The beauty of ECCMID is the abundance of investigator-initiated studies being presented. The cruelty is that the logistical nightmares that each presenter has gone through to get that study approved and done, cannot be reflected in a 10-minute oral or on a poster. The good news, though, is that that will change: the EU directive 536/2014 will make everything much easier and faster, in order “to let more European patients benefit from recent scientific achievements”. True? …. or does it reduce investigator-suffering by just killing any investigator-initiated study initiative?
A staff member of our IRB explained the consequences of this directive, fully effective in 2019, earlier this week. So, initially this will apply to all types of research with investigational products, investigator-initiated as well as pharmacy-initiated, and national and international. No escape.
To make things easier all submissions shall go through 1 single EU portal, and for international studies there will be a central and a national review part, with the reporting Member State taking care of the national part. To speed up things there will be short and strict timelines. You pay (no price set yet), submit your protocol and all paperwork, and then the first review phase can take a max of 45 days. After that, the investigator will have 1 (!) possibility to answer questions and – to speed up things – that must be done in 12 days! Not in time? You have to start all over again (… with paying, as when sent to jail in the monopoly game). So, when submitting, carefully avoid holidays between day 15 and 60 after submission!
Based on the response the review board will approve or not. And if not, sorry, no study. If you get approval for a multicenter study and if you’re still identifying study sites, be aware that sites can only be added (through an amendment) every 3 months. And if you ever experienced benefits in actually talking to local IRB members to get guidance for a specific submission: that slows down processes, and is, therefore, no longer possible.
The totally depressed audience of clinical investigators agreed that this indeed will be a much faster approval process, but also feared that it will kill many initiatives in the phase of study conception. Rumor has it that this directive was actively propagated by big pharma……, that will have the infrastructure to do all this and then can monopolize the field of clinical research. Just a rumor, though.
This is an EU directive, so there seems no way of stopping this. What can we do?
- Try to convince your government to leave the EU?
- Set up a local “mock IRB” to pre-approve submissions before you take the big leap.
- Just stick to comparative effectiveness research (my talk at ECCMID).
- Make sure you have the infrastructure and finances to survive this logistical rollercoaster.
So, if at ECCMID enjoy the – may be – last generation of investigator-initiated clinical studies. Prozac may help, as well.
PS: it might be that I missed essential information resulting in an overly skeptic interpretation, for which I apologize upfront.