DSUR Non Commercial development management

[MTS]

FYI - the new (17 Jul 2012) Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC states that the annual safety report is not submitted for authorised investigational medicinal products that are used within their authorised indication.
This should reduce the number of DSURs a non-commercial sponsor would have to prepare. Expected to come into effect in 2016.

[Terraldinho]

Thanks all for your comments. I guess the issue here is that as non-commercial sponsors, we do not maintain the global safety data on a particular product, and the DSUR is best sat with the pharma companies rather than an NHS trust. In the absence of a contract with pharma to write this on our behalf, I wanted to know how other organisations manage safety data without the resources and structure of a large pharma company (i.e. central point of reporting, recording and maintaining safety data).

MTS: my query was in reference to a trust as sponsor with safety data maintenance delegated to the CI. There may be several trials using the same IMP, in different populations and disease areas. It may not be appropriate for individual CIs to comment on the safety implications of a drug used in a different patient population/ disease area, thereby making it unfair for any individual CI to assess all data and write a DSUR for an IMP.

Nev Young: I agree that the drug company should write this report, as this is the intended purpose, but they are not obliged to do this as they are not sponsoring the trials. To date, we have also submitted trial-based DSURs rather than IMP-based (as should be), and justified this on the basis that the populations are sufficiently different.

Thanks again