Expanded Patient Access to our InvestigationalMedicines
We are bringing innovative investigational medicines to patients as quickly as possible in a fair and ethical manner, and we believe in collaborating with patients, families, patient advocacy organizations, physicians, researchers, and regulatory authorities to accomplish this goal.
Expanded Patient Access to BioXcel Therapeutics’ Investigational Medicines
Evaluation of an investigational drug in clinical trials, which are designed to gain an understanding of the safety and efficacy of the drug in a specific population, is the optimal way to collect the information necessary to enable regulatory authority review and, ultimately, to bring the drug to the entire patient community. Participation in a clinical trial is also the best way for an individual patient to access an investigational drug for his/her disease. Our goal is to enroll and carry out robust, thoughtfully designed clinical trials as expeditiously as possible in order to support regulatory approvals and provide the broadest possible access to patients who might benefit from our investigational medicines.
We understand that in some cases there will be patients with a serious and immediately life-threatening disease for which no satisfactory treatment alternative exists, and for whom it is not possible to participate in a clinical trial. In these very specific circumstances, use of an expanded access program (sometimes called “compassionate use”) may be an option. Decisions about expanded patient access to our investigational medicines are made after thorough evaluation with the safety and well-being of the patient our foremost priority.
Decision Criteria for Considering an Expanded Access Program
An expanded access program for a specific investigational drug will be considered if the company determines that all the following criteria are met:
An adequate supply of the investigational drug exists to perform necessary clinical studies as well as to provide access to patients who do not have alternative treatment options
How To Request Early Access
A request for early access to our investigational medicine must originate directly from a licensed physician on behalf of his or her patient and should be forwarded to firstname.lastname@example.org (immuno-oncology). The requesting physician must agree to obtain appropriate regulatory and ethics committee approvals, as applicable, and to comply with all other safety, monitoring, reporting, and patient consent requirements defined by BioXcel Therapeutics. The company anticipates acknowledging receipt of requests for early access orally or in writing within five (5) business days. BioXcel Therapeutics is committed to evaluating all requests for expanded access in a fair and equitable manner.