1 / 10

South Africa Medical Journal (SAMJ), Feb 2013

South Africa Medical Journal (SAMJ), Feb 2013. Objective. Describe the median regulatory and ethics approval time for tuberculosis vaccine trials conducted at SATVI Describe approval time according to trial-specific protocol and submission factors. Method.

britanni-tillman
Download Presentation

South Africa Medical Journal (SAMJ), Feb 2013

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. South Africa Medical Journal (SAMJ), Feb 2013

  2. Objective • Describe the median regulatory and ethics approval time for tuberculosis vaccine trials conducted at SATVI • Describe approval time according to trial-specific protocol and submission factors

  3. Method TB vaccine trials conducted by SATVI (2004-2012) Approval Time= date of submission to date on approval letter Protocol factors By body (MCC; HREC)By submission (1st; amendment)

  4. Results • 15 TB vaccine trials (each to MCC and HREC) • 30 amendments across all trials (each to MCC and HREC)

  5. Results Median times (in days): 1st  MCC 118 (112-175), range 71-350 HREC 59 (30-74) range 17-125 amendment  MCC 103 (76-141), range 23-191 HREC 6 (4-13) range 1-37

  6. Results

  7.     All p > 0.1

  8. Summary • Approval times: National Regulatory Body (MCC) is the driver • Determinants of review time: protocol factors vs capacity factors • Variability and unpredictability • 1st submission vs amendment

More Related