Patients worldwide constantly expect new, effective and safe therapies. Access to modern drugs would not be possible without clinical trials – a significant element of the drug marketing authorization process.
Clinical trial and post-market trials are the foundation of contemporary medical science and “pivotal” in the drug development process. They are a pre-condition of patients’ access to modern therapies and they are essential for the sale of a treatment on the market, while simultaneously greatly contributing to the medical community’s professional knowledge.
The Changing Landscape in Europe
The European Union community is preparing for the implementation of Clinical Trial Regulation No. 536/2014 of the European Parliament and EU Council on clinical trials of medicinal products for human use. The Regulation, which is to become applicable most likely in 2019, will significantly change the existing procedures for clinical trial authorization. There will be a major change on how clinical trial applications are submitted and how clinical trials are conducted in the EU as it looks to harmonize the rules on clinical trials across Member States and increase patient safety in trials.
Additionally, due to the increased complexity of new compounds and strict regulatory monitoring that led to the implementation of electronic data handling technologies in clinical trials (such as data capturing programs and other computerized systems), the ICH GCP E6 (R2) guidelines took effect in June 2017. These guidelines represent the most important revision in the past 20 years requiring Sponsors to implement a more risk-based approach and find a way of being more targeted in their on-site monitoring activities.
What does the snapshot of drug development look like in Europe at the moment?
According to the European Medicines Agency, the European Union’s regulatory body, in the European Economic Area (EEA), approximately 4,000 clinical trials are authorized each year – this equals roughly 8,000 clinical trial applications involving, on average, at least two Member States. Approximately 61% of clinical trials are sponsored by the pharmaceutical industry and 39% by non-commercial sponsors, mainly academia.
The current number of active and recruiting clinical and post market trials in all 34 EU countries is around 39,000 and France, Germany, UK, Spain, and Italy provide together 50% of the clinical trials being carried out on the continent. France is the absolute leader with more than 6,000 clinical trials (and it is also on the first step of the podium regarding patient recruitment efficiency), followed by Germany with over 4,100 and UK with over 3,900.
The Italian pharmaceutical industry is currently second in Europe for production volume after Germany and the country ranks 5th in Europe.
Moving on the eastern part of the continent, there is no doubt that the quality and speed of conducting clinical research has grown in the past years. Poland hosts about 1,500 clinical trials and, together with Hungary, Greece, Romania, and Bulgaria, they total 10% of the clinical trials in Europe. The Eastern European region (CEE) was repeatedly subject to audits by the U.S. regulatory agency, FDA (Food and Drug Administration), and based on its audits carried out around the world and industry reports, the quality of research is best in the CEE region.
How are Sponsors conducting these trials?
In the past, the majority of trials were performed in-house by the Sponsor. Only individual, specific activities were contracted to specialized outsourcing providers. However, in recent years, the number and scope of outsourced activities in the pharmaceutical industry in Europe have increased substantially in an effort to increase quality, reduce costs and comply with changing regulatory requirements.
This trend towards outsourcing was highlighted in a study by the Association of Research-Based Pharmaceutical Companies.
When asked if there is an increasing demand for outsourcing, 80% of respondents answered yes. The number one reason for this, according to 41% of respondents, was the focus on core competencies. Pharmaceutical company sponsors answered that they are also starting to outsource more because they are virtual (30%), while 14% said they lack the capabilities in-house. Major areas, previously taken on by the Sponsor, are starting to be carried out by outsourcing companies including Quality Management and Pharmacovigilance. The increased monitoring requirements, as outlined in guidelines such as ICH GCP E6(R2), will improve the quality of clinical research even further and push Sponsors to outsource tasks to specialized vendors.
This is the time for the industry to accelerate outsourcing activities and learn from the experience of other industries (like aerospace, automotive or high tech).
Outsourcing evolution does take time, and the sooner companies begin this journey the better.
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