The criteria also help researchers identify a group of people with similar characteristics of a disease, making it easier and quicker for the researchers to evaluate the investigational therapy – potentially leading to faster review and approval. These criteria are important because they help researchers identify people who can participate. To participate in a clinical trial, a patient must meet the inclusion/exclusion (eligibility) criteria. Biogen strives to design and run clinical trials that will provide these regulatory agencies with the data they need to determine if an investigational therapy is beneficial to people.

Clinical TrialsĬlinical trials are the main way for patients to access investigational therapies.īiogen’s clinical trials are conducted to test the safety and effectiveness of investigational therapies so that regulatory authorities – such as the FDA in the United States and the EMA in Europe – can decide whether or not these therapies can be approved as a treatment for a disease.

Our ability to successfully complete the regulatory pathway and achieve the goal of broad therapeutic access for patients is essential to this mission. Our mission is to advance science in the development and approval of medications to benefit the greatest number of patients in a timely manner.

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