What is a Clinical Trial?
One method for gaining access to investigational medicines is to enroll in a clinical trial. Clinical trials are scientific studies in which investigational medicines are tested to make sure they are safe and effective for people to take. They are one of the most important steps in bringing new medicines to patients.
Clinical trials allow pharmaceutical companies to get the scientific proof we need to ask a government health authority to approve our medicines. Getting that approval is important because it means that doctors can then prescribe the medicine to patients who may need it.
Researchers design clinical trials to answer specific scientific questions. Trials must be conducted as fairly and ethically as possible. Clinical trials are designed:
- based on accepted principles of medical research
- to meet the laws and regulations of government health authorities
- to make sure investigational medicines are safe and effective for people to take
- to obtain the government health authority approvals needed to bring new medicines to the largest number of patients in need
Clinical trials must be approved by government health authorities before patients can enter the trial and receive the investigational medicine. There are strict rules around how clinical trials must be run, and each trial is different. Patients must meet specific criteria to be included in a clinical trial. For example, to enter a clinical trial, the patient must have the type of disease that is being studied or patients may need the type of disease that is being studied AND have already tried other medicines that did not work as well as expected.
Sometimes patients cannot enter a clinical trial if they have other health conditions or problems in addition to the type of disease being studied or are taking certain other medicines that might interfere with the trial results or put patients at unreasonable risk.
Ask your doctor if participating in a clinical trial could be right for you. All of Janssen’s interventional trials in patients are listed publicly at www.clinicaltrials.gov. Search for a specific Janssen clinical trial at our Global Trial Finder website.
In addition to speaking with your doctor, additional information about clinical trials is available on the following sites:
Compassionate Use & Pre-Approval Access
Compassionate Use & Pre-Approval Access
