What is a clinical trial?
Before a new medicine can be tested in a clinical trial, it must first be tested in the laboratory. This is done to make sure that it is safe to test the medicine in people. New medicines are typically tested in 4 phases:
Testing the safety of a new medicine in a small group of people – most often healthy people, but sometimes people with a certain disease. When the trial doctors and researchers are sure the medicine is well tolerated, it can go to phase 2.
Testing the new medicine in a larger group of people with a certain disease. In this phase, the medicine is often tested for a longer time than in phase 1. This is done to see if or how the medicine works – also known as the ‘efficacy’ of the medicine.
Testing the medicine in even larger groups of people with a certain disease. In this phase, the new medicine is compared with a standard medicine used for the disease, or with placebo. Placebo is a dummy medicine that looks, feels, or tastes like the trial medicine but does not have any medical ingredients.
Testing a medicine that has already been approved for use. Phase 4 trials include the largest group of people taking part. Phase 4 trials are also sometimes called post-marketing surveillance trials.
All clinical trials have a detailed plan for how the trial should be done – a kind of ‘recipe’ for the trial doctors. This plan is called the trial protocol.
The trial protocol describes:
• which people may take part in the trial
• how people that take part will be treated and looked after
• how long the trial will take
• how the results will be measured.
Before a trial can start, an independent ethics committee and the local government’s health authorities must approve the trial protocol.
Clinical trials will only take place, if there are more benefits than risks for the people taking part. There must also be a scientific and medical reason for the trial.
Important information regarding LEO Pharma Clinical Trial Disclosure
Access to the site requires that you acknowledge and accept the following:
- The information on this website is provided solely to increase transparency of LEO Pharma clinical trials. It is not intended to promote any prescription, sale, or use, whether approved or off-label, of any medicinal product from LEO Pharma or from any other company.
- The documents on this site have been prepared in accordance with applicable ICH guidelines upon completion of the respective clinical trials. Except edits necessary for the protection of commercially confidential information and those for the protection of personal data, the documents are in the same format as they were originally prepared for approvals from the regulatory authorities.
- The documents provided on this site contain data and results regarding approved and non-approved uses, formulations or treatment regimens. As data and results from clinical trials are of a scientific nature, you cannot rely on this information as a recommendation or advice regarding the use/non-use of any products or treatment options.
- The information is not intended to replace the advice of a healthcare professional. As a patient, you must always consult your doctor for further information and instructions.
- The information is not intended to be used by physicians for making prescribing decisions. If you are a physician, you should always refer to the specific authority-approved labelling information approved for the product in the country or region of the patient.