The Legal Discipline of a Phase II/III Protocol
Phase II and III clinical trials are conducted on broad populations of patients, and it is at this stage that the principal data on a product's efficacy and safety are accumulated. Article 5¹ of the Law of Georgia on Drugs and Pharmaceutical Activities gives this process a clear frame: preclinical and clinical research into pharmacological agents in Georgia is conducted in accordance with the standards and guidelines approved by the relevant Minister. The protocol is the direct expression of these standards — every detail of it is calculated for compliance.
For research conducted on patients the guarantee of participant protection is especially important: the rights of patients and healthy volunteers participating in clinical research are protected by the legislation of Georgia. Before the trial begins, the sponsor — the person, company, institution or organisation responsible for the initiation, management or funding of the research — secures insurance of the trial's risk for the duration of its conduct, reimbursing or compensating the participants' treatment costs.
Protocol Compliance and the Permit Regime
A phase II/III protocol must satisfy the Minister's standards in the design of the research, the collection of data and safety monitoring. The start of the trial is subject to a permit, and conducting it without one is punishable under Article 37² of the law. This means that disregarding even a single detail of the protocol that contradicts a requirement of the standards undermines the entire result of the research.
In practical terms the preparation of a phase II/III protocol proceeds along three lines: first, the scientific design, which contemplates participant groups that are statistically sufficient and ethically justified; second, the completeness of the documentation, so that each stage remains reconstructable; and third, the safety monitoring mechanism, which records in a timely manner every new effect identified among the patients. The harmonious combination of these three components is exactly what the Minister's standards demand.