Regulatory Easing the


clinical trials I


ntended to transform how clinical trials are initiated, designed and run, the The Accelerating Clinical Trials in the EU (ACT EU) initiative is a key part of Europe’s big push to strengthen and simplify the process by which safe and effective medicines are brought to market. Its secondary goal of better integrating clinical research in the European health system could have a profound effect on drug developers and, ultimately, patients, but no worthwhile change comes without some difficulties.


pathway


As The Accelerating Clinical Trials in the EU launches two new advice pilots aimed to improve the quality of applications for clinical trials, in a further attempt to build a firmer foundation for the development of safe and effective medicines in Europe, Jim Banks explores how these will help researchers to navigate the technical and regulatory requirements of the new regime.


ACT EU, which is a joint initiative involving the European Medicines Agency (EMA), the European Commission and EU member states, is ultimately tasked with making the EU a competitive centre for innovative clinical research. According to recent research by IQVIA, the number of global clinical trials has increased by 38% over the past decade, but during the same period, the European Economic Area’s (EEA) share of clinical trials has halved. Clearly, ACT EU has a mountain to climb.


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Clinical Trials Insight / www.worldpharmaceuticals.net


raker/Shutterstock.com


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