Clinical trials approval process
International clinical trials are not considered to private initiative or commercial project. It the main component of national policy aimed at extending cooperation with regard to medicine and pharmacy. A great number of countries take part in such cooperation. For example, several countries, except for Ukraine, participate in oncological clinical trials. It is a high privilege for any hospital, and a country consequently, to satisfy worldwide standards for clinical trials conducting.
Several steps needed to be done before international clinical trial can start. Firstly, sponsor-company receives summary form investigative site. Summary includes information about site staff qualification, technical facilities, and standards of medical care. Received data undergo audit inspection at site.
An application for site inclusion into clinical trials is submitted to the Ministry of Health of Ukraine if hospital (site) corresponds to worldwide requirements, standards and confirmation about site selection is received. The application is processed by State Expert Center of the Ministry of Health of Ukraine. Sate Expert Center is the authorized expert institution in the field of preclinical trials and state registration of medical agents. The center examines documents of the medical institution: accreditation, license, equipment, staff qualification and then the decision is made concerning site participation in international clinical trials.
Local Ethical Committee (situated in hospital/clinic) also examines provided trial. Local Ethical Committee (LEC) – independent entity (at institutional, regional and state levels) responsible for subjects right protection and safety. Aim of the committee is to define how patients, participating in clinical trials, are protected. LEC also examines and gives approval of study protocol, methods and materials used for informed consent form signing process.
Permission for starting clinical trial and investigational drug import into Ukraine is prepared after positive conclusion received from Local Ethical Committee. We can proudly state that our Hospital (and site) receives invitation to all international oncological clinical trials. It is possibly due to highly-qualified doctors, pharmacists, nurses and medical attendants, study coordinates, translators, technical specialists and modern equipment.
