Clinical studies you should know about
Clinical studies are an important part of the drug development process and a critical research tool for advancing patient care and bringing new medicines to individuals and families who need them. Enrollment in one of our clinical studies is the primary way in which we can provide individuals living with serious viral and liver diseases access to our investigational drugs prior to their potential approval by regulatory authorities, such as the United States Food and Drug Administration. Clinical studies are required to demonstrate that an investigational medicine meets necessary safety and effectiveness standards before it is approved and becomes commercially available to the public.
Individuals who participate in clinical studies help to advance new scientific discoveries and make better future treatments possible. If you or a loved one is interested in participating in a clinical study evaluating a novel investigational therapy, taking part may provide you with an option to help manage your condition. It is important to understand, however, that there are inherent risks and other obstacles to consider when thinking about participating in a clinical study. These considerations include, but are not limited to, meeting participant eligibility criteria, committing to a long-term process that can take months or even years to complete, and understanding the known and unknown risks associated with any investigational therapies. Since participating in a clinical study comes with certain risks, you will be asked to provide your “informed consent” prior to enrolling.
Expanded Access Policy
We are committed to developing innovative therapeutics targeting serious viral and liver diseases. Participation in one of our clinical trials is the primary means by which patients may access our investigational therapies prior to potential regulatory approval. Information about our clinical trials can be found on clinicaltrials.gov.
At this time, Assembly Bio does not offer an expanded access program, also known as compassionate use, for any of its investigational therapies and does not accept expanded access requests.
Assembly Bio will re-evaluate and may revise this policy from time to time.