Pharmacological Research in Humans

The main objective is to perform clinical drug trials or clinical research with the assurance of compliance with the legal, ethical, and methodological requirements stated in international standards. Clinical trials (phase I): Activity is focused on the evaluation of systemic and local tolerability, pharmacokinetics, bioavailability, bioequivalence (generics), and pharmacological effects. Studies are also performed in healthy volunteers and special populations with specific characteristics, such as the healthy elderly, obese people, postmenopausal women, or people with renal or hepatic insufficiency. Clinical trials (phases Ib, IIa): Specific interventions are performed in this phase, and controlled monitoring of the patient’s response is required. Furthermore, support from the integration of administrative, computer, and statistical systems enables optimal performance of clinical studies.

Principals línies de recerca

• Phase I clinical trials (healthy volunteers) whose main objectives include first-time-in-humans, safety and tolerability, pharmacokinetics, bioavailability and bioequivalence (generic drugs), pharmacodynamics, interactions (drug-drug, drug-food), evaluation and characterization of biomarkers, proofs of concept, acceptability, and preference studies (Coimbra Hurtado, Maria Jimena; Molina Perello, Pol).
• Follow-up studies in populations with the same or different characteristics: the elderly, obese volunteers, postmenopausal volunteers, patients with liver or kidney failure (Puntes Rodriguez, Montserrat).
• Collaboration with clinical services to conduct phase II or phase III studies (Garrido Sanchez, Maria Teresa).

Scientific Challenges

• Consolidate and strengthen leadership in this field in Spain, conserve relationships with the pharmaceutical industry on a national level, and strengthen and extend relations abroad with multinational enterprises and industries from other sectors.
• Broaden the range of questions to address in research projects.
• Promote dissemination of our activity with a double objective: to return the knowledge generated to society and to demystify research in humans, bringing it closer to the community to foster participation in clinical trials (particularly in specific sectors of the population, such as the elderly).
• Set up educational activities related to the two main research lines, i.e., the application of good clinical practices (GCPs) in clinical research (pathology and treatment) and social (quality of life, prevention of accident risk) consequences.

Contacte

Rosa Maria Antonijoan
rantonijoana@santpau.cat