Change is in the air in relation to EU clinical trials of medicinal products. The European Commission published a draft Regulation in July to amend the procedures. As a Regulation, when adopted, it will have direct effect and will not need legislation in each Member State to implement is. This should help avoid many of the complaints about the current legislation about the variations in the rules across different Member States.
Just a few of the key changes are:
- The new regime recognises the varying risk levels that different trials have rather than adopting a one size fits all. It introduces new or amended definitions of a clinical trial, a clinical study, a low intervention clinical trial and a non-interventional trial. A low intervention clinical trial is completely new and covers trials of authorised drugs on label with no greater risk than normal clinical practice. The regime is also less onerous for a low-intervention clinical trial: for instance the basic time limit for responding to a valid clinical trial application is only 10 days.
- Trials can be co-sponsored. So for instance where universities and NHS Trusts are carrying out a trial together they can each agree to take direct responsibility for their aspects of the trial rather than one having to take the direct responsibility and sub-contracting relevant aspects to the other.
- Each Member State will have to provide a national indemnification mechanism for compensating damage suffered by a clinical trial subject (other than for a low-intervention clinical trial). the sponsor can use this scheme to comply with its compensation obligations. Any national indemnification mechanism will be free of charge if the trial was not intended to be used to obtain a marketing authorisation. This could be helpful for some university research.
The Regulation is expected to take effect in 2016.
The Association of the British Pharmaceutical Industry (ABPI) has also issued new Guidelines for phase 1 clinical trials recognising that most of them nowadays are carried out by contract research organisations (CROs) and that many sponsors are from outside the UK.