title: Analysis of time to regulatory and ethical approval of SATVI TB vaccine trials in South Africa.
abstract: BACKGROUND
  Tuberculosis (TB) vaccine trials in South Africa must be approved by the Medicines Control Council (MCC) and by a human research ethics committee (HREC). Delays in regulatory and ethical approval may affect operational and budget planning and clinical development of the product.
  
  
  OBJECTIVE
  Our aim was to analyse the time to regulatory and ethical approval for TB vaccine trials conducted by the South African Tuberculosis Vaccine Initiative (SATVI) and to evaluate factors that influence time to final approval.
  
  
  METHODS
  Sixteen new TB vaccine clinical trials conducted by SATVI between 2004 and 2012 on infants, children, and adults were included. The period between submission and final approval was determined for protocols submitted to the MCC and the University of Cape Town HREC.
  
  
  RESULTS
  Median approval time following first submission to the MCC was 122 days (IQR 112 - 168; range 71 - 350), and for protocol amendments 103 days (interquartile range (IQR) 76 - 141; range 23 - 191; n=30). Median time following first submission for HREC approval was 60 days (IQR 33 - 81; range 18 - 125), and for amendments 6 days (IQR 4 - 13; range 1 - 37; n=30). There was no significant difference in approval time by trial phase, year of submission, revisions required, study population, sample size, or whether a clinical research organisation (CRO) was used.
  
  
  CONCLUSIONS
  The time needed for regulatory and ethics approval was highly variable, but MCC approval for first submissions took twice as long as HREC approval and was the primary determinant of time to final approval. National regulatory capacity should be strengthened to facilitate the conduct of new TB vaccine trials in this country with its high burden of TB.
authors: South African Tuberculosis Vaccine Initiative (SATVI), Institute of Infectious Disease and Molecular Medicine (IIDMM), University of Cape Town, South Africa. hennie.geldenhuys@uct.ac.za
authors: H
authors: H
authors: Geldenhuys
authors: A
authors: A
authors: Veldsman
authors: M
authors: M
authors: Tameris
authors: A
authors: A
authors: Luabeya
authors: W
authors: W
authors: Hanekom
authors: H
authors: H
authors: Mahomed
authors: M
authors: M
authors: Hatherill
mesh_terms: D000293:Adolescent; D000328:Adult; D002648:Child; D002675:Child, Preschool; D002986:Clinical Trials as Topic / Q000941:ethics*; D028744:Ethics Committees, Research / Q000706:statistics & numerical data*; D005260:Female; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D008297:Male; D009017:Morbidity / Q000639:trends; D013019:South Africa / Q000453:epidemiology; D013997:Time Factors; D014376:Tuberculosis / Q000453:epidemiology / Q000517:prevention & control*; D032581:Tuberculosis Vaccines / Q000494:pharmacology*; D055815:Young Adult
chemical_list: D032581:Tuberculosis Vaccines