Once you click on the title of a study from the Search Results page, it will open a Details page with up to 18 different fields of information about the program. All information on this page is taken from ClinicalTrials.gov which in turns relies on individual companies or other organizations to provide details. The Foundation is not responsible for the accuracy or completeness of these study records.
As your cursor hovers on the left column over key field names, such as EA Type, a window will pop open with a brief description. Here’s a quick reference to all of the terms.
The name of the drug manufacturer or distributor
Often a longer title of the program, which may provide you with additional details
A short description from the company about this particular expanded access offering
A more complete explanation of the expanded access program
Either "Available", meaning that expanded access is available for this drug/intervention at this time, "Temporarily Not Available", meaning expanded access is not currently available from this drug/intervention, but could be available in the future, or "Approved for Marketing", meaning the investigational drug has been fully reviewed by the U.S. Food and Drug Administration (FDA) and is either on the market or will soon be. Please contact the company in question for additional information. Contact information can be found in the Company Directory.
There are three types of expanded access categorized by FDA regulations:
- Individual Patients: Allows a single patient access to a drug or biological product that has not been approved by the FDA. This category also includes access in an emergency situation. To understand more about the single-patient expanded access process, please see the patient and physician guides on this website
- Intermediate-size Population: Allows more than one patient (but generally fewer patients than through a Treatment IND/Protocol) access to a drug or biological product that has not been approved by the FDA. This type of expanded access is used when multiple patients with the same disease or condition seek access to a specific drug or biological product that has not been approved by the FDA.
- Treatment IND/Protocol: Allows a large, widespread population access to a drug or biological product that has not been approved by the FDA. In some cases, this population may consist of patients who were previously enrolled in a clinical trial for the same investigational product and are allowed to continuing taking the product after the formal end of the trial. This type of expanded access can only be provided if the product is already being developed for marketing for the same use as the expanded access use.
A disease, disorder, syndrome, illness, or injury. Condition may also include health risks.
The specific type of treatment, such as drug, biological, medical device, procedure, and the name of the treatment, such as the drug name.
Information a company needs to know to determine if a patient qualifies for an expanded access offering. Criteria may include diagnosis, additional health problems, age, gender, or other factors.
Countries where the expanded access program is in operation. Please note that companies may support EA programs in multiple countries at one time, depending on local regulations and the stage of marketing approval.
For single patient access to a treatment, contact the company directly no matter the locations listed. The locations in this field may refer to intermediate-size treatment protocols already in place for single patients or groups of patients, but you should always contact the company first to confirm availability.
The name and contact information for the person at the company who can answer questions about expanded access. If multiple contacts are listed, reach out to the one directly at the company -- rather than a research institute -- first.
Sponsors are most often the company or companies that manufacture or distribute the drug. In some cases, the manufacturer is listed as a collaborator.
A researcher who is connected to the expanded access program, either associated with the manufacturer or the treatment site.
A unique identification code given to each clinical study record registered on ClinicalTrials.gov
Keywords and MeSH Terms
Words that are “key” for searching content of a listing – and may help refine your search