Once the clinical trial is over, the results of the study are analyzed and then published. This takes time. The period between the end of the clinical trial and the publication of the results is the post-trial period. What does…
While screening is primarily concerned with easily defined inclusion and exclusion criteria and your general health, this stage involves a more thorough examination because not all inclusion and exclusion criteria can be assessed by questions. The tests and examinations performed…
If you are interested in participating in a particular clinical trial, the first step is screening. Pre-screening takes place during a face-to-face, telephone or online contact. The goal is to verify your eligibility in principle for the study by answering…
This phase is also known as post-marketing surveillance: it concerns the monitoring of authorized drugs after they have been placed on the market. Phase IV studies are conducted to gather additional information on the long-term safety and efficacy of the…
Phase III studies are only conducted when the results of Phase II studies, the exploratory therapeutic studies, have shown that the new drug is safe and can be effective in a sample of patients. Phase III studies are also called…
Phase II studies can only begin once all Phase I studies have been completed. Phase II studies are so-called exploratory therapeutic studies that test the drug candidate in patients, i.e. participants suffering from the disease for which the drug is…
Before Phase I studies can begin, the drug candidate has been thoroughly and extensively tested in the laboratory and in animals in so-called non-clinical studies. Phase I studies test the drug on humans for the first time; therefore, this phase…
In the preclinical phase, preclinical or non-clinical studies take place. They study the chemical and pharmaceutical properties of promising molecules (drug candidates) and their possible toxic and carcinogenic properties. This is done at first in vitro, in test tubes or…
What is the informed consent form (ICF)? Informed consent is like getting a clear, no-surprises roadmap before participating in a trial. It's a process designed to make sure you fully understand what's involved in a clinical trial before you decide…
Understanding Phase 1 Clinical Trials: The Role of Healthy Volunteers For those considering participating in clinical research, it's important to understand the unique and crucial role that healthy volunteers play, particularly in Phase 1 clinical trials. These initial stages of…