What phase I is and who takes part
Phase I is the first use of a medicine in people. It looks at safety, tolerability, suitable doses, and how the substance is absorbed and eliminated. A small group takes part: as a rule, 20 to 100 people. More about the phases in “Clinical trial phases”.
Participants are healthy volunteers or patients. Healthy volunteers are chosen when the substance can be used safely in healthy people and their data are easier to interpret. If the medicine carries unacceptable risks for healthy people, the study is carried out in patients.
What the law says
The Law “On the Circulation of Medicines” (Article 38, Part 1) names among the purposes of clinical trials:
- establishing the safety of medicines for healthy volunteers and (or) their tolerability by healthy volunteers — except for such studies of medicines produced outside the Russian Federation (item 1);
- selecting optimal doses and schedules of vaccination with immunobiological medicines for healthy volunteers (item 2);
- assessing the preventive efficacy of immunobiological medicines for healthy volunteers (item 3).
Bioequivalence studies of generic medicines follow a separate procedure (Article 38, Part 2): they are conducted under the EAEU Rules in healthy volunteers except where the product poses an obvious threat to their health and such a study would be unethical (clause 27 of the Rules).
How to apply the exception for medicines made abroad needs to be established in advance. For a project with a foreign medicine, check the design with a regulatory specialist or a lawyer before choosing a site and preparing the package of documents: the answer decides whether a study in healthy volunteers is possible or patients are needed.
Whom you cannot involve
The law directly prohibits clinical trials involving orphans and children left without parental care, pregnant and breastfeeding women, military personnel, law-enforcement officers, persons serving a prison sentence and persons held in pre-trial detention. For some groups there are provisos, for example for medicines intended specifically for pregnant and breastfeeding women, subject to the conditions the law lists (Article 43, Part 6). This has to be reflected in the inclusion criteria.
What to prepare in advance
- Protocol and documents. The protocol, the investigator’s brochure, the patient information sheet and information on the investigators’ experience — this package goes to the Ethics Council for review (Article 39.1; Ministry of Health Order No. 586n).
- Insurance of participants. A compulsory life and health insurance contract is needed before participation starts; a copy of the contract with the maximum number of participants is attached to the permit application (Article 39, Part 2; Article 44).
- Ministry of Health permit. The expert review of the documents and the ethics review take no more than 25 working days (Article 39, Part 6); the time between the Ethics Council’s request and the applicant’s answer is not counted (Article 39.1, Part 4.2).
- Site and investigator. The investigator must have a matching specialty and at least three years of experience in clinical trial programmes (Article 40, Part 1). Under the EAEU GCP Rules the investigator has the time, qualified staff and material resources, including premises and equipment (clause 4.2), and provides the necessary care for adverse events (clause 4.3.2).
- Feasibility assessment. Check that the site can handle the required enrolment, the sampling schedule and the safety measures — feasibility assessment.
What next
How we work with phase I studies is on the page “Phase I studies”. If you have a protocol or synopsis, send it to us: we will assess feasibility.
Sources
- Federal Law No. 61-FZ of 12 April 2010 “On the Circulation of Medicines”: Article 38 (Parts 1, 2), Articles 39, 39.1, Article 40 (Part 1), Article 43 (Part 6), Article 44 — text on ConsultantPlus.
- EAEU Good Clinical Practice Rules — Council Decision No. 79 as restated by Decision No. 63: clauses 4.2, 4.3.2.
- EAEU Bioequivalence Rules — clauses 27, 31.
- Ministry of Health Order No. 586n of 31 October 2024.
Questions and answers
Are healthy volunteers always used in phase I?
No. It depends on the medicine and the aim. For many medicines healthy volunteers take part in phase I, but if a substance carries unacceptable risks for healthy people, as many anticancer agents do, the study is carried out in patients with the relevant disease.
Can phase I studies be run with medicines made abroad?
The law names studies of safety and tolerability in healthy volunteers with an exception: “except for such studies of medicines produced outside the Russian Federation” (Article 38, Part 1, item 1 of Law No. 61-FZ). How this provision applies to a particular medicine and design should be established with a regulatory specialist or a lawyer before planning.
Do participants have to be insured?
Yes. Participation in a trial is impossible without a compulsory life and health insurance contract for the participant (Article 44, Part 14 of Law No. 61-FZ). The contract is concluded by the organisation that obtained the permit to organise the trial.
This material is for information only and is not legal advice. The rules are cited as of the date of the last update; check the current versions of the documents before making decisions.
See also
Phase I clinical trials in Moscow
Phase I is the first use of a new medicine in humans. It studies safety, tolerability and how the medicine behaves in the body, and helps to find a suitable dose. A small group of healthy volunteers or patients usually takes part.
Learn morePhases of clinical trials: how Phases I, II, III and IV differ
Clinical trials of a new medicine go through four phases. Phase I studies safety and dose, Phase II studies efficacy and the dosing regimen, Phase III confirms the results in a large group, and Phase IV follows the medicine after registration.
Learn more
Regulatory framework: the rules for clinical trials and bioequivalence studies in Russia and the EAEU
Clinical trials in Russia are governed by Federal Law No. 61-FZ “On the Circulation of Medicines”, the Good Clinical Practice Rules and the Bioequivalence Rules of the Eurasian Economic Union (EAEU), and orders of the Ministry of Health. This page shows what each document contains and which open registers let you check a clinic.
Learn more