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Applied Clinical Trials
The EU struggles to get over its regulatory hurdles in an effort to further R&D success.
Everyone involved in clinical trials is, almost by definition, working toward a better future. It's why they get involved in medicine development in the first place. Better medicines means a better life for patients and carers—and often for payers, too—and that can make a real contribution for a better future.
But the better future that many in Europe are working toward at present is not simply directed at improving medicines. It is directed at improving the rules that govern the development of medicines—and notably that frequently maligned piece of European Union legislation, the 2001 clinical trials directive.
It looks like the EU authorities are, next year, going to bow (or at any rate make a slight inclination) to the waves of criticism of this ill-starred rule, and offer some form of revision. Nothing is yet definite, because the European Commission—in effect, the executive body of the EU—is currently in a state of semi-paralysis for reasons utterly remote from the world of clinical trials. This is unlikely to be resolved until the end of 2009, at the earliest.
Many in the clinical trials community are not letting that uncertainty get in the way of their own reflections on what should be done to improve the circumstances in which clinical trials are conducted in Europe. There is an almost constant exploration of options among practitioners in industry, academia, and the regulatory authorities themselves.
This column commented in August on the first in a series of workshops jointly organized by groups with specific interests in clinical trials, ranging from stem cells to cancer, and from infrastructure to good clinical practice. That first workshop focused on the desirability of a single clinical trial authorization in Europe, and the recently released report of the meeting workshop stresses that "delegates were not prepared to rule out options simply because their achievement might require legislative change and lengthy timescales." It goes on to list "ideas for immediate action to fix the existing system"—including establishing an identical dossier for multiple applications submitted to a centralized database; adaptation of the rules to allow cosponsorship; and reduced burdens linked to reporting suspected unexpected severe adverse reactions.
The program of meetings over coming months is ambitious. The "Road Map Initiative for Clinical Research in Europe," as it styles itself, held another workshop, on cosponsorship, in London in September. In January it will look at risk-based approaches and ethics committees, and at pharmacovigilance in February 2010. The workshops aim to bring together commercial and noncommercial sponsors, investigators, ethics committees, competent authorities, and patients. Based on the discussions, a final conference will be held in April 2010 with a view to agreeing on a clear and united proposal and submitting it to the European Commission on the way forward for multinational clinical trials in Europe.
Groups organizing the workshops within the "Road Map Initiative for Clinical Research in Europe" include:
The September workshop, on innovative approaches to clinical trial cosponsorship in the EU, takes as its starting point the clinical trials directive requirement for a single sponsor with legal responsibility for the initiation, management and/or financing of a clinical trial.
"In multinational trials, the demands this places on the sponsor are particularly onerous considering the widely varying implementation of the directive," say the organizers, and in consequence, many organizations are unwilling or unable to take on this role. Academic institutions are particularly discouraged by their own legal limitations and the risks and high associated costs of fulfilling the responsibilities, leading to a fall-off in the number of academic investigator-led trials on a multinational level.
Mechanisms need to be found, they argue, that would enable sponsors to formally and legally share responsibility for the management and financing of clinical trials, such as delegation of certain responsibilities in cosponsorship.
A series of regional workshops are also being held over the coming months designed to define the needs and mechanisms for more partnerships between patients, patient organizations, and other stakeholders in clinical trials.
PatientPartner, as the project is called, is investigating, enforcing, and advising on the role of patient organizations in clinical trials. The underlying purpose is to extend the concept of patients in clinical research beyond the role of a "subject" in a clinical trial, so as to take advantage of what else patients and patient organizations can offer the clinical trial process. A partnership with pharmaceutical companies or clinical researchers could bring benefits to patients and to the quality, quantity, and effectiveness of clinical research.
The project is making inventories of the needs of patient organizations in respect of involvement in clinical research, and of the needs and expectations of other stakeholders. It will generate a European Network of Patients partnering in clinical research able to provide advice and to create a European network to interact with other stakeholders in the clinical trials field.
A first workshop in Brussels last June is being followed by a two-day regional workshop in London in October, for the northwestern region, by a central and eastern European workshop at the end of November in Budapest, and then by a southern European workshop next March. Each workshop covers the local aspect of issues such as access to information, patient rights, cultural and political factors, and relations between stakeholders. The resulting recommendations will be further discussed and developed during a final central workshop in Brussels next year, after which recommendations will be refined and addressed to key European stakeholders.
Meanwhile, the newly elected European Parliament is starting to turn its attention to the latest legislative proposals from the European Commission—the so-called "pharmaceutical package," which urges tighter rules on pharmacovigilance, tougher action against counterfeiting, and a wider scope for drug firms to tell patients about their prescription medicines.
The draft rules on pharmaco-vigilance include better-defined roles and responsibilities for the principal actors in medicines provision, clearer rules so that pharmacovigilance systems pick up relevant high-quality data, and—consistent with recent broader EU initiatives—closer involvement of everyone involved, including patients. Discussion of the proposals by national governments in the EU Council has so far focused largely on the composition, role, and mandate of the proposed new EU-level pharmacovigilance committee. European Commission Vice President Günter Verheugen, responsible for the industry dossier in the Commission—and hence for much of the EU legislation on medicines—appeared before the parliament's health committee on September 1 to discuss progress on the proposals.
"We shouldn't wait for disaster. We should act in a preventive way, and the time is now." He said he foresaw no major problems with advancing this proposal through the legislative machinery, and expressed hope for a rapid solution "so the pharmaceutical industry knows what lies ahead."
German Socialist Dagmar Roth-Behrendt, one of the heavyweights re-elected to the new parliament, accused the EU member countries of moving very slowly on pharmacovigilance, particularly on contentious issues such as a central database.
UK Socialist Linda McAvan, who has been appointed by the committee to draft the parliament's report on pharmacovigilance, insisted that the upcoming discussions should focus on patient safety, and "not on who should be on committees, as the Council discussions seem to be obsessed with." She also said the scheme would need proper funding.
McAvan, whose influence has been strengthened further by the fact that her party has also appointed her its senior spokesman on the committee, is another veteran of the parliament. She has shown understanding in the past for drug industry issues. Back in 2007, during tense discussions of the EU's new rules to ease the marketing rights across Europe of advanced medicines, she came out strongly in support of the proposal in crucial votes.
The pharmaceutical industry in Europe will welcome the sound of the voice of reason in the discussions of the complex and sensitive subject over the coming months.