Andrew Smith
Keywords
EMEA, EU Clinical Trials Directive, FDA, Highlights of 2009, Model contracts, News review, Transparency
It’s been a tough year. As Janette Benaddi says in her column this month, most of us are slogging through to the end of 2009 battered and bruised by the economic turbulence, the accelerating strategic shift in where clinical research is being conducted and, more insidiously, the feeling of uncertainty that all of us are feeling as a result of these factors. Still, it is also important to recognise that there have been some positive developments in the sector, some of which will continue to have an impact long after this recession is gone and forgotten.
The EMEA moved ahead with a new version of the EudraCT database (
www.icr-global.org/resources/news/?EntryId23=5080) with plans for two more revisions well under way. The Agency has also embarked on a significant reorganisation of its key structures (
www.icr-global.org/resources/news/?EntryId23=5837) and is expected to have launched a new website (www.ema.europa.eu) to reflect this by the time you read this.
In the USA, the change of leadership at the FDA has been widely seen as a positive move, giving the Agency the mandate and the resources (in the form of a $393m increase in its budget;
www.icr-global.org/resources/news/?EntryId23=5393) to transform its operations, reduce delays and interact more vigorously with the clinical research community. This also comes with more “teeth” to hold investigators, sponsors etc. to account, which might be inconvenient to some, but will be hugely influential in raising the standards of clinical trial conduct. One of the first successes of the new-look FDA was the mandatory registration of all Institutional Review Boards (
www.icr-global.org/resources/news/?EntryId23=5463), in the wake of the ‘sting’ operation by the Government Accountability Office which trapped the Coast IRB in Colorado approving an entirely fictitious study (
www.icr-global.org/resources/news/?EntryId23=4960). The FDA has also been working increasingly closely with the EMEA, to harmonise the administration and conduct of inspections between the two regions. This started early in 2009 with GMP inspections, but was extended in August to cover GCP inspections (
www.icr-global.org/resources/news/?EntryId23=5565).
Things have also improved on the transparency front, with the EMEA drafting a transparency policy in June (
www.icr-global.org/resources/news/?EntryId23=5236) and use of the Indian clinical trial registry becoming mandatory from the same month (
www.icr-global.org/resources/news/?EntryId23=4965). The Indian registry was later adopted into the World Health Organisation Registry Network. The IFPMA also updated its policy on trial disclosure in November (
www.icr-global.org/resources/news/?EntryId23=6149). Another development in this area was the publication of a revised code of practice by the UK Research Integrity Office (
www.icr-global.org/resources/news/?EntryId23=5576).
Medical device studies in the UK have also started to see some of the measures previously only applied to pharmaceutical studies: a model contract for use between sponsors and investigational sites was launched early in 2009, and was followed-up by a variant to include a CRO in the process over the summer (
www.icr-global.org/resources/news/?EntryId23=5260).
Also taking place over the summer, several important reports were published, examining the impact of the EU Clinical Trials Directive (
www.icr-global.org/resources/news/?EntryId23=5235) with a view to what revisions might be appropriate, surveying the future of genomic medicine (
www.icr-global.org/resources/news/?EntryId23=5338), and aiming to reinvent UK healthcare with innovation at its core (
www.icr-global.org/resources/news/?EntryId23=5421 and
www.icr-global.org/resources/news/?EntryId23=5395). It remains to be seen how much of an impact these reports might have on the future of clinical research.
As you will have noticed, most of these important developments were featured in the ICR member’s news service, available on our website and by fortnightly email, where we select only the most relevant news about changes that will impact how clinical research is conducted and managed. To stay up to speed with these developments, bookmark
www.icr-global.org/resources/news or visit the page and link to our RSS feed.
Over the next few pages, we will turn our gaze to the next few years, and ICR members and expert commentators will speculate and offer insights into the world of clinical research will continue to evolve and what key drivers (eg, accelerating globalisation, changing reimbursement policies, ‘personalised’ medicine and even a replacement for the EU Clinical Trials Directive) might have a significant role in shaping our future. CRfocus, and ICR as a whole, is looking forward to navigating these turbulent times with you, in the hope that, although 2009 was tough, 2010 might turn out to be an “annus mirabilis”.
Let’s hope so…
Andrew Smith is Editor of Clinical Research focus.
