What is a clinical trial?
Pharmaceutical and biotechnology companies must conduct strenuous testing to ensure both the safety and efficacy of a drug before it can be approved by regulatory authorities and sold to the public. Generally, drug candidates are studied in the laboratory and tested on animals before being studied in people. If the drug appears to be safe and effective when tested in the laboratory and in animals then clinical testing in humans may begin. What are the phases of clinical trial development?
What clinical trials is Genmab running?
- Phase I – This type of study includes a small number of healthy volunteers and is used to determine if a drug is safe.
- Phase I/II – Like a Phase I study, a Phase I/II study also measures safety, however, patients who have the disease the drug is targeting are included.
- Phase II – A larger number of patients who have the targeted disease are included in a Phase II study, which measures how well the drug works (efficacy) in addition to safety.
- Phase III – A Phase III study is used to confirm efficacy seen in earlier stage trials. If positive results are achieved, a biotech or pharma company may apply for approval to market the drug with the appropriate drug regulation organization, such as the Food and Drug Administration (FDA) in the United States or the European Medicines Agency (EMA) in Europe.
A summary of our product information can be found on our Products in Development page on this website. Detailed information about Genmab's clinical trials is posted in clinical trial databases in accordance with industry guidelines. To learn about Genmab's ongoing clinical trials visitClinicalTrials.gov. More information about cancer can be found at the following websites:
How are patients enrolled in Genmab's clinical trials?
Physicians can help patients determine what clinical trials are running, where they are located and eligibility to enroll.