Posted by Claire Veryard, Thomson Scientific Ltd, London, UK
The Applied Clinical Trials – 13th Annual European Summit, Amsterdam, the Netherlands meeting held October 17th - 19th was attended by approximately 200 delegates from pharmaceutical companies, device manufacturers, CROs, data capture providers, logistics services and consultancy firms.
Topics covered at the meeting included regulatory and safety issues, trial design and management, electronic data capture, outsourcing, and offshoring. This summary of the report will highlights from of this year's event.
New clinical trials law in the Netherlands
The first day included a thorough overview of the regulations relating to clinical trials in the Netherlands by Herman Pieterse (MD, Profess Medical Consultancy, the Netherlands) and Jan Hasker Jonkman (University of Groningen, the Netherlands). The Medical Research in Human Subjects (WMO) Act of 1999, designed to address many of the same issues as the EU Clinical Trials Directive (CTD), was revised to align with the CTD in March 2006.
Joop van Gerven (Centre for Human Drug Research, the Netherlands) outlined the impact of these changes on clinical trial investigators. Most responsibilities have remained unchanged, but the investigator now has to submit to the CCMO documents including the EudraCT application form, IMPD, recruitment literature, subject questionnaires and insurance certificates.
The investigator is responsible for gaining approval from the ethics committee and for reporting SAEs and SUSARs to the sponsor, ethics committee and CCMO. In 2005, 1748 CTAs were submitted, including 28 assessed by the CCMO rather than an ethics committee, of which 651 involved pharmaceutical therapies. Of these, 280 were investigator - initiated, so significant proportions are being performed by people with variable training, support and resources.
The Netherlands Federation of University Medical Centres' 2006 report into clinical research facilities recommended improved training, formalization of research nurse/assistant roles, harmonization of research databases, and GMP and GLP certification for all academic hospital pharmacies and laboratories. Academic medical centers still need increased resources and training to fully meet the spirit of the legal changes.
An assessment of the post-CTD environment was presented by Ingrid Klingmann (President, Pharmaplex, Belgium). The CTD has improved timelines and standards, but there are still many inconsistencies between member states because they have interpreted the CTD differently. New guidance on SUSAR reporting was published in April 2006, but is not yet implemented throughout the EU. The Volume 10 Notice to Applicants guidance was released in July 2006. In addition, guidelines on non-investigational medicinal products, including rescue medication, challenge agents, imaging agents and drugs to control or provoke side effects, were published in October 2006.
Clinical trial sites: where and how?
Jean-Pierre Tassignon (PSI Pharma Support International, Switzerland) kicked off the 'Survival in the fast-changing regulatory landscape' session with some interesting statistics on clinical trials in Europe and North America. The total number of clinical trials in the UK, France and Germany has declined by about 30% since 2004, with the clinical trial subjects dropping from 23 to 16 per million population. In the US in 2006, this rate was 28 per million, compared with 41 million in Estonia, 29.7 million in the Czech Republic, 8.7 million in Poland and 2.4 million in Russia.
Failure rates of FDA inspections of clinical trial sites were 3% in the US and Canada, 5% in the EU, 38% in Mexico and 0% in Central and Eastern Europe (CEE). CEE nations also show rapid recruitment. These figures demonstrate that sites in Russia and Poland, with their excellent inspection results and low saturation of trial subjects, should be attractive to trial sponsors. Dr Tassignon identified current challenges for European investigators as collaborating across borders as the EU expands and maintaining competitiveness with the Far East. Nermeen Varawalla (VP Corporate Development, PRA International, UK) focused on clinical trials in Asia, particularly India.
The FDA and EMEA have accepted trial data gathered in Asia, and recent FDA audits in India, Taiwan and Hong Kong have raised no concerns. Timelines need to be improved, however, with regulatory approval for clinical trials taking up to 12 weeks in India, approximately 8 weeks in Taiwan and Singapore, and up to 9 months in China, although FDA IND approval can speed up these procedures. Dr Varawalla proposed a late-stage trial design whereby enrollment is divided equally between North America, Western Europe and Asia; the trial is initiated in the US and the data management is conducted in India.
A comparison of compassionate use programs
Rosanna Melchior (Thomson Scientific, France) provided a useful summary of programs designed to give patients with life-threatening illnesses access to investigational drugs where no other satisfactory treatment is available. In Europe, compassionate use programs cover named patients or small groups under national directive 2001/83/EC and under EU directive 726/2004. However, each member state has its own processes and these vary widely, although adverse events must always be reported. Member states review applications from physicians take into account any Committee for Medicinal Products for Human Use (CHMP) opinions and report adverse events. Drugs supplied must be eligible for approval by the EMEA and in clinical trials or awaiting approval. Industry sponsors must guarantee access to the drug by the program beneficiaries until it is launched.
Claire Veryard, Deputy Managing Editor (Drug Information Quality), Thomson Scientific.
Thomson Scientific's Drug Information Meetings team is responsible for one of the fastest, most comprehensive conference reporting services to the pharmaceutical industry. The principal role of the team is to publish time-sensitive, quality reports from meetings of pertinence to Thomson Pharma customers. This involves providing coverage from 250 to 300 meetings each year, publishing around 500 reports annually. Make better decisions faster with cutting-edge solutions for the pharmaceutical and chemistry markets. Go to: www.thomsonpharma.com .