Clinical trials are carefully regulated scientific studies involving human participants that are conducted to evaluate the safety and effectiveness of new medicines, medical devices and treatment methods.
Before a new medicine, treatment or medical technology becomes available to patients, it must undergo a lengthy evaluation process. The first step is to assess its safety, followed by an evaluation of its effectiveness in treating a specific disease or condition.
Clinical trials are the foundation of modern medical progress. Every medicine available today has previously been tested in clinical trials.
What a Clinical Trial Is Not
Clinical trials are conducted in accordance with national and European regulations, as well as international ethical standards.
Without clinical trials, medical progress would not be possible. They are responsible for the development of hundreds of medicines, vaccines and therapies that have improved treatment outcomes for countless diseases.
determining whether a treatment can be safely used in humans and at what dose;
evaluating whether a new treatment works for a particular disease or condition;
identifying side effects and assessing how often they occur among participants.
Clinical trials are conducted in accordance with the principles of Good Clinical Practice (GCP) and applicable Polish and European legislation. The most important principle is that the well-being, rights and safety of participants always take precedence over the interests of science or society.
Clinical trials are also subject to inspections, audits and ongoing regulatory oversight.
Sponsored by pharmaceutical companies or medical device manufacturers. Their primary goal is the registration of a new medicine, a new therapeutic indication or a new medical technology.
Conducted by medical universities, research institutes or healthcare institutions. Their goal is to advance medical knowledge, optimise therapies and improve standards of care.
Both types of studies are subject to the same rigorous safety and oversight requirements.
assessment of safety, tolerability and appropriate dosage; conducted in a small group of participants under close medical supervision;
evaluation of effectiveness in patients with a specific disease and further assessment of safety; analysis of dose–response relationships;
confirmation of effectiveness and safety in a large patient population; positive results may support regulatory approval of the medicine;
post-marketing monitoring of medicines; continued assessment of safety and investigation of additional therapeutic indications.
Do you have a question about clinical trials? Contact the Clinical Research Support Centre team.
E-mail:
cwbk@gumed.edu.pl
Phone:
+48 58 349 90 24