Oncologie is developing next-generation treatments (biologics and small molecule medicines) using cutting edge approaches to patient selection and clinical trial design. In order to develop these investigational medicines, we conduct clinical trials to determine the safe and effective use of these investigational medicines (or treatments). Regulatory approvals are required before drugs can be made available to patients outside of a clinical trial setting.
Clinical trials are controlled research studies designed to determine if an investigational medicine is safe and effective. Oncologie believes participating in clinical trials is the optimal way for patients to access investigational medicines prior to regulatory approval. Various efforts including, but not limited to, conduct of global clinical trials and posting on clinicaltrials.gov, ensures awareness of our clinical trials and the opportunity to participate to interested patients.
Providing access to investigational medicines via clinical trials is not always possible, so when it is not possible for a patient to participate in a clinical trial and all other available medical options have been exhausted, the patient’s physician may seek special access to investigational medicines outside of the clinical trial setting. These situations are often referred to as expanded access, early access, pre-approval access, compassionate use and emergency use.
Making decisions about requests for expanded access to an investigational medicine is always complex. Oncologie endeavors to make these decisions as ethically and fairly as possible, taking into consideration the patient’s case, the available medical and scientific information about the investigational medicine, and the probability and timing of a regulatory approval. The most important factor when evaluating requests for expanded access to investigational medicines is to ensure patients are not exposed to unnecessary harm or risk.
Oncologie will consider an expanded access program, or a single request for expanded access of an investigational medicine, only if all of the following criteria are met:
Onocologie encourages patients to speak first with their licensed physician about their eligibility to enroll in a clinical trial. If a treating physician believes expanded access may be the only option for a patient, the physician should contact Oncologie to make a formal request on behalf of the patient. The requesting physician must agree to obtain appropriate regulatory and ethics committee approvals, if applicable, and to comply with all other safety, monitoring, and patient consent requirements. Requests for expanded access may only be made by licensed physicians through the below email address and will be evaluated by Oncologie Clinical Leadership. Oncologie will acknowledge receipt of requests within five business days.
Oncologie is committed to evaluating all requests for expanded access in a fair and equal manner.
All requests will be evaluated by medical professionals and decisions will be made based on scientific evidence available to the company at the time of the request.
Please contact Oncologie if you have questions about or requests for expanded access to Oncologie investigational compounds. Please contact firstname.lastname@example.org.