What is a Clinical Trial?
A clinical trial involves research using human volunteers (also called participants) that is intended to add to medical knowledge. In a clinical trial, participants receive specific treatments or undergo trial procedures according to a clinical trial protocol (plan). Clinical trials may compare a new medical approach to a standard one that is already available or to a placebo that contains no active ingredients. When a new product is being investigated, it is not usually known whether it will be helpful, harmful, or no different than available alternatives. The healthcare professionals responsible for conducting the trial try to determine the safety and efficacy of the treatments and trial procedures by measuring certain effects in the participants. For example, healthcare professionals may give a new drug to participants who have actinic keratosis to see whether their number of clinically visible lesions decreases. To ensure that new medicines are developed ethically, all of our clinical trials must be reviewed by a qualified panel known as an Independent Ethics Committee or Institutional Review Board.
Participating in a clinical trial
Participation in a clinical trial is voluntary. If you are participating in a clinical trial, you may withdraw from the trial for any reason at any time, without any penalty or loss of benefits to which you are otherwise entitled.
Before you decide whether to participate in a clinical trial, the healthcare professionals or responsible medical doctor must give you verbal and written information about the trial and the procedures involved. You will be fully informed of your rights and responsibilities while participating in the trial as well as possible disadvantages of being treated with the trial products.
The medical doctor must ensure you have ample time to come to a decision whether or not to participate in the trial. If you do decide to take part, you will be asked to sign a consent form.
Benefits and risks of participating in a clinical trial
Participating in a clinical trial contributes to medical knowledge. The results of clinical trials can make a difference in the care of future patients by providing information about the benefits and risks of treatments. Read more here about LEO Pharma’s mission to help patients.
We cannot guarantee that you will receive any personal advantages from participating in a LEO Pharma clinical trial. However, by participating in a clinical trial, you may gain access to new treatments that are not yet available to the public. Furthermore, you will receive expert medical care at a leading health care facility.
Potential risks of participating in a clinical trial may include unpleasant, serious or even life-threatening side effects from treatment. Moreover, the treatment may not be effective for some individuals. In fact, in trials that involve the use of placebos, some individuals will be assigned to a treatment, which contains no active ingredients. Also, the trial may require a lot of time for traveling to the trial site or clinic, receiving treatments, or hospital stays.