About Clinical Trials
For more information about Alnylam’s ongoing clinical trials, click here.
For more information, and to speak to someone from our team, please contact us:
Alnylam Clinical Trial Information Line
866-330-0326 (Toll-free within the U.S.)
+1 617-575-7400 (International)
A clinical trial is a medical or health-related research study conducted in humans to answer specific questions about potential new treatments for diseases. In most cases, the drugs being investigated in clinical trials have not yet been approved for marketing and sale by regulatory agencies (such as the U.S. Food and Drug Administration, or FDA), and so the benefits and risks of taking the treatment may not be known. Clinical trials are carried out to determine whether new treatments are safe and effective for patients.
What Is A Clinical Trial?
A clinical trial involves research using human volunteers (trial participants), and is intended to add to medical knowledge. Results can make a difference in the treatment of current and future patients by providing information about the benefits and risks of a potential drug.
What Are the Phases of Clinical Trials?
Clinical trials of investigational treatments or drugs are generally conducted in phases. Each phase is designed to increase the understanding of the drug’s effect on the body in terms of safety, as well as its impact on disease.
- Phase 1 studies are usually conducted in healthy volunteers and focus on safety.
- Phase 2 studies focus on the drug’s effectiveness within the particular disease, while continuing to monitor the drug’s safety.
- Phase 3 studies continue to collect information about a drug’s safety and effectiveness.
Before a drug can be sold commercially, data gathered in Phase 1, 2 , and 3 studies must be submitted for review and approval by regulatory authorities like the US Food and Drug Administration (FDA). The goal of this process is to be able to demonstrate that a drug can be administered safely and that it will provideclinical benefit. Through this process, new and alternative treatment options are approved for commercial sale.
After a drug is approved, Phase 4 studies may also be conducted to provide additional information on the risks, benefits, and use of a drug in a broader patient population.
Who Can Participate in a Clinical Trial?
Clinical trials include standards that describe who can participate, called eligibility criteria. These are outlined in a research plan or protocol. Certain factors such as age, gender, or stage of the disease, could allow or disqualify participation in a clinical trial (referred to as inclusion and exclusion criteria).
What Are the Benefits and Risks of Participating in a Clinical Trial?
- Play an active role in your health
- Be considered for access to investigational therapies for your condition
- Help others by contributing to the investigation of new ways to diagnose, prevent, and treat diseases
- Possible unknown or serious treatment side effects
- Possibility of a lack of benefit or positive clinical outcome for participant
- Increased time commitments for study visits
Where Can I Learn More About Clinical Trials?
Visit www.clinicaltrials.gov for information on eligibility to participate in a study, risks and benefits of study participation, the informed consent process, questions to ask when considering whether to participate in a study, and much more information regarding clinical trials.
Visit www.ciscrp.org, the Center for Information and Study on Clinical Research Participation (CISCRP), an independent non-profit organization dedicated to educating and informing the public and patients about clinical research.