We understand that sometimes people may seek access to investigational medicines before they are reviewed and approved by a regulatory authority, such as the U.S. Food and Drug Administration (FDA). This can be done in two ways – through clinical trials and expanded access.
Our goal, whenever possible, is to encourage patients to participate in clinical trials. Clinical trials are research studies designed to determine if an investigational medicine is safe and effective for patients. Data generated by these studies provide regulatory authorities with essential information needed to evaluate a medicine. Only after reviewing this information will regulators approve a new medicine, allowing it to be widely available.
In rare cases, however, when people don’t qualify for clinical trials, have exhausted all available medical option and the investigational medicine has demonstrated some preliminary efficacy and safety; companies may consider providing an investigational medicine outside of a clinical trial. This is called expanded access.
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for more information.
Types of Access to Investigational Medicines
Because clinical trials are well-controlled and usually require a large number of patients, they offer the safest and best opportunity for people to access an investigational medicine before it is approved by a regulatory agency. Clinical trial participants receive quality care as the health care providers managing the clinical trial closely monitor participants and all aspects of their disease. In addition, clinical trial participants contribute to greater scientific understanding of their disease and the investigational medicine being studied. This important information may lead to a new approved medicine.
To learn more about available clinical trials visit clinicaltrials.gov and search by company, disease or medicine.
Expanded access, also known as compassionate use, may be an option for a limited number of individuals with serious or life-threatening conditions, who have exhausted all available medical options and do not qualify for clinical trials.
Given the stage of development for Seclidemestat, Salarius is not currently offering expanded use programs.
Please continue to monitor clinicaltrials.gov for additional options and continue to monitor our website for changes to our expanded use programs.
Clinical Trial Results Sharing
Salarius Pharmaceuticals recognizes the importance of informing the public about the results of its interventional clinical trials for innovative compounds, regardless of the outcome. Knowing the results of these trials enables both patients and their healthcare providers to make well-informed decisions regarding treatment risks and benefits.
For more information on current clinical trials please use the following website.
In addition, the search engine offered by the World Health Organization (WHO) collects registry information from multiple databases and thus provides an overview on information about worldwide pharmaceutical research published in leading Clinical Trial Registries.