The International Journal of Tuberculosis and Lung Disease has released its May publication featuring RESIST-TB Steering Committee members Dr. C. Robert Horsburgh and Dr. Carole Mitnick as guest editors. The issue also features articles written by a number of RESIST-TB members and partners. Please see a full list of articles below:
Has compassionate use ever sunk a drug? Mcanaw S, Muller A, Mitnick C, Horsburg C.R
Community engagement for paediatric MDR-TB clinical trials: principles to support ethical trial implementation
Hoddinott G, Staples S, Brown R, Simwinga M, Mubekapi-Musadaidzwa C, Hesseling AC, Hendricks G, De Koker P, McKenna L
Conducting efficacy trials in children with MDR-TB: what is the rationale and how should they be done?
Seddon JA, Weld ED, Schaaf HS, Garcia-Prats AJ, Kim S, Hesseling AC
Statistical considerations for pediatric multidrug-resistant tuberculosis efficacy trials
Kim S, Seddon JA, Garcia-Prats AJ, Montepiedra G
Current status of pharmacokinetic and safety studies of multidrug-resistant tuberculosis treatment in children
Garcia-Prats AJ, Svensson EM, Weld ED, Schaaf HS, Hesseling AC
Preclinical tools for the evaluation of tuberculosis treatment regimens for children
Tucker EW, Dooley KE
The burden of multidrug-resistant tuberculosis in children
Jenkins HE, Yuen CM
MDR-TB in children: back to the basics
Horsburgh CR, Gupta A
Annual Report (2017) Our Annual Report details the progress that each working group made in 2017, as well as sets goals for 2018.
RESIST-TB Site Development Report and Site Development Tool (2017) The Site Development Report outlines efforts to expand the number of possible MDR-TB clinical trial sites in areas with access to patients and interest in becoming trial sites. RESIST-TB developed a Site Development Tool to determine whether those sites either had adequate capacity or needed site development activity.
Annual Report (2016) Our Annual Report details the progress that each working group made in 2016, as well as sets goals for 2017.
Programmatic Management of Drug-Resistant Tuberculosis: An Updated Research Agenda (2016) There are numerous challenges in delivering appropriate treatment for multidrug-resistant tuberculosis (MDR-TB) and the evidence base to guide those practices remains limited. This piece presents the third updated Research Agenda for the programmatic management of drug-resistant TB (PMDT), assembled through a literature review and survey.
Global MDR-TB Clinical Trials Landscape Meeting Supplement (2016) Based on the results of the first global MDR-TB Clinical Trials Landscape meeting held in 2014, this supplement includes a collection of manuscripts that address key topics including both methodological issues and agent-specific reports. These articles provide an in-depth discussion of the rationale behind current MDR-TB clinical trials as well as important insights to drive future research.
Monitoring Compassionate Use of New Drugs for Tuberculosis (2016) With support from the Firland Foundation, RESIST-TB investigated mechanisms for accessing drugs prior to regulatory approval and surveyed key providers and advocates on their experience attempting to gain access to new TB drugs through compassionate use or similar pre-approval mechanisms. The findings from this project are detailed in this report, “Monitoring Compassionate Use of New Drugs for Tuberculosis.
Drug-Resistant Tuberculosis Clinical Trials: Proposed Core Research Definitions in Adults (2016) Presents a core set of efficacy and safety definitions as well as other important considerations in DR-TB clinical trials work.
Clinical Implications of Molecular Drug Resistance Testing for Mycobacterium Tuberculosis: A TBNET/RESIST-TB Consensus Statement (2016) Proposes that reports of molecular DST results should include information on specific mutations that affect resistance to chose an appropriate treatment regimen.
Programmatic Management of Drug-Resistant Tuberculosis: An Updated Research Agenda (2016) Identifies priorities for coordinated research in PMDT that could fill longstanding gaps barring expanded treatment access, including: shorter treatment regimens, knowledge of disease burden without representative data, and treatment for latent TB infection in household contacts of known DR-TB patients.
Annual Report (2015) Our Annual Report details the progress that each working group made in 2015, as well as sets goals for 2016.
Issues in Design and Interpretation of MDR-TB Clinical Trials: Report of the First Global MDR-TB Clinical Trials Landscape Meeting (2015) Outlines meetings held in Washington D.C. and Cape Town, South Africa which discussed clinical trial design and new and existing treatment regimens for MDR-TB.
RESIST-TB 2015 Strategic Goals and Objectives (2015) Reflects our greater goals to be accomplished by 2020
Annual Report (2014) Our Annual Report details the progress that each working group made in 2014, as well as sets goals for 2015.
Annual Report (2013) Our Annual Report details the progress that each working group has made in 2013, as well as sets goals 2014.
WHO Group 5 Drugs for the Treatment of Drug-Resistant Tuberculosis- Unclear Efficacy or Untapped Potential? (2013) Journal of Infectious Diseases 2013:207.
Annual Report (2012) Our Annual Report details the progress that each working group has made in 2012, as well as sets goals for 2013.
Statement to the FDA (2012) Statement to the FDA supporting the approval of bedaquiline
Compassionate use of and expanded access to new drugs for drug-resistant tuberculosis. (2012) International Journal of Tuberculosis and Lung Disease 17(2) 146-152 (2012).
Old Drugs, New Purpose- Retooling Existing Drugs for Optimized Treatment of Resistant Tuberculosis (2012) Clinical Infectious Diseases 2012:55.
Annual Report (2011) Our Annual Report details the progress that each working group has made in 2011, as well as sets goals for 2012.
RESIST-TB Response to RFI (NOT-AI-10-015) (2010) Proposes that the NIH clinical trial networks focus on studies that will expeditiously lead to improved treatment regimens for MDR-TB
Plan for MDR-TB Clinical Trials: An Overview (2010) Plan for the design and implementation of new trials in DR-TB
Research Priorities for New and Existing Drugs in MDR-TB Clinical Trials: A report of the TBTC MDR/XDR-TB Working Group and RESIST-TB (2010) Outlines the major areas of MDR-TB research interest
Testimony to the FDA Anti-Infective Drugs Advisory Committee (2009) Presentation to the FDA on the urgency for accelerated approval of new MDR-TB indications
Report on the RESIST-TB Protocol Workshop (Amsterdam, 2009) Outlines MDR-TB clinical trial designs
Scaling Up Programmatic Management of Drug-Resistant Tuberculosis: A Prioritized Research Agenda (2008) Research agenda developed by the Stop TB Partnership that identifies the most important barriers to scale-up of programmatic management of MDR-TB in resource-limited settings, and prioritizes research questions to be addressed in order to overcome highlighted barriers.
Rainbow Document (2008) The Rainbow Document is a white paper reviewing the obstacles to the development of clinical trials for DR-TB and presenting an initial plan for overcoming these obstacles. It was written as a response to a brainstorming session on DR-TB clinical trials organized by the Research Subgroup of the MDR-TB Working Group and the IUATLD Clinical Trial Division in Cape Town, South Africa, in November 2007.
Cambridge Declaration (2008) The Cambridge Declaration is a statement advocating for clinical trials on drug-resistant tuberculosis, drafted and signed at the Workshop on Clinical Trials for Treatment of Drug-Resistant TB, held in Cambridge, MA, USA, in June 2008.