Is participation in clinical trials safe?
All clinical trials shall be carried out according to strict rules in compliance with the requirements exactly as described in the legislation of our country, and international regulations. In Poland, certain designated institutions are supervising the proper conduct of clinical trials (the President of the Office for Registration of Medicinal Products, Main Pharmaceutical Inspector, Patient’s Rights Ombudsman).
- Clinical trials are conducted in compliance with the ethical principles (including: The Declaration of Helsinki, 1964 as amended), in accordance with the standards of ICH GCP, and in accordance with the provisions of applicable law.
- The patient benefit resulting from her/his participation in the clinical trial should outweigh the risk associated with it.
- The safety and rights of the patient are the most important issues.
- Full information about the investigated drug should be made available to the investigator.
- The clinical research should have an important scientific goal and understandable, clear protocol.
- The clinical research should be carried out completely in accordance with the Protocol, approved by the Bioethics Committee.
- Medical care for the study participant should be exercised by qualified medical professionals.
- The staff performing the clinical trials must be suitably prepared and have adequate professional experience.
- It is required to obtain the patient’s informed consent to participate in the clinical trial before being enrolled in it.
- The data obtained must be properly recorded and stored in order to enable the report, conclusions, and verification of the data.
- Data confidentiality should be maintained, including the patients’ personal data.
- The investigated drug should be manufactured, delivered to a clinical research centre, and stored in accordance with GMP (Good Manufacturing Practice).
Procedures to ensure high quality should be implemented in all aspects of the clinical study.