Clinical Trials

In clinical practice, it has become the norm to use the latest antitumor drugs that show very effective results in the treatment of cancer patients. According to generally accepted rules, new drugs before their official registration can only be made available to patients through clinical trials. That is why clinical trials are an integral part in the development of the latest innovative medicines. Absolutely all clinical trials are conducted in compliance with special international rules – GCP (Good Clinical Practice). Adherence to these rules serves as a guarantee that the rights of patients who participate in trials are protected and their results are reliable.

Before a drug is allowed into clinical trials, it is always preceded by a process of study in laboratories in test tubes, or on laboratory animals. If the preclinical studies show positive safety and efficacy results, the drug is allowed to enter the clinical trials phase.

Clinical trials take place in several phases.

The study protocol describes the detailed study design. It specifies the duration of the study, the criteria for inclusion and exclusion of participants, and the schedule for taking medications. The protocol must include a list and schedule of examinations and tests that the patient must undergo and pass. In order for the trial to begin, the protocol must first undergo ethical review and receive approval from the Ministry of Health Russian Federation, where the Ethics Council oversees the safety of patients who participate in the trial throughout its duration. During the course of the study, all changes in the protocol and in the documents that are intended for patients are agreed with the Ethics Committee.

To become a participant in a clinical trial, the patient must familiarize themselves with all aspects of the process. If they agree, they will sign an “Informed Consent Form” and the physician will enroll them in the study. During the entire study, patients must strictly follow the prescribed protocols: they must come to the clinic regularly, at strictly scheduled times, for tests, examinations and check-ups by the doctor. This is necessary for a more effective and safe evaluation of the new drug. The doctor sets the algorithm of visits necessary for treatment, which is necessarily recorded in the study protocol. The schedule of visits to the doctor and all procedures and examinations performed are described in the informed consent. By signing this document, the patient agrees to all proposed procedures and visit schedule.

Possible risks and benefits

Benefit: well-designed and conducted clinical trials for eligible patients can provide access to innovative medicines and treatments before they become widely available; receive high quality care at leading health care facilities during the study period; and help others by contributing to medical research.

Risks: There are risks associated with clinical trials that may require additional time and attention than usual treatment, including more frequent visits to the research center doctor, additional medications, staying at the center, keeping medication diaries, or complex medication regimens.

Also, the experimental treatment may not be effective for the participant, and side effects of the experimental treatment may occur. Before participating in the study, the patient should talk to their doctor to assess the potential risks and benefits of participation, but if you meet the eligibility criteria for the study, the patient should make the final decision to participate.