Analysis of time to regulatory and ethical approval of SATVI TB vaccine trials in South Africa

South African Medical Journal

Volumn 103, Issue 2, 2013, Pages 85-89

  Geldenhuys, H ^a   Veldsman, A ^a   Tameris, M ^a   Luabeya, A ^a   Hanekom, W ^a   Mahomed, H ^a   Hatherill, M ^a  

^a UNIVERSITY OF CAPE TOWN   (South Africa)

Author keywords

[No Author keywords available]

Indexed keywords

BCG VACCINE;

ARTICLE; CLINICAL PROTOCOL; DRUG APPROVAL; ETHICS; HUMAN; LAW; PHASE 1 CLINICAL TRIAL; PHASE 2 CLINICAL TRIAL; POPULATION RESEARCH; REGULATORY MECHANISM; SAMPLE SIZE; SOUTH AFRICA; TIME; TUBERCULOSIS;

ADOLESCENT; ADULT; CHILD; CHILD, PRESCHOOL; CLINICAL TRIALS AS TOPIC; ETHICS COMMITTEES, RESEARCH; FEMALE; HUMANS; INFANT; INFANT, NEWBORN; MALE; MORBIDITY; SOUTH AFRICA; TIME FACTORS; TUBERCULOSIS; TUBERCULOSIS VACCINES; YOUNG ADULT;

EID: 84873263769     PISSN: 02569574     EISSN: None     Source Type: Journal    
DOI: 10.7196/SAMJ.6390     Document Type: Article

References (13)

1. Bollyky TJ, Cockburn IM, Berndt E. Bridging the gap: improving clinical development and the regulatory pathways for health products for neglected diseases. Clin Trials 2010;7(6):719-734. [http://dx.doi.org/10.1177/1740774510386390]
2. Jindani A, Griffin GE. Challenges to the development of new drugs and regimens for tuberculosis. Tuberculosis 2010;90(3):168-170. [http://dx.doi.org/10.1016/j.tube.2010.03.006]
3. Baird D, van Niekerk D. The regulation of clinical trials in South Africa. Qual Assur J 2004;8:33-36. [http://dx.doi.org/10.1002/qaj.252]
4. Hanekom WA, Hawkridge A, Mahomed H, et al. SATVI - after 10 years closing in on a new and better vaccine to prevent tuberculosis. S Afr Med J 2012;102(6):438-441.
5. Kagina BM, Abel B, Scriba TJ, et al. Specific T cell frequency and cytokine expression profile do not correlate with protection against tuberculosis after bacillus Calmette-Guerin vaccination of newborns. Am J Respir Crit Care Med 2010;182(8):1073-1079. [http://dx.doi.org/10.1164/rccm.201003-0334OC]
6. Soares AP, Scriba TJ, Joseph S, et al. Bacillus Calmette-Guerin vaccination of human newborns induces T cells with complex cytokine and phenotypic profiles. J Immunol 2008;180(5):3569-3577.
7. Scriba TJ, Kalsdorf B, Abrahams DA, et al. Distinct, specific IL-17- and IL-22-producing CD4+ T cell subsets contribute to the human anti-mycobacterial immune response. J Immunol 2008;180(3):1962-1970.
8. South African Clinical Research Association home page. www.sacraza.com (accessed 13 September 2012).
9. Asamoah AK, Sharfstein JM. Transparency at the Food and Drug Administration. N Engl J Med 2010;362(25):2341-2343. [http://dx.doi.org/10.1056/NEJMp1005202]
10. Heerspink HJ, Dobre D, Hillege HL, Grobbee DE, De Zeeuw D. Does the European Clinical Trials Directive really improve clinical trial approval time? Br J Clin Pharmacol 2008;66(4):546-550.
11. Mallick AA, O'Callaghan FJ. Research governance delays for a multicentre non-interventional study. J R Soc Med 2009;102(5):195-198. [http://dx.doi.org/10.1258/jrsm.2009.080397]
12. Salman RA, Dennis MS, Sandercock PAG, White PM, Warlow C. Research governance impediments to clinical trials: a retrospective survey. J R Soc Med 2007;100:101-104. [http://dx.doi.org/10.1258/jrsm.100.2.101]
13. Chester P, Alaam S, Cooper P, Risley C, Dornhorst A. Local clinical trial approval times in the UK. International Journal of Pharmaceutical Medicines 2006;20(5):317-320. [http://dx.doi.org/10.2165/00124363-200620050-00006]