SummaryDrug R&D is costly, time-consuming, and has a low success rate. The costs exceed 1 billion USD. From the human Phase I trial on, the increase is exponential. In the EU, 60% of clinical trials applied for every year are sponsored by the pharmaceutical industry and 40% by other stakeholders, such as academics. It is no wonder, then, that the EU Clinical Trials Directive 2011/20/EC incented protest mainly from the academic and SME stakeholders. According to the EC, although the Directive brought about important improvements in the safety and ethical soundness of clinical trials and in the reliability of clinical trials data, on the other hand, it led to the fall of the number of applications by 25%. The costs have increased. The staff needs for industry sponsors to handle the clinical trial authorization process have doubled, with SMEs facing an even sharper increase. For noncommercial sponsors, the increase in administrative requirements has led to a 98% increase in administrative costs. Insurance fees have increased by 800% for industry sponsors. Although the EC is now about to ease the burdens, it is clear that significant resources would be required anyhow. The proper and time-conscious conduct of extended, multinational, cross-continental clinical studies requires sufficient high-quality staff, logistics, experience, and knowledge of different regulatory aspects, let alone a sound financial background. This can be handled only by the help of industry resources at the end. Trends and data underpinning this opinion will be demonstrated in the presentation.Disclosure of InterestNone declared. SummaryDrug R&D is costly, time-consuming, and has a low success rate. The costs exceed 1 billion USD. From the human Phase I trial on, the increase is exponential. In the EU, 60% of clinical trials applied for every year are sponsored by the pharmaceutical industry and 40% by other stakeholders, such as academics. It is no wonder, then, that the EU Clinical Trials Directive 2011/20/EC incented protest mainly from the academic and SME stakeholders. According to the EC, although the Directive brought about important improvements in the safety and ethical soundness of clinical trials and in the reliability of clinical trials data, on the other hand, it led to the fall of the number of applications by 25%. The costs have increased. The staff needs for industry sponsors to handle the clinical trial authorization process have doubled, with SMEs facing an even sharper increase. For noncommercial sponsors, the increase in administrative requirements has led to a 98% increase in administrative costs. Insurance fees have increased by 800% for industry sponsors. Although the EC is now about to ease the burdens, it is clear that significant resources would be required anyhow. The proper and time-conscious conduct of extended, multinational, cross-continental clinical studies requires sufficient high-quality staff, logistics, experience, and knowledge of different regulatory aspects, let alone a sound financial background. This can be handled only by the help of industry resources at the end. Trends and data underpinning this opinion will be demonstrated in the presentation. Drug R&D is costly, time-consuming, and has a low success rate. The costs exceed 1 billion USD. From the human Phase I trial on, the increase is exponential. In the EU, 60% of clinical trials applied for every year are sponsored by the pharmaceutical industry and 40% by other stakeholders, such as academics. It is no wonder, then, that the EU Clinical Trials Directive 2011/20/EC incented protest mainly from the academic and SME stakeholders. According to the EC, although the Directive brought about important improvements in the safety and ethical soundness of clinical trials and in the reliability of clinical trials data, on the other hand, it led to the fall of the number of applications by 25%. The costs have increased. The staff needs for industry sponsors to handle the clinical trial authorization process have doubled, with SMEs facing an even sharper increase. For noncommercial sponsors, the increase in administrative requirements has led to a 98% increase in administrative costs. Insurance fees have increased by 800% for industry sponsors. Although the EC is now about to ease the burdens, it is clear that significant resources would be required anyhow. The proper and time-conscious conduct of extended, multinational, cross-continental clinical studies requires sufficient high-quality staff, logistics, experience, and knowledge of different regulatory aspects, let alone a sound financial background. This can be handled only by the help of industry resources at the end. Trends and data underpinning this opinion will be demonstrated in the presentation. Disclosure of InterestNone declared. None declared.