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

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dc.contributor.authorGeldenhuys, H
dc.contributor.authorVeldsman, A
dc.contributor.authorTameris, M
dc.contributor.authorLuabeya, A
dc.contributor.authorHanekom, W
dc.contributor.authorMahomed, H
dc.contributor.authorHatherill, M
dc.date.accessioned2021-10-08T07:18:02Z
dc.date.available2021-10-08T07:18:02Z
dc.date.issued2013
dc.description.abstractBackground. 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. Aim. 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. Method. 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. Conclusion. 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.
dc.identifier.apacitationGeldenhuys, H., Veldsman, A., Tameris, M., Luabeya, A., Hanekom, W., Mahomed, H., & Hatherill, M. (2013). Analysis of time to regulatory and ethical approval of SATVI TB vaccine trials in South Africa. <i>South African Medical Journal</i>, 103(2), 85 - 177. http://hdl.handle.net/11427/34889en_ZA
dc.identifier.chicagocitationGeldenhuys, H, A Veldsman, M Tameris, A Luabeya, W Hanekom, H Mahomed, and M Hatherill "Analysis of time to regulatory and ethical approval of SATVI TB vaccine trials in South Africa." <i>South African Medical Journal</i> 103, 2. (2013): 85 - 177. http://hdl.handle.net/11427/34889en_ZA
dc.identifier.citationGeldenhuys, H., Veldsman, A., Tameris, M., Luabeya, A., Hanekom, W., Mahomed, H. & Hatherill, M. 2013. Analysis of time to regulatory and ethical approval of SATVI TB vaccine trials in South Africa. <i>South African Medical Journal.</i> 103(2):85 - 177. http://hdl.handle.net/11427/34889en_ZA
dc.identifier.issn0038-2469
dc.identifier.ris TY - Journal Article AU - Geldenhuys, H AU - Veldsman, A AU - Tameris, M AU - Luabeya, A AU - Hanekom, W AU - Mahomed, H AU - Hatherill, M AB - 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. Aim. 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. Method. 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. Conclusion. 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. DA - 2013 DB - OpenUCT DP - University of Cape Town IS - 2 J1 - South African Medical Journal LK - https://open.uct.ac.za PY - 2013 SM - 0038-2469 T1 - Analysis of time to regulatory and ethical approval of SATVI TB vaccine trials in South Africa TI - Analysis of time to regulatory and ethical approval of SATVI TB vaccine trials in South Africa UR - http://hdl.handle.net/11427/34889 ER - en_ZA
dc.identifier.urihttp://hdl.handle.net/11427/34889
dc.identifier.vancouvercitationGeldenhuys H, Veldsman A, Tameris M, Luabeya A, Hanekom W, Mahomed H, et al. Analysis of time to regulatory and ethical approval of SATVI TB vaccine trials in South Africa. South African Medical Journal. 2013;103(2):85 - 177. http://hdl.handle.net/11427/34889.en_ZA
dc.language.isoeng
dc.publisher.departmentMRC/UCT Child and Adolescent Health Unit
dc.publisher.facultyFaculty of Health Sciences
dc.sourceSouth African Medical Journal
dc.source.journalissue2
dc.source.journalvolume103
dc.source.pagination85 - 177
dc.source.urihttps://dx.doi.org/10.7196/SAMJ.6390
dc.subject.otherregulatory approval
dc.subject.otherclinical trials
dc.subject.othertuberculosis vaccine trials
dc.subject.otherMedicines Control Council (MCC)
dc.subject.otherresearch ethics committee (REC)
dc.titleAnalysis of time to regulatory and ethical approval of SATVI TB vaccine trials in South Africa
dc.typeJournal Article
uct.type.publicationResearch
uct.type.resourceJournal Article
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