Clinical studies: why they are necessary
Clinical trials are a mandatory stage in the study of new or already known medicinal products that are registered for use. This stage is carried out in a clinical setting, that is, under the supervision of doctors in equipped hospitals.
To conduct clinical trials, it is necessary to obtain an official permission from the competent authorities for its medical use (registration certificate or trade license), which in turn is based on carefully verified positive data from preclinical trials (see the Preclinical study of a medicinal product).
Clinical trials in which new conditions for the use of registered medicinal products are studied (new indications, a new route of administration or new dosage forms) are considered as trial of a new medicinal product.
Documents for clinical trials
To conduct clinical trials of medicinal products, the applicant submits the following documents to the central executive authorities:
– the transmittal letter;
– the application for a clinical trial of a medicinal product;
– the protocol of the clinical trial of the medicinal product with all available amendments to it;
– the summary of the content (synopsis) of the protocol in Ukrainian language;
– the individual registration form (except for international clinical trials);
– the investigator’s brochure;
– the dossier of the studied medicinal product;
– the certificate of the batch of the investigational medicinal product that will be used for the clinical trial;
– the conclusion of the accredited laboratory of pharmaceutical analysis of the Quality Center for each batch that will be used for clinical trials;
– the mandate issued by a sponsor with clearly defined delegated authority if the clinical trial applicant is not a sponsor;
– the draft of informed consent and other written information to be provided to the patient;
– the information about the responsible investigator/researcher (Curriculum vitae, hereinafter referred to as the CV), which must contain the following information: name and surname, year of birth, education, place of work, position, work experience, scientific degree, scientific works, experience of participation in clinical trials.
Terms of clinical studies
The documents (materials) of the clinical trial are subject to examination at the Center with the obligatory consideration of the moral and legal aspects of the clinical trial after they are received by the Center in full. The term for the examination by the Center is no more than 47 calendar days.
The time required for their preparation is not included in the examination period. If the applicant does not provide the Center with additional materials or letters justifying the terms necessary for their completion within 60 calendar days, the clinical trial materials are removed from consideration.
The Center notifies the applicant of the decision taken in written form. In this case, the cost of expert work is not returned to the applicant. In the future, at the applicant’s request, the materials are submitted to obtain the opinion of the Center in the established order.