Peter O'Donnell
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Europe remains as challenging as ever for clinical trials, but also for everyone trying to make sense of Europe as a political
entity. The jumbo meeting on clinical trials at the European Medicines Agency in early October—on which a report appears at
http://www.actmagazine.com/appliedclinicaltrials/Clinical+Trials/Composite-Endpoints-Proceed-with-Caution/ArticleStandard/Article/detail/463968—provided further evidence of just how complex life can become in the European Union. This unique organization binds 27 member
states together tightly, voluntarily, legally—but not completely. And the conduct of clinical trials is one of the activities
that keeps slipping between the gaps in the curious configuration of EU rules, which resemble wickerwork more than cast-iron.
This is not the place for a lengthy disquisition on the constitution of the EU. Suffice it to say that the 27 member states
not only disagree with one another on clinical trials regulation, but that even where they do agree in principle, they frequently
disregard at national level the rules they have created at the European level.
At the end of the meeting at the Agency, Georgette Lalis, the senior official from the European Commission, openly acknowledged
that the majority of member states just do not comply with the guidelines they have signed up to on clinical trials. Worse,
under the system in force, there is no way that either the European Commission—supposedly the watchdog of compliance —or the
Agency can do anything to oblige member states to comply.
EU Documents Set for Release in Early 2008
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Thomas Lönngren, the executive director of the European Medicines Agency, told Applied Clinical Trials that it was outside his powers. The Agency handles only some of the technical work on clinical trials, such as site inspections
and databases, he insisted. "It is not involved in clinical trials legislation. That is in the hands of the member states
and it is their responsibility," he underlined. And, he made clear, it will require "a political decision" to change the system.
Undiminished energy
Nonetheless, the key clinical trials experts at the Agency have, meanwhile, been looking ahead with undiminished energy. The
Agency's efficacy working party has just agreed on its workplan for the next two years under its chairperson Dr. Barbara van
Zwieten-Boot of the Netherlands. In terms of direct contact with individual sponsors, it expects to provide support in terms
of scientific advice on 15 occasions each year, protocol assistance five times a year, product assessment six times a year,
and postauthorization pharmacovigilance issues related to a product or a class of products just twice a year.
But the bulk of the work will, as usual, consist of the generation or revision of guidelines for efficacy testing. The ones
to watch out for particularly are those still in the consultation process because there, everyone in the clinical trials community
has a chance to influence the outcome. The first quarter of 2008 looks like it will see a volley of consultation documents
released. A revised draft on clinical development of medicinal products for treatment of HIV infection is expected to be released
for consultation in early 2008, following the adoption of a concept paper last February. So too are drafts of new guidelines
on the clinical development of medicinal products for tuberculosis and Hepatitis C, now that there has been time to digest
comments on the concept papers adopted in April 2007 (see Table on page 38 for a list of other consultation documents expected
to see the light of day next year).
No cynicism
A cynic might be tempted to discourage the clinical trials community from getting involved in a discussion of these guidelines
if the member states are not going to take them seriously. But cynicism has no place in Europe—or in this column. In general,
the guidelines from the efficacy working party have tended to harmonize thinking—among regulators as well as sponsors—on new
medicines development. The conspicuous member state noncompliance at present relates to the detailed guidance on methodology
for the conduct of clinical trials in line with good clinical practice.
