The speed of recruitment is not only relevant for the duration of a clinical study, but is also a major driver for total study costs. In particular in the area of dermatology, where studies are typically rather short, it may not only be faster, but it may even be more cost effective to activate a higher number of sites to lower the overall study costs by a shortening the duration.
Study Cost When it comes to the cost of a study, the expenses of labor and site fees are typical highest in countries in Western and Northern Europe, such as the UK still , Ireland, Sweden, Denmark and the Netherlands. Southern European costs for labor tend to be a bit lower, and the further east a study is conducted, the lower the costs of labor will typically be. The regulatory pathway for starting a study is important to consider, in particular when the date of First Patient In is a relevant corporate milestone for a sponsor.
In some European countries e. Next to study costs, start-up timelines and recruitment speed, some sponsors are interested in detailed exchange with regulatory bodies already in the early clinical development phase to ensure that a subsequent marketing authorization application addresses all relevant clinical development factors and leads to swift approval.
In this case it is good to choose a country whose regulatory authority is well recognized among the other EU authorities and with EMA. Investigator Motivation Finally, an absolutely critical factor for study success is the motivation of a site and Principal Investigator PI to participate in and actively contribute to a clinical trial. There are countries in Europe where sites and PIs are more eager to participate in a study compared to other countries, and it is wise to choose a region where PIs and sites are generally very motivated to take part in research.
In contrast, under the current Clinical Trials Directive, national rules around the assessment and conduct of trials vary from one member state to another. The hope is that it will increase the efficiency of all trials in Europe, especially for those conducted across multiple member states, and foster innovation and research in the continent while helping avoid duplication of clinical trials or repetition of those that have been unsuccessful.
CTIS will contain the centralised EU portal and database, and when live, will be the single EU entry point for clinical trial applications. It will enable trial sponsors to apply for a clinical trial in all countries of the European Economic Area EEA with a single application rather than having to apply separately in every country.
This one-and-done application will include the submission to national competent authorities and to the ethics committees for all involved countries. The authorisation and oversight of clinical trials will remain the responsibility of member states but the EMA will set up and manage CTIS in collaboration with the member states and the EC. The centralised system will allow all clinical trial stakeholders including sponsors, researchers and national competent authorities to collaborate and communicate across borders, hopefully leading to better outcomes and knowledge-sharing.
The CTIS will also be a boon for patient recruitment to trials by allowing sponsors and researchers to easily expand trials to sites in other EEA countries. The European portal will contain detailed information on all clinical trials conducted in the EU and their outcomes throughout their lifecycle, thus improving transparency and access to information for patients, healthcare workers and researchers. The latter also saves the significant waste of financial and human resources as well disruptions to developmental timelines — all caused by the lack of patients for clinical trials.
Regulatory environment that provides for transparent and predictable regulatory processes and start-up timelines is crucial for successful clinical research. Part of European Union countries like Hungary, Romania and others adhere to EMA European Medicines Agency regulations, which allows them to have simplified approval procedures and a more predictable, 55—60 day timeline. However, a number of countries like Russia, Serbia, Ukraine, and Turkey have internal standards of their own. Another complex issue is study start-up SSU , with one of its major risks being the lack of trained local staff acquainted with procedures and involved in the process.
As mentioned above, patients in CEE countries benefit greatly by participating in medical research. Nevertheless, they are not the only motivated stakeholders in this process. Researchers and investigators consider clinical trials as a unique opportunity to advance their careers through working with cutting-edge medicine and therapy. Access to new treatment gives them also international experience in certain areas of medical science.
This high stakeholder motivation results in procedural and regulatory compliance better in CEE countries than in Western Europe, the USA and the rest of the world according to FDA site inspection reports. These inspections found fewer issues with record keeping and protocol compliance, as well as with documents and procedures of informed consent. Thus, benefits of adherence when conducting clinical studies in Europe outweighs whatever additional costs, such as translation of trial materials and protocols to local languages, and any study-specific training.
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