DSUR Non Commercial development management

[Terraldinho]

Hello All

We would like to know if any other non commercial organisations have any experience that they would like to share regarding the logistics of collating information required to develop a DSUR. E.g. A single IMP is used across multiple chief investigators in the absence of a centralised safety desk with a medical monitor.

Look forward to hearing your responses.

[MTS]

There is a model DSUR for non-commercial sponsors on the ICH web site (http://www.ich.org/fileadmin/Public_...rcial_DSUR.pdf)

For your scenario, are you referring to different trials with each chief investigator considered a sponsor? And each chief investigator assesses and reports SUSARs during the trial? But they want to generate one DSUR (as recommended by ICH E2F).
For one DSUR, the SAEs need to be collated in order to generate a listing of SARs in the yearly period and a listing of SAEs since the study started.
Hope this helps.

[Nev Young]

Where we are responsible for the DSUR we specifically state that the DSUR is Trial specific. So we put a DSUR in for each trial we sponsor. What we are increasingly trying to do is agree for a commercial drug company supplying IMP to do the DSUR and we can cross reference that annually and receive the exec summary. This can mean we have to be very tight with reporitng PhV events to the company but it seems like a fair exchange.

[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