Clinical trials are conducted to discover or verify the clinical and pharmacological effects of investigational medicinal products, to identify adverse reactions to investigational medicinal products and/or to investigate their absorption, distribution within the organism, metabolism and elimination from the organism.
The sponsor of a clinical trial may be a person, company or institution that takes responsibility for the conduct and/or funding of the clinical trial.
Prior to initiation of clinical research, the sponsor must receive authorisation from the State Agency of Medicines and Ethics Committee for the conduct of a clinical trial in Latvia.
The State Agency of Medicines ensures evaluation of clinical research documentation, authorisation of clinical trials and their monitoring during clinical research, as well as evaluation of compliance with the principles of Good Clinical Practice.
The conduct of clinical trials in the Republic of Latvia is regulated by the Cabinet of Ministers Regulation No. 289 of 23 March 2010 “Regulations Regarding the Procedures for Conduct of Clinical Trials and Non-interventional Trials of Medicinal Products, Labelling of Investigational Medicinal Products and the Procedures for Assessment of Conformity of Clinical Trial of Medicinal Products with the Requirements of Good Clinical Practice”.
Cooperation between investigators and family physicians or treating physicians of the trial subjects plays an important role in prevention of potential adverse reactions that may result from interaction of the investigational medicinal product with the medicinal products prescribed outside of the clinical trial setting.Concomitantly used food supplements, vitamins, micro-elements and medicinal herbal teas also play a substantial role in studies investigating medicinal product pharmacokinetics.
