Clinical pharmacology

Problem

New drugs require strict monitoring, both in the development process and when they are authorized, to understand their effectiveness and ensure their safe and rational use. This requires analysis, research and, thorough knowledge of the methodology of clinical trials, the quality of the data obtained, the regulatory strategies for authorizing drugs (and advanced therapies) and health care products, and continuous pharmacovigilance of authorized drugs.          

Approach

The clinical research group aims to contribute to the development of new advanced therapies, optimize the safe and rational use of drugs, and improve the quality of clinical trials to contribute to improving the quality of life of patients. It does this by analyzing the design of clinical trials, the ethical implications of research, the quality of the data, adverse reactions to drugs, and the efficacy parameters of the trials, and by studying the different regulatory strategies for authorizing the use of drugs and/or health care products.

Impact

Different studies carried out by the group have allowed for far better knowledge of the adverse effects of authorized drugs (such as the study of the adverse reactions observed in the SARS-CoV-2 vaccines) and of how to contribute to the development and regulation of new advanced-therapy drugs. In collaboration with other groups, authorization was recently obtained for the use of a CAR-T (ARI-0001) by the Spanish Drug and Medical Device Agency (AEMPS) for hemato-oncologic patients. And an exhaustive study of the quality of clinical research (evaluating multiple clinical trials) made it possible to analyze the evidence and the guarantees necessary to improve and optimize clinical research.