title: Clinical trials with … drugs? Based on 2 projects in Alzheimer's disease and malaria.
abstract: The biomedical research act (BRA) regulates clinical research in humans, but not that related to clinical trials with medicinal products. This article describes the scientific and regulatory foundations supporting 2 projects which could be observed as clinical trials, can follow the BRA requirements. One is a positron emission tomography study with radiopharmaceutical to determine the presence of amyloid-β protein deposition in certain areas of the brain of cognitively healthy adults. The other is a study on controlled malaria infection in healthy volunteers using the inoculation of aseptic, purified and cryopreserved Plasmodium falciparum sporozoites. Since in both studies subjects undergo invasive procedures, the BRA requires the approval of the study by the relevant regional health authorities. These 2 studies have been the first ones that have used this regulatory procedure in Catalonia.
authors: Programa de Investigación Clínica, Fundació Pasqual Maragall, Barcelona, Spain. rdal-re@fpmaragll.org
authors: R
authors: R
authors: Dal-Ré
authors: X
authors: X
authors: Carné
mesh_terms: D000544:Alzheimer Disease / Q000188:drug therapy*; D000962:Antimalarials / Q000627:therapeutic use; D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence*; D006801:Humans; D016778:Malaria, Falciparum / Q000188:drug therapy*; D013030:Spain
chemical_list: D000962:Antimalarials