Clinical Testing Group for New Methods of Diagnosis, Treatment and Prevention

 

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Ekaterina Smirnova
Head of the Group

Objective

To provide organizational and methodological management of clinical testing protocols for new methods of prevention, diagnosis, treatment and rehabilitation.

General definition of clinical testing

Clinical testing of methods for prevention, diagnosis, treatment and rehabilitation is a practical application of developed and previously unused methods of prevention, diagnosis, treatment and rehabilitation in the provision of medical care to confirm their effectiveness.

Clinical testing can be completed for a method that has evidence of effectiveness and safety in accordance with the principles of evidence-based medicine.

Funding of clinical testing protocols

Clinical trials are funded from the federal budget, funds of organizations that have obtained the approval to organize the clinical trial in accordance with the clinical trial agreement, other sources permitted by laws of the Russian Federation. Clinical testing is funded only from the federal budget.

Choosing a method for clinical testing protocol

The chosen comparison method should be comparable to the method proposed for clinical testing and be used in current clinical practice for the disease / condition specified in the clinical testing protocol.

Choosing drugs and medical devices for clinical testing

Clinical testing involves the use of drugs and / or medical devices registered in the established manner in the Russian Federation. Drugs and / or medical devices are used for clinical testing in accordance with the package insert, user instructions or manuals for medical devices.

Reports on the implementation of protocols for clinical testing of methods of prevention, diagnosis, treatment and rehabilitation

Upon completion of clinical testing, the federal medical facility should prepare and send to the Ministry and the Expert Council a report on the implementation of the clinical testing protocol with the enclosed algorithm for assessing the clinical and economic effectiveness of the tested method of prevention, diagnosis, treatment and rehabilitation according to the recommended form prescribed by the appendix to Order of the Russian Ministry of Health No. 433n dated 10.07.2015.