Pharmaceutical Executive Europe - November/December 2007 - (Page 42) 42 Clinical Research Nov/Dec 2007 Pharmaceutical Executive Europe A New Europe for CROs Alan Morgan offers an overview of Europe’s changing CRO landscape. T he CRO industry in Europe is predicted to grow by approximately 15–20% over the next 5 years. This is partly because of the underlying growth in drug development, which is expected to increase by 10–12% over the next 5 years, and partly because of the increasing use of outsourcing by pharmaceutical and biotech companies, which is expected to add a further 5–7% of growth. Under the current business paradigm, there is more competition for qualified staff, a situation compounded by the shift towards Eastern Europe as a major region for conducting clinical trials. The challenge is to identify and retain qualified personnel or to recruit and train less qualified staff intensively. CROs therefore have to adapt their business models to cope with this changing environment. Increases in staff costs have to be mitigated by improvements in productivity for CROs to remain competitive. motivated investigators as the intensity of competition increases. There are still ‘new’ countries to consider, such as Kazakhstan and Belarus, where the rate-limiting factor in developing clinical trials is the lack of proven ICH-GCP-qualified investigators. Securing contractual agreements with investigators has become more difficult over the last three years as CROs seek to balance the requirements of the sponsor company with the growing autonomy of the larger and more complex investigator sites. Typically, obtaining agreement on investigator contracts can be a barrier to trial start-up in many countries. The UK has pioneered the use of a tripartite clinical trial agreement between the sponsor company, the National Health Service Trust site and the managing CRO, which is a good model for use in other countries to reduce this bottleneck. Increased productivity Increased complexity The management of clinical trials is becoming more complex, with more multinational studies involving several countries being conducted. Five years ago, sponsor companies were comfortable with CROs sub-contracting work to specialist CROs that had particular country-specific experience. Today, however, sponsor companies are increasingly looking for CROs with a pan-European presence so that they can effectively and efficiently manage multinational studies in-house. This increased complexity will be a driver for company mergers in the CRO industry, which will be composed of fewer, larger companies with the advantages of manpower and expertise to conduct pan-European studies. The growth in regulatory requirements governing the conduct of clinical trials, both from individual countries and the EMEA, is also increasing the complexity of clinical trial management. CROs need to mitigate these pressures by driving the expected yearon-year growth with increased productivity in terms of improved working practices and procedures. The identification of productive clinical trial sites is a key factor to ensure optimal recruitment of patients. The use of EDC is becoming more widespread and this, together with the better use of interactive technologies (IVR, IWR), is helping to increase productivity. Although many CROs have developed appropriate data-capture techniques using EDC, few have made much progress in adapting trial monitoring processes to maximise the advantages of EDC, which provides plenty of scope for improvement. Adaptive clinical trial design is being widely discussed by CROs and sponsor companies as a mechanism for increasing productivity. However, current regulatory guidance means that few sponsors are pioneering an adaptive approach. Summary Increased competition In certain therapy areas, such as oncology, CNS and diabetes, CROs and sponsor companies are competing for the ‘best’ investigator sites; that is, those with investigators who have a proven track record in conducting clinical trials, a predictable availability of suitable patients and few competing trials. In virtually all therapy areas, Eastern Europe is becoming a more important contributor to the European landscape. Historically, cost savings were considered the drive for moving East, but nowadays the cost-per-patient of conducting clinical trials in Eastern Europe is converging with that in Western Europe. The principal driver for the move into Eastern Europe now is the availability of treatment-naïve patients for trial recruitment and the availability of qualified and The CRO landscape in Europe is undergoing a number of changes due to the rapid expansion of the industry and the move into Eastern Europe. CROs will have to change their working practices in order to adapt and survive in this changing landscape. Crucial to this survival will be increased productivity and greater use of EDC, IVR and adaptive clinical trial design. ■ About the Author Alan Morgan is president, ICON Clinical Research, Europe. He is a graduate of the City University Business School in London and a Fellow of the Chartered Association of Certified Accountants.
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