Clinical Trials in Lithuania – An Attractive Option for Study Placement
University Santariskiu clinics in the heart of life sciences valley
The first industry sponsored clinical trials in Lithuania were started in 1992. During 20 years the clinical research environment has undergone substantial development – in terms of regulatory environment, volume of studies, presence of pharmaceutical industry sponsors and CROs. An important boost for the activity in clinical trials area was the EU accession in 2004 which by the same has integrated the EU clinical trial directive as a part of the national legislation. Currently Lithuania provides an attractive option for study placement due to the rapid regulatory framework of clinical trial approval processes, the motivated investigational sites and the availability of the necessary patient’s populations.
The clinical trial authorization is given in parallel by the State medicines control agency (SMCA, http://www.vvkt.lt/index.php?3176223757) and the Lithuanian bioethics committee (http://bioetika.sam.lt/index.php?-1073108465) and according to the law should be granted within 60 days. However practice shows, that approval frequently may be obtained within 6-7 weeks’ timeframe. SMCA inspectors are trained at European Medicines Agency and regularly perform inspections of GCP compliance at the sites to assure the quality.
The Lithuanian medical community considers clinical trials as an important area allowing early access to innovative medicines. Clinical research sites are also motivated to take part in trials since such participation allows to develop the knowledge in up to date health care technologies and expertize in scientific methodology. Local biotech industry forms innovation clusters together with university clinics and by doing so further foster the favorable environment.
A special characteristic of the health care system in Lithuania is the presence of centralized institutions, to which patients are transferred from surrounding regions for specialized care. This allows to have qualified and skilled investigators who have access to a large pool of patients. According to the number of protocols submitted for trial authorization by therapeutic area, all therapeutic areas are covered. By number of protocols the leading disease areas under investigation are oncology and hematology, but also endocrinology, cardiology and rheumatology, according to SMCA data from 2011.
Overall 96 protocols received the regulatory approvals in 2011. All research phases from 1 till 4 are represented, however predominately phase 3 trials. In May of 2011 there were 712 active research sites in Lithuania and around 80 sponsors totally where granted the authorizations to conduct clinical trials (SMCA data. Agency webpage accessed on May 16, 2012). This represents a substantial reduction comparing to peak year in 2008, when totally 123 protocols were authorized, and demonstrates that saturation of research activities in Lithuania is not yet achieved (Fig. 2.).
Fig. 2. Number of authorized new protocols annually in Lithuania. SMCA data, 2004 – 2011
Article prepared by:
A. Bacevicius, MD, Clinical Research Director, MSD,email@example.com;
L.Kaletinas, Director, Innovative Pharmaceutical Industry Association (IFPA), firstname.lastname@example.org;
D. Matulis, PhD, Department of Biothermodynamics and Drug Design, Institute of Biotechnology, Vilnius University,email@example.com,