South African Tuberculosis Vaccine Initiative (SATVI), Institute of Infectious Disease and Molecular Medicine (IIDMM), University of Cape Town, South Africa.
S Afr Med J. 2012 Nov 8;103(2):85-9. doi: 10.7196/samj.6390.
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.
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.
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.
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.
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.
南非的结核病（TB）疫苗试验必须经过药品管制委员会（MCC）和人类研究伦理委员会（HREC）的批准。监管和伦理批准的延迟可能会影响产品的运营和预算规划以及临床开发。
我们的目的是分析南非结核病疫苗倡议（SATVI）进行的结核病疫苗试验的监管和伦理批准时间，并评估影响最终批准时间的因素。
纳入了 2004 年至 2012 年期间由 SATVI 进行的 16 项新的结核病疫苗临床试验，这些试验涉及婴儿、儿童和成年人。确定了向 MCC 和开普敦大学 HREC 提交的方案的提交到最终批准之间的时间段。
向 MCC 首次提交后的批准时间中位数为 122 天（IQR 112-168；范围 71-350），对于方案修正案为 103 天（IQR 76-141；范围 23-191；n=30）。向 HREC 首次提交后的批准时间中位数为 60 天（IQR 33-81；范围 18-125），对于修正案为 6 天（IQR 4-13；范围 1-37；n=30）。试验阶段、提交年份、所需修订、研究人群、样本量或是否使用临床研究组织（CRO）等因素对批准时间均无显著差异。
监管和伦理批准所需的时间高度可变，但 MCC 对首次提交的批准时间是 HREC 批准时间的两倍，是最终批准时间的主要决定因素。为了在这个结核病负担高的国家开展新的结核病疫苗试验，应加强国家监管能力。
