 2011; 29(3):451-458.

     •     Strategies to retain participants in a long-term HIV prevention randomized controlled trial: lessons from the MINTS-II study. Horvath KJ et al. AIDS and Behavior. 3 May 2011

     •     Fostering community understanding of sufficient benefit and early stopping for a phase 2B HIV prevention clinical trial in Africa. White R et al. Clinical Trials. 18 February 2011; 8(1):103-111.

     •     Evaluation of large-scale combination HIV prevention programs: essential issues. Padian NS et al. JAIDS Journal of Acquired Immune Deficiency Syndromes. Published online: 18 June 2011

     •     Intertwining biomedical research and public health in HIV microbicide research.  Macklin R. Public Health Ethics (2010) 3 (3): 199-209.

     •     Ethics, human rights and HIV vaccine trials in low-income settings. London L et al. Journal of Medical Ethics. 6 December 2011

     •     The Journey Toward an AIDS Vaccine: Perspectives on Conducting Trials in Developing Countries.  IAVI.  Policy Research Working Paper 16.  2007.


TB related

     •     Lessons learnt from the first efficacy trial of a new infant tuberculosis vaccine since BCG. Tameris M et al. Tuberculosis. Published online 13 February 2013.

     •     Assessment of global capacity to conduct tuberculosis drug development trials: do we have what it takes? Niekerk & Ginsberg.  Int J Tuberc Lung Dis 13(11):1367-1372

     •     Tuberculosis case-contact research in endemic tropical settings: design, conduct, and relevance to other infectious diseases. Hill PC & Ota MOC. The Lancet Infectious Diseases, Volume 10, Issue 10, Pages 723 - 732, October 2010