TRAINING IN CLINICALRESEARCH RELEVANT TO INTERNATIONAL TRANSFUSION SAFETY Africa Society for Blood Transfusion (AfSBT) Mauritius 4 th -7 th June 2012
Background Research in epidemiology, virology, and immunology is important to improve blood safety in low and middle income countries. Research limited by a lack of trained clinical research personnel The number of candidates who can complete long-term training in Europe or the USA is limited high cost long absence from primary job responsibilities.
Aims To develop and implement a 2-week research training course objectives a) provide a state-of-the-art review of research in blood donor selection and laboratory testing methodologies currently utilized to minimize the risk of Transfusion transmitted infections b) provide practical training in epidemiology and clinical research methods Impart the necessary skills to design and conduct studies at their own blood centers Overarching goal of improved blood transfusion safety
TRAINING IN CLINCAL RESEARCH (TICR)
Target Audience Professionals already working in blood transfusion who wish to pursue clinical research in their own blood centers Junior medical doctors PhD s Senior technicians with leadership potential Other? Requires commitment from senior management to facilitate the trainee s research career
1. Morning Lectures Curriculum Experts in transfusion medicine and epidemiology teach epidemiology of Transfusion Transmitted Infections principles of clinical research Lectures follow the textbook: Hulley SB et al. Designing Clinical Research (3 rd edit.), 2007. Illustrated with examples from the expert s own research or relevant literature
2. Afternoon workshops Each trainee must bring to the course a research question relevant to his/her local blood bank During each afternoon workshop the trainee builds a new section of a 5-6 page research protocol based upon his/her research question Sections include the research question, aims, study design, background/ significance, eligibility and exclusion, methods, sample size calculation/ statistics and ethics After the course, the trainee is encouraged to complete the project with the support of their local blood bank and/or submit an application for funding.
Training Course History and Number of Trainees Date Place Trainees May 2004 Sao Paulo, Brazil 9 Sep 2005 Buenos Aires, Argentina 13 Oct 2006 Tegucigalpa, Honduras 7 May 2007 Paris, France* 7 Oct 2007 Johannesburg, South Africa 12 May 2008 Paris, France* 10 Sept 2008 Belo Horizonte, Brazil 16 Oct 2008 Durban, South Africa 10 May 2009 Paris, France* 11 Aug 2009 Recife, Brazil 17 Oct 2009 Cape Town, South Africa 12 May 2010 Paris, France* 13 Aug 2010 Rio de Janeiro, Brazil 14 Nov 2010 Kruger Park, South Africa 8 May 2011 Paris, France* 9 * Institut Pasteur; trainees from Francophone Africa TOTAL 168
Example of Trainee Protocols Cape Town 2009 What is the specificity of the HCV EIA in Malawi? Estimates of HIV incidence using S/LS EIA. RCT of platelet vs. WB donations to lower adverse reaction rates in females Utility of TPHA as surrogate marker for HIV Prospective cohort to measure false-positive rate of the HIV S/LS EIA assay Case control study of automated vs manual cross match in reducing Tx reactions RCT of e-learning vs. classroom training for blood bank technicians in S. Africa Comparison of blood usage between rural vs. urban hospital locations Do donors deferred for high risk practices have an increased prevalence of HIV? Rate of donor return for ID marker notification & counseling, by age and gender. FFP Usage in Western Cape compared to European norms. Donor compliance with an iron supplementation program.
Manuscript Writing Course Modeled on UCSF Global Health course (McFarland/Rutherford) Students previously enrolled in TICR course and most with mini-grant awards First course Kruger Park, South Africa November 2010: 8 students Most emerged with completed first drafts Ambitious timeline: need longer than the 4.5 days originally scheduled
Medium Term Training 1-2 fellows come to San Francisco for 6-12 weeks Participate in UCSF Training in Clinical research (TICR) course or ITAPS manuscript writing course (50% effort) Epidemiology or lab-based research training at Blood Systems Research Institute/BSRI (50% effort) Costly: $8,000-$10,000 per fellow vs. $2,000-$2,500 for in country courses
Next steps Long-Term Training Contingent upon additional funding, hope to offer: MPH degree (15 months at UC Berkeley) MS Global Health (1 year at UCSF) MS/PhD studies in-country in Brazil or South Africa But very costly: ~ $50,000 per trainee
Mini Grants Awarded $5000 grants $5000 grants competition each December Research protocols judged by committee of 3 scientistsawarded on scientific merit likelihood of success Awardees to date South Africa: 8 Francophone Africa 11 Latin America 3
Transfusion TICR Publications Goncalez TT, Sabino EC, Murphy EL, Chen S, Chamone DA, McFarland W. Human immunodeficiency virus test-seeking motivation in blood donors, Sao Paulo, Brazil. Vox Sang 2006;90:170-6. de Almeida Neto C, McFarland W, Murphy EL, Chen S, Nogueira FA, Mendrone A Jr, Salles NA, Chamone DA, Sabino EC. Risk factors for human immunodeficiency virus infection among blood donors in Sao Paulo, Brazil, and their relevance to current donor deferral criteria. Transfusion 2007;47:608-14. Goncalez TT, Sabino EC, Chen S, Salles NA, Chamone DA, McFarland W, Murphy EL. Knowledge, Attitudes and Motivations Among Blood Donors in São Paulo, Brazil. AIDS Behav 2008;12(4 suppl):s39-47. Epub 2008 Apr 4. Almeida Neto C, Murphy EL, McFarland W, Mendrone Junior A, Chen S, Chamone DAF, Sabino EC. Changes in the profile of blood donors with reactive serologic tests for syphilis in Sao Paulo, Brazil and its relevance to blood bank practice. Transfusion 2009;49:330-6. Tagny CT, Diarra A, Yahaya R, Hakizimana M, Nguessan A, Mbensa G, Nebie Y, Dahourou H, Mbanya D, Shiboski C, Murphy E, Lefrere JJ. Characteristics of blood donors and donated blood in sub-saharan Francophone Africa. Transfusion 2009 Mar 10. Laperche S, Boukatou G, Kouegnigan L, Nébié Y, Boulahi MO, Tagny CT, Yahaya R, Tapko JB, Murphy E, Lefrère JJ. Transfusion safety on the African continent: an international quality control of virus testing in blood banks. Transfusion 2009 Jun 10. Jagannathan L, Rice M, Chaturvedi M, Murphy EL et al. Risk factors for chronic hepatitis B virus infection among Indian blood donors. Transfusion Med 2010; 20:414-420.
Funding for the Training Project Blood Systems Research Institute US National Institutes of Health grants NHLBI K24-HL-075036 (Murphy) FIC D43-TW000003 (Reingold) FIC D43-TW05799 (Rutherford) Institut Pasteur (in kind) Industry: Chiron/Novartis International Society of Blood Transfusion UCSF Center for AIDS Research/Fogarty grant Brazilian Ministry of Health South African National Blood Service (in kind)
After seven years Conclusions A short course in clinical and epidemiological research has already been instrumental in stimulating blood safety research in low and middle income countries, and in promoting collaborations Ongoing process with courses planned for June (Manaus, Brazil) and November (Africa) Future plans include Obtaining funding for masters and doctoral level training of promising candidates Starting a web-based system for networking and communication among former trainees
Acknowledgements UCSF/BSRI Edward Murphy, MD, MPH