We are developing and delivering novel therapies that improve patients’ lives.
Curis is extremely thankful for the commitment that the patients, families, investigators and hospitals make when they participate in our clinical studies. Patient participation helps to provide data which can provide a better understanding of disease and potential therapies.
Participating in Curis Clinical Trials:
Patients may be provided Curis’ investigational drugs in the following ways (after meeting qualifying criteria): by participating in clinical studies, through expanded access programs (EAPs), and through investigator-sponsored or investigator-initiated studies.
At Curis, clinical studies are conducted to test the safety and effectiveness of investigational drugs according to the requirements of health authorities such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
Patients must meet the eligibility criteria of a study in order to participate. These criteria are defined in a study protocol and reviewed and approved by Institutional Review Boards (IRBs) prior to patient participation.
For studies now enrolling at Curis click here.
Expanded Access (EA):
Sometimes called “compassionate use”, expanded access is a potential way for a patient with an immediately life-threatening condition or serious disease or a condition to gain access to an investigational drug for treatment outside of clinical studies where no comparable or satisfactory alternative therapy options are available.
Even if a patient meets the criteria under the law and the FDA regulations, the licensed physician, the Institutional Review Board (IRB), and Curis all need to agree that expanded access is appropriate for the patient.
For Expanded Access requests by physicians click here.
Investigator-Sponsored Trial (IST) or Investigator-Initiated Trial (IIT):
Similar to clinical studies, IST or IIT studies provide qualifying patients with access to investigational drugs. Data is collected to better understand safety and efficacy where the sponsor-investigator assumes responsibility for all aspects of the research.
For IST or IIT requests by physicians click here