Registry of EU academic Phase I trial sites

Phase I trials with drugs usually describe clinical trials without therapeutic intent, and accordingly do not provide a therapeutic benefit for the trial participants. This usually means that primarily safety and tolerance are analysed. In contrast, Phase II and II projects investigate the efficacy of drugs and the improvement of a disease expected during the study treatment.

In the context of drug repurposing approaches, Phase I trials without therapeutic intent imply different types of studies as the consequence of the application of the drug either in higher than approved doses, in patient populations that are expected to be more sensitive to the drug, or in combination with other drugs contraindicated by the label or potentially leading to exaggerated adverse effects, at least for one of the drugs.

Conducting Phase I trials requires expertise and capabilities that are different from trial sites addressing Phase I and III clinical trials, as they are frequently carried out in an in-patient setting, treating several subjects in parallel and performing highly standardized procedures, which require a different degree of quality assurance. As potential risk for trial participants -due to still unknown effects- is commonly regarded as higher, special cautionary measures are required, and these trials are more frequently subject to regulatory inspections by competent authorities. In this page, you will be able to browse our registry of European academic Phase I trial sites with the capabilities to conduct specialized Phase I trials for drug repurposing approaches.