Clinical trials are scientific studies that aim is to find better ways for treatment and prevent certain diseases. All drugs enter in clinical practice after extensive researches. With proven benefit with minimal risks and harm to patients, medicines are moving to clinical development. In clinical trials are used new treatments or new methods of applying already known treatments.
Clinical studies runs in 4 phases:
Phase I for a small group of participants, aiming to establish a safe dose and how to administer it;
Phase II aims to improve efficiency and identify side effects in a wider range of participants;
Phase III compares the new medication with already established treatments, covering the largest number of patients and centers;
Phase IV assessing long-term efficiency and safety.
When a patient is enrolled in a clinical trial, Informed Consent is provided, containing all the information needed for the patient. Sufficient time is given to the patient to read the Informed Consent and sign it by free will, while the patient has the right to refuse participating at any time. The Informed Consent describes the procedures to be followed, the schedule of visits, the benefits of the tested medication, the possible harms and inconveniences.
The participants get paid for their visits according to the protocol schedule, which is described in the Informed Consent, determined by the Sponsor, and usually includes and covers travelling costs, hotel nights or food costs.
Patients who meet the required protocol criteria and who are included in a study are given access to new, expensive treatments and strict health monitoring by highly qualified professionals.
Clinical trials are sponsored by pharmaceutical companies, manufacturers of medical equipment and devices, manufacturers of nutritional supplements or cosmetic products. Each study has a protocol that is strictly followed and patients who wish to participate must agree to the conditions laid down in it (strict medication intake, as well as regular visits in the appropriate centers for planned visits).
Clinical trial results are used to improve public health.