Current Practices of Non-Interventional Studies (NIS) in Russia

Nowadays, it is hard to imagine the work of an organization with no Big Data analytics tools.  Modern medicine and pharmaceuticals require regular monitoring of the therapeutic effect and safety of a drug, as well as evaluation of interactions with other drugs. Tracking information on the use of a drug in routine practice allows us to study the patterns of individual patient groups with various co-occurring diseases.

One way to get additional information about a drug is to organize a post-registration study. Post-registration studies can be interventional or non-interventional. Interventional refers to any drug prescribing regimen other than routine practice. Examples of active intervention in the routine course of treatment: strict criteria for selecting study subjects, randomization of patients, pre-purchase and dispensing of the drug to patients, special requirements for taking the drug (dosage, time of taking, duration of treatment), additional analyses. In this article, we will take a closer look at what non-interventional studies are.

In this article, we will take a closer look at what non-interventional studies (NIS) are and the specifics of conducting a NIS in the Russian Federation.

Non-interventional studies, or observational studies, are used to obtain data on efficacy and safety of a medicine in routine practice, and also to study marketing indicators (analysis of the target group of buyers, frequency of medicine purchases in comparison with competitors).

NIS can be either prospective or retrospective. In the first case, the tracking and evaluation of study endpoints take place in “real-time,” while in a retrospective study the data are collected from the available data on the use of the drug. Often NIS combines both retro- and prospective design, which allows to cover a wider range of data and obtain an objective picture of the use of the drug in routine practice.

Conducting a NIS in Russia requires a protocol and informed consent, but does not require permission from the Ministry of Health (approval of the Ethics Committee is sufficient). The protocol is usually less strict than in phase 1-4 trials. This is because the main goal of NIS is to study the properties of the medicine in routine practice with a large number of variables: the medicine is prescribed to patients of different age groups, with different comorbidities, and concomitant therapy. The data used for further analysis in the NIS are entered into the primary documentation. The required data are then entered into the Case Report Form (CRF) – electronically. Thanks to the gradual transition to electronic primary documentation, the process of transferring data from the primary documentation to the CRF is becoming simpler. Some institutions in the Russian Federation are already using electronic medical records.

Because the grant to researchers in non-interventional studies is less than in interventional Phase I-IV studies, and the amount of work is not too much reduced, the issue of motivating researchers is acute for the CRO and the Sponsor.X7 Research offers some solutions to ensure physician interest in participating in the study. Since reputation among physicians is extremely important in their environment, a good motivation could be to include researchers as co-authors of a paper on the NIS conducted. For researchers, this can be a major motivation to work even with a low grant. Also one of the most important resources for physicians is time, so researchers are more willing to participate in a study if they have data inputters on their team. If there are no data enterers at the research center, the possibility of outstaffing services should be discussed further with the Principal Investigator and the CRO. X7 Research offers some solutions to ensure physician interest in participating in the study. Since reputation among physicians is extremely important in their environment, a good motivation could be to include researchers as co-authors of a paper on the NIS conducted. For researchers, this can be a major motivation to work even with a low grant. Also one of the most important resources for physicians is time, so researchers are more willing to participate in a study if they have data inputters on their team. If there are no data enterers at the research center, the possibility of outstaffing services should be discussed further with the Principal Investigator and the CRO.   This not only helps the researchers save time but also increases the quality of the data input, as professional data enterers are familiar with the CRF structure and make fewer input errors.

NIS is conducted differently abroad. First, due to the wide access to registers, opportunities for retrospective studies increase. Second, due to the widespread use of electronic medical records, researchers spend less time entering data into the CRF. Third, in many Western countries, there is no mandatory signing of a paper informed consent by the patient and the doctor-researcher, which allows patients to participate in trials virtually without the participation of the doctor-researcher, for example, using an online questionnaire.

It is possible to increase the number of NIS in the Russian Federation by:

• Implementing electronic medical records (according to 2019 statistics, only 4% of medical institutions have switched to electronic document management)
• Implementation of registries and providing access to them both to research physicians and companies conducting NIS
• Moving toward the use of electronic informed consents.

The X7 team follows the development of this research segment in the Russian Federation. Over the last decade we have accumulated extensive experience in organizing post-registration research and are ready to offer a full range of services for successful NIS.