Clinical Trials
We’re passionate about improving the lives of patients by developing and commercializing innovative medicines. That means conducting rigorous clinical trials to get the best possible treatments to those who need them.
Clinical Trials
To provide safe and effective treatments
Our medicines undergo complex and rigorous testing in clinical trials, which helps researchers to determine if the treatments are safe and effective. To ensure this is the case, all medicines developed by Acadia must meet standards set by the U.S. Food and Drug Administration (FDA) and similar regulatory authorities worldwide before becoming widely available.
Clinical Trial Diversity
To achieve healthcare equity
We believe that achieving diverse representation in our clinical trials is essential to developing and commercializing therapies to ensure that study outcomes can be more broadly applied to achieve healthcare equity in the general population. We believe that clinical trial design and the diversity of its participants should more closely reflect the incidence and prevalence of the communities impacted by the disease states and therapies under evaluation.
To increase representation among diverse and underrepresented communities and to effectively address unmet needs in CNS and rare diseases, where appropriate, we aim to:
- Increase the diversity of clinical trial investigators
- Provide support to clinical trial sites and site staff
- Build partnerships with advocacy and professional organizations
- Elevate awareness through education and engagement with our employees, clinical trial sites, advocacy groups, and other study partners
Expanded Access
To improve healthcare in our community
We believe completing clinical research and partnering with regulatory authorities is the best approach to improve health outcomes for people with an illness or disease. For this reason, Acadia does not have an expanded access program that offers patients access to our investigational therapies outside of clinical trials or prior to FDA approval.
We believe clinical trials are the most appropriate way for patients to access investigational medicines developed by Acadia. In these trials, the safety and efficacy of investigational medicines is rigorously assessed by Acadia and the relevant regulatory agencies in order to understand the medicine’s benefits, risks, and appropriate use, including whether or not it should be approved as a therapy for its intended use. Obtaining regulatory approval is the best way to bring safe and effective medicines to the greatest number of patients who may benefit from treatment.
