Honorary Professor Allan Saul, The Burnet Institute / University of Melbourne, Australia
A database has been assembled of the 700 dose-escalating trials of prophylactic, injectable vaccines published in papers classified as PubMed as "clinical trial, phase i"[Publication Type] or the Phase ii equivalent, since these PubMed classifications were introduced in 1992. This database contains a wealth of knowledge about past trials applicable to future trial design.
For example:
- details of the 22 trials in this database that were stopped or substantially modified because of the severity of adverse events,
- general findings on how human immune responses and adverse events scale with dose,
- the impact of adjuvants,
- how to maximize information from early-stage trials for planning Phase II and Phase III studies.
This project is still very much a “work in progress” and I’ll discuss how you can access the data and look for ideas on what further features/analyses would be useful.
