Ukraine. Clinical Trials Market in Ukraine 2010

The history of clinical trials in Ukraine officially dates back to 1996, when the first regulatory permission to carry out multicenter international clinical trials was granted. In 1996, a department for clinical trials affairs was established at the State Pharmacological Center of Ukraine. Since then, there has been a trend of constant growth in the quantity of international multicenter CTs. Growth was slow in the period from 1998 to 2002, when 20 to 55 ultinational CTs were conducted in Ukraine a year, whereas since 2003, we have been experiencing a resurgence in growth – with 63 CTs held in 2006, 187 CTs in 2007 and 466 CTs in 2008. There has been a decrease in the growth in the quantity of CTs in Ukraine as a result of financial crisis, but the trend has not been completely halted. In 2008,
Ukraine was mentioned as one of the countries most involved in clinical trials with 150 approved IND trials.

The majority of CTs in Ukraine are phase III trials (66% of all CTs in Ukraine in 2006), with a smaller share of phase II trials (30%) and phase I and IV trials being in the minority (1% and 3% respectively). The majority of CTs in Ukraine are conducted in oncology – 23.87% (every fourth-to-fifth trial), followed by 20% in the cardiovascular field, with endocrine, nutritional, metabolic diseases in third place (10.32%); and mental and behavioral disorders in fourth place (9.03%).

The number of approved clinical bases in Ukraine, where CTs can be performed, has been growing steadily year-on-year with a slight decrease in the rate of growth in recent years: for instance, there were 175 bases for CTs in Ukraine in 2001 compared to 1,277 in 2007, 1,300 in 2008 and
1,308 in 2009. The majority of approved bases for CTs are located in the main cities of Ukraine with the highest population figures: Kiev (3.5 mln inhabitants), Kharkov (1.5 mln), Dnepropetrovsk (1 mln), Odessa (1 mln), Donetsk (<1 mln).

The performance of clinical studies in any country is based on three main criteria of feasibility: regulatory requirements, logistics and clinical feasibility. The legislative and regulatory base for CTs in Ukraine is as follows: Ukrainian Law No. 783-XIV “On medicines” (1996), orders of the Ministry of Health Nos. 281 and 347 (2000), No. 355 (2002), No. 66 (2006), No. 245 (2007), No. 43 (2007), No. 690 (2009), as well as the Order of the Cabinet of Ministers of Ukraine No. 1419 (2004). In particular, order No. 245 determines the “specialized medical and preventive treatment facilities in which clinical trials of medicines can be carried out”; No. 43 and 1419 determine that, starting from 2009, clinical trials and the application of medicines should be carried out in accordance with standards of GCP for the sector.

The State Pharmacological Center (SPC) of the Ministry of Health of Ukraine (pharmacenter.kiev.ua) governs clinical trials in the country. To initiate a clinical trial in Ukraine, the sponsor company must submit a set of documents to the SPC and the Central Ethics Committee (CEC) of the Ukrainian Ministry of Health. The documents to be submitted to the CEC are stipulated in Order No. 66 (2006).
The documents can be submitted in parallel, and, if the documents have been previously submitted to the State Pharmacological Committee and it has already made its decision, the copy of the SPC's decision should be submitted to the CEC. There are local ethics committees in many hospitals / institutions, but it is usually the Central Committee that grants approval for international multicenter trials.

It is also important to be aware of the feasibility of logistics, such as possibilities, processes and timelines for organizing import / export; customs procedures; the storage and distribution of clinical trial materials within a given country; and the local purchasing of clinical trial materials. There are offices of international courier companies which provide a full set of services, including ambient and frozen sample shipments and temperature-controlled shipments of investigational products. A brief

overview of the major logistics companies present in Ukraine and involved in the clinical trials market is provided below.

The Ukrainian office of TNT has a special department for clinical trials services and has been working on the CT market for over five years. It delivers biological samples to anywhere on Ukraine territory, as well as to European Central Laboratories, and provides complete consultations for customs documents (tnt.ua). They also perform the express delivery of biosamples for the main clinics and laboratories in Ukraine. At present, TNT is involved in more than 230 CT projects.

Source: www.centrallab.synevo.eu