Clinical trials: phases I–IV, GCP, safety and efficacy — Radeski Skin Clinic investigators.
What is a clinical trial?
A clinical trial (CT) is research involving people to evaluate efficacy and safety of a new drug or method, or to expand indications for existing treatments. New invasive and non-invasive therapies and diagnostics may also be studied.
Clinical examination methods
These include history taking, physical exam, palpation, percussion, and auscultation.
Types of research
Studies may be theoretical, theoretical-experimental, or experimental, depending on methods used.
Why clinical trials matter
They demonstrate safety and effectiveness and are required before market approval. Rigorous science protects both outcomes and participants.
Who conducts them?
Investigator physicians — qualified specialists responsible for proper conduct, enrollment, and participant safety.
Clinically proven
All human research aimed at evaluating safety and effectiveness of new or registered medical products.
Trial phases
| Phase | Focus | |-------|--------| | I | 20–80 subjects: safety, dosing, side effects | | II | Larger group with target condition | | III | Pivotal trials before approval | | IV | Post-marketing real-world monitoring |
Phase IV continues after the drug is available in pharmacies.
Radeski and GCP
Investigators at Radeski Skin & Aesthetic Clinic participating in trials hold GCP (Good Clinical Practice) certificates — the international standard for patient rights and data quality.
Related: Science, About, Services.
Are clinical trials safe?
Ethics review, informed consent, and GCP rules monitor participant safety.
Difference between phase I and IV?
Phase I — initial safety; phase IV — monitoring after the drug is on the market.
What is GCP?
Good Clinical Practice — the international quality standard for clinical research.