• Vk
  • LinkedIn
  • Youtube
X7 Research
  • News
  • Registration strategy and Сonsulting
    • Budgeting
    • Registration strategy development
    • Study feasibility
    • Vendor selection
    • Data search and analysis
  • Clinical trials
    • Outsourcing CRAs in Russia and the EAEU
    • Development of medical documentation and biostatistics
    • Monitoring
    • Data-management
    • Patient home visits
    • Bioequivalence study
    • Therapeutic equivalence studies
    • Clinical trials of medical devices
  • Registration
    • Audit of the registration dossier
    • Bringing the registration dossier in compliance with the requirements of the EAEU
    • Conversion of registration dossier into XML format
    • PIL readability user testing
    • Translation of the Registration dossier
    • Turnkey registration
  • Post-authorization clinical studies
    • Phase IV studies
    • Non-interventional studies
    • Investigator-initiated studies
    • Post-authorisation safety study
    • Marketing research
  • Pharmacovigilance
    • QPPV in the EAEU
    • Safety monitoring of medical devices
    • Building a pharmacovigilance system
    • Safety in clinical trials
    • Pharmacovigilance audit
    • Pharmacovigilance contact person
  • Therapeutic expertise
    • Clinical trials in Oncology in the EAEU
  • Contact
  • EnglishEnglish
  • Menu

Specifics of Clinical Trials of Radiopharmaceuticals in Russia

13.04.2021/in Publications /by Marketing

It is difficult to imagine modern medicine without radiological methods of diagnosis and treatment of patients. Almost every district clinic has equipment for radiological diagnostics. In many cities it is possible to have a CT scan when a quick and accurate diagnosis and localization of tissue lesions are required, but also for routine examinations, for example, before a brace system is installed.

Almost every district clinic has equipment for radiological diagnostics. In many cities, computed tomography can be performed when a quick and accurate diagnosis and localization of tissue lesions is required and for routine examinations, for example, before a brace system is placed.

Radiation therapy, also called radio- or radiation therapy, is no less developed. Radiotherapy is a treatment with ionizing radiation and is most commonly used in oncology to treat malignant tumors. The purpose of radiotherapy is to destroy the cells that make up a malignant tumor. This is achieved through the ability of ionizing radiation to damage the DNA of cancer cells, thereby stopping their uncontrolled reproduction.

There are three ways to treat a tumor in radiation therapy:

  1. Remote is the most commonly used method. With the remote method of action, healthy tissues may be located between the focus of action and its “target”, which entails many negative side effects.
  2. Contact is the radiation source is located in the immediate vicinity of the tumor: in the focus or in the space next to the tumor. This allows for fewer radiation sessions compared to the distant method, but this method of exposure is technically more complex.
  3. Radionuclide therapy – a radioactive nuclide as an independent agent or as part of a radiopharmaceutical  in the form of a solution is injected into the patient’s body orally, intravenously, or directly into the tumor.

In this article, we want to talk in detail about radionuclide therapy, its advantages, general criteria for the effectiveness of radiopharmaceuticals, and the peculiarities of clinical trials of radiopharmaceuticals.

Like chemotherapy, radionuclide therapy is a systemic treatment, meaning that the drug reaches the cells throughout the body with the bloodstream. However, unlike chemotherapy, these radioactive substances specifically target the malignant cells. In this way, the number of potential side effects is reduced. Only RFAs that are able to form a strong bond with the tumor, so-called carriers that have a high affinity for the tumor, are suitable for treatment. These agents can deliver targeted doses of radiation directly to tumors and their metastases, with minimal effect on healthy tissues and organs.

In general, the ideal radiopharmaceutical has the following properties:

  • reaches all malignant cells in all places where they are localized;
  • acts exclusively on the cells that make up a malignant tumor and metastases;
  • does not harm healthy tissues and organs, while delivering maximum doses of ionizing radiation to the malignant tumor;
  • eliminates cells of the malignant tumor with great effectiveness.

To register a radiopharmaceutical, of course, preclinical and clinical studies are required. There are a number of peculiarities.

On the one hand, preclinical and clinical studies of radiopharmaceuticals are similar to studies of drugs used for cancer chemotherapy:

  • Due to the high toxicity of both radiopharmaceuticals and chemotherapy, phase I studies are not conducted with healthy volunteers, but with patients suffering from the corresponding disease.
  • Studies of both radiopharmaceutical  s and other chemotherapy drugs are generally not placebo-controlled, since the use of placebos is unethical with respect to patients.

However, because radiopharmaceutical, unlike any other drugs, is radioactive, there are many peculiarities of both treating patients with radiopharmaceutical  s and conducting clinical trials of radiopharmaceuticals:

  • First of all, being radioactive, radiopharmaceuticals are so-called open sources, i.e., these drugs can have an impact on the environment, the patient, medical personnel, and personnel involved in the production of radiopharmaceutical s. This circumstance leads to the necessity of strict compliance with the requirements of the Federal Law “On Radiation Safety of the Population”.
  • Secondly, due to the detrimental effect of radiation on biological systems, of medical value are radionuclides with a relatively short half-life to ensure a short-term effect of radiation on the body. Thus, the production of radiopharmaceuticals must be:
    1. Very rapid and be carried out in relative proximity to the medical facility where the drug will be used on patients. For example, the production of the radiopharmaceutical can be organized on the premises of a medical radiological trial site.
    2. If the physical half-life is ultra-short, and if the radiopharmaceutical can be produced by simply combining the radionuclide with a non-radioactive carrier, the radiopharmaceutical can be produced shortly before administration to the patient by dividing production into several stages. In this case, production can be partially organized at a nuclear power plant (NPP), while the actual “combination” is performed by specialists in the laboratory of the medical institution where the radiopharmaceutical is to be administered to the patient.

Thus, clinical trials of radiopharmaceuticals are among the most difficult not only because of the nosology under study, but also because of a number of peculiarities of the radiopharmaceutical, which we have discussed in this article. A successful clinical trial of an radiopharmaceutical requires the coordinated work of medical personnel, radiopharmaceutical developers, and the contract research organization (CRO).

Tags: Radiopharmaceuticals
Share this entry
  • Share on Twitter
  • Share on WhatsApp
  • Share on Pinterest
  • Share on LinkedIn
  • Share on Tumblr
  • Share on Vk
  • Share on Reddit
  • Share by Mail

YOU MAY ALSO BE INTERESTED IN

Publications
Corrections to clinical trial documents due to COVID-19. Russian experience.
Read More
Publications
WHAT IS BIOEQUIVALENCE
Read More
Publications
THE VOLUME OF RUSSIAN PHARMACEUTICAL MARKET 2016-2019
Read More

RUBRICS

Registration strategy and Сonsulting

Clinical trials

Registration

Post-authorization clinical studies

Pharmacovigilance

LATEST PUBLICATIONS

  • Corrections to clinical trial documents due to COVID-19. Russian experience.
  • WHAT IS BIOEQUIVALENCE
  • THE VOLUME OF RUSSIAN PHARMACEUTICAL MARKET 2016-2019

Tags

bioequivalenceClinical trials in the CISfeasibilitymonitoringRadiopharmaceuticals

CONTACT

5 + 3 = ?

This contact form is deactivated because you refused to accept Google reCaptcha service which is necessary to validate any messages sent by the form.

PRIVACY

Use of this site constitutes your consent to our Privacy Policy.


SOCIAL RESPONSIBILITY

X7 Research’s primary responsibility is to help our clients in bringing medicines & products to the market efficiently and safely.

The Best CRO for Clinical Trials | Full-service Global CRO — X7 Research

The Best CRO in Pharma | Clinical Research Organisation — X7 Research

The Best Contract Research Organisation (CRO) | Trusted CRO — X7 Research

The Best Clinical Research Organisation (CRO): Full Service CRO | X7 Research

The Best CRO in Research | Trusted CRO for Your Trail — X7 Research

The Best Clinical Trial Company | Global Full-service CRO - X7 Research

The Best Pharma CROs: Clinical Trials for Drugs | X7 Research

The Best CROs Company: Clinical Trials with Global CRO — X7 Research

The Best Pre-clinical CRO: Safety Assessment With X7 Research

The Best Clinical Development | Trusted CRO for Your Product: X7 Research

The Best Biostatistical Consulting: Statistical Services | X7 Research

The Best Pharmacovigilance Consulting Services | CRO — X7 Research

Feasibility in Clinical Trials: What is a Feasibility in Clinical Trials?

Clinical Study Trials: What are Clinical Study Trials?

Category
Strategy and consulting
Clinical trials
Registration
Post-authorization clinical studies
Pharmacovigilance

Registration strategy and Сonsulting
Registration strategy development
Budgeting
Study feasibility
Vendor selection
Data search and analysis

Clinical trials
Development of medical documentation and biostatistics
Monitoring
Data management
Patient home visits
Bioequivalence study
Therapeutic equivalence studies

Registration
Audit of the registration dossier
Dossier eaeu
Conversion of registration dossier into xml format
Pil readability user testing
Turnkey registration

Post-authorization clinical studies
Phase iv studies
Non interventional studies
Investigator initiated studies
Post authorisation safety study
Marketing research

Pharmacovigilance
Building a pharmacovigilance system
Safety in clinical trials
Pharmacovigilance audit
Pharmacovigilance contact person

Blog
Contacts

© Copyright 2010-2023 - X7 Research. All rights reserved.
Clinical trials of vaccines in the EAEU Specifics of conducting pediatric clinical trials with children in Russia
Scroll to top