Participating in a clinical trial
What is a Clinical Trial?
Pharmaceutical companies often sponsor clinical trials for an investigational drug or product in order to test a new medication they have developed. Before initiating a trial in humans, the pharmaceutical company must rigorously test the medication both in the lab and in animal studies. From there, the trial details are planned out and allowed by regulatory agencies and ethics committees. Only after approval can the company move ahead with the clinical trial by recruiting candidates to begin human testing.
Who can participate in a clinical trial?
People who volunteer for participation in the study are selected for participation based on a set of pre-defined and approved criteria. Typically, it is not enough to have the specific condition for which the new medicine is being tested; individuals may also need to be of a certain age or have a specific type of the condition in order to qualify. Often, patients are not allowed to have other conditions than the one being tested.
Why should I participate in a clinical trial?
During the clinical trial patients receive a great deal of focus and attention from highly-qualified investigating doctors and their staff. Clinical trials contribute to the medical knowledge around a particular disease area. These trials help companies develop new medication that, once tested and approved, may be used to help patients worldwide.
What happens if I sign up for a trial?
Before deciding whether to participate in a clinical trial, you will be fully informed about the relevant details. You will be told about your rights, responsibilities and about risks involved. You can always choose to withdraw from a trial without penalty or loss of benefits to which you are otherwise entitled. Participating in clinical trials is voluntary and entirely your own decision.
Are there any risks?
Medications are usually tested in a lab and on healthy volunteers before being tested on patients in a clinical trial. Although this minimizes certain risks, the medication is still new and experimental. As such, you may experience side effects that the pharmaceutical company is not yet aware of. There is also no guarantee that the medication will improve your condition. It is possible that the medicine does not work for you, or that you received a placebo medication with no active ingredient– see below.
What happens during a clinical trial?
All volunteers will be evaluated to identify whether their circumstances fit the trial criteria. This often includes taking blood samples, measuring blood pressure and evaluating other specific health parameters. If you are eligible to participate, you will be given a test treatment. This test treatment may be the new medicine being investigated or a comparator (placebo or other drug already on the market to treat psoriasis). The reason comparators are used is to validate the results from the trial. The test treatment and comparator are randomly assigned to trial participants. In most trials, neither you nor your doctor will know which treatment you receive. During the trial you will be monitored and you may have to visit the doctor several times. The visits to the doctor may include more samples and tests to evaluate the treatment. After the trial is completed you will find out which treatment you received.
How do I sign up?
LEO Pharma is a leading pharmaceutical company focusing on alleviating the effects of various skin conditions. In particular, the organization focuses on psoriasis and thus often conducts trials for investigational psoriasis medications that may, if proven to be safe and effective, improve the quality of life for these patients. A list of LEO Pharma’s current psoriasis clinical trials can be found at leopharmatrials.com.
Here you can get information about the trials and sign up.
You can also register your interest in any future trials by submitting the web form.
You can find a thorough list of global clinical trials at clinicaltrials.gov. This site provides details on current trials around the world, as well as information about how you can sign up.
After the trial, patients are not allowed to continue the study medication.