A clinical trial is any study conducted in humans in order to discover or verify the clinical, pharmacological, including pharmacodynamic, effects of one or more investigational medicinal products, or to identify any adverse reactions to one or more investigational medicinal products, or to study the absorption, distribution, metabolism and excretion of one or more investigational medicinal products, with a view to ascertaining their safety and efficacy. (Article 2(2) of the Polish Pharmaceutical Law Act, Journal of Laws (Dz.U.) 2008 No. 45, item 271, as amended)
Studies of new medicines conducted with patients aim to determine the safety and efficacy of new therapies, as well as to test new methods of preventing particular diseases.
Over recent decades, thanks to clinical trials of many new medicines and therapies, we have seen progress in the treatment of diseases that until recently were considered incurable.
In clinical trials, the rights and safety of patients are paramount, which is why trials must be conducted in accordance with the Good Clinical Practice (GCP) guidelines.
Principles of Good Clinical Practice (GCP):
- Clinical trials should be conducted in accordance with ethical principles that have their origin in the 1964 Declaration of Helsinki, as amended, on the “Ethical principles for medical research involving human subjects”, and that are consistent with ICH GCP and applicable legal regulations.
- Before a clinical trial is started, the risks and inconveniences should be objectively weighed against the anticipated benefit for the participant. A trial may only be started if the potential benefits for the patient outweigh the associated risks.
- The rights, safety and well-being of the trial participant are paramount.
- The results of preclinical studies, as well as the results of earlier clinical trials with the investigational medicinal product, should justify the proposed clinical trial.
- Clinical trials must have a significant scientific purpose and be described in a clear and detailed protocol.
- A clinical trial should be conducted in accordance with a protocol that has previously been approved by the Bioethics Committee.
- A clinical trial may only be conducted by persons trained in scientific work and under the supervision of a physician with clinical experience.
- Staff involved in a clinical trial should be appropriately qualified, i.e. have the education, training and experience necessary to perform the tasks assigned to them in the trial.
- Before a patient is enrolled in a clinical trial, their voluntary written consent is absolutely essential.
- All information relating to the clinical trial should be properly recorded, processed and stored in a way that allows it to be accurately reported, interpreted and verified.
- The confidentiality of trial participants’ personal data must be respected in accordance with applicable law.
- The investigational medicinal product should be manufactured, transported and stored in accordance with the principles of Good Manufacturing Practice (GMP).
- Procedures that guarantee the highest quality of the trial should be implemented in every trial.