What is a clinical trial?

Before a drug can be sold to the public, pharmaceutical and biotechnology companies must put the drug through strenuous testing to ensure both its safety and efficacy.  Generally, drug candidates are studied in the laboratory pre-clinically and tested on animals prior to human testing.  If the drug appears to be safe and effective when tested in animal and laboratory models, then clinical testing in humans may begin. 

 

There are three phases in clinical trial development.  The first phase can be either a Phase I or Phase I/II study. The main objective in this type of study is to determine if the drug is safe and only a small number of patients are treated.  In the Phase I study healthy patients are treated, whereas in the Phase I/II study, patients who have the disease the drug is targeting are treated.  If results from the Phase I or I/II study are positive, then a Phase II study may begin.  A larger number of patients who have the targeted disease are included in a Phase II study, which measures efficacy in addition to safety.  Phase III studies often contain a larger number of ill patients and are used to further establish efficacy.  If positive results are achieved, the 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 (EMEA) in Europe.  If approved, the company can then produce and sell the product to the public.  
 

How can I find out about clinical trials Genmab is running?

Genmab posts details regarding its clinical trials in clinical trial databases in accordance with industry guidelines.  To learn about Genmab’s ongoing clinical trials visit ClinicalTrials.gov or Cancer.gov.

 

How can I enroll in one of Genmab's clinical trials?
It is best to contact your physician regarding participation in any clinical trial.  Your physician will be able to determine what clinical trials are running, where they are located, if you would be eligible to participate in the trial and whether participating in the trial would be right for you. 

 

Patient Resources

Patients may find useful information about their disease on the worldwide web.  Links to some patient resources for diseases Genmab is studying are below.

 

            Cancer 

            American Cancer Society

            Coalition of Cancer Cooperative Groups

            National Cancer Institute

            People Living with Cancer
            Cancer Care, Inc.
            Cancer Research and Prevention Foundation
            The Wellness Community                

            Head and Neck Cancer
            The Oral Cancer Foundation
             
            Leukemia and Lymphoma
            Leukaemia Research Fund  
            CLL Support Association
            CLL Global Research Foundation
            Lymphoma Research Foundation
            Lymphoma Foundation
            Cutaneous Lymphoma Foundation

            Lung Cancer
            Lung Cancer Alliance
            Lung Cancer Circle of Hope

            Multiple Myeloma
            Multiple Myeloma Research Foundation     
            

            Rheumatoid Arthritis 

            American College of Rheumatology

            Arthritis Foundation
            American Autoimmune Related Diseases Association