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ClinicalTrials.gov User Guide

For Patients/Caregivers
For Physicians

Expanded access can be an option for patients with serious or life-threatening diseases, who have exhausted all FDA-approved treatments, to access investigational products. If you are a patient, caregiver, or physician looking for investigational therapy options, you can begin to research and identify them on ClinicalTrials.gov

Clinical trials give patients an opportunity to receive an investigational therapy for the purpose of research to determine if the therapy is safe and effective. Whether you know just the condition that requires treatment or you know both the condition and the investigational therapy you would like to access, you can use ClinicalTrials.gov to learn more about what products are in development, whether clinical trials are open and available for enrollment, and the eligibility criteria. You may also find whether expanded access is available for the therapy and contact information where you can obtain additional information. 

This user guide will take you through the process of using ClinicalTrials.gov website for the following:

  • Researching products in development based on a patient’s condition
  • Finding open clinical trials 
  • Finding expanded access programs (EAPs) 
  • Finding single-patient expanded access

How to Use ClinicalTrials.gov to Research Products in Development

Conducting a Search

Use the ClinicalTrials.gov search function to start researching new investigational therapies. For example, if the patient has lung cancer, you can use a ClinicalTrials.gov search to find investigational therapies intended to treat specific types of lung cancer.

New Search

If you are conducting initial research of investigational therapies or know only the patient’s condition, you may want to consider using the basic search feature on the home page of ClinicalTrials.gov to receive a range of information on possible treatments.

Populate the fields that apply to your search, like the name of the condition or disease, or the title of a specific treatment. Filling more fields will narrow your search results. For example, if the patient has breast cancer and is looking for radiation treatments, completing these fields in the basic search will only populate results that meet both criteria. You can also expand or narrow search results by using capitalized operators such as AND, OR, and NOT to relate terms. 

Advanced Search

The advanced search feature allows patients, caregivers, and physicians to focus their results even further with additional criteria like location, eligibility information, and study type. For example, if you would only like to receive results for therapies for breast cancer in women age 60 and older, then use the advanced search to fill these fields and find results specific to these criteria.

To access this search, select “Advanced Search” on the homepage. You do not need to fill every field on the advanced search feature, but the more fields entered, the narrower your search results become. If a limited number of studies appear, consider removing one or more of the search fields to broaden results.  

Browse Studies by Topic or Location

ClinicalTrials.gov also allows users to browse information on studies organized by topics such as condition, treatment intervention, sponsor/collaborator, location, and more. For example, to find all the studies available for esophageal cancer, select the “Rare Diseases” topic. Scroll through the list to find the disease and click the esophageal cancer link. This will populate all the studies specific only to esophageal cancer. Continue reading to learn more on how to filter search results to find the studies that are most appropriate for the patient’s condition. 

Filtering Search Results

Once you have completed a basic or advanced search, you will be presented with a list of studies. Studies that are most relevant to the search terms will appear at the top of the results page. The results page will show the name of the study and its status (e.g. active, completed, recruiting, etc.), conditions or diseases it addresses, and interventions. 

Depending on how narrow your search terms are, your list may provide many results. To find the studies best suited for the patient, use the ClinicalTrials.gov filter feature in the panel on the left side. You can filter studies by status, expanded access availability, eligibility criteria, and more. Select any additional categories to narrow your search, then select “Apply” to update results. Along the top of the results page, you can also use the tabs to view the search results by topic, location, and related search details.

Selecting a Study

Once you have applied filters, the list of studies will decrease. Click on the “Study Title” for more information regarding the therapy.

A page of information pertaining to the intervention, purpose of the investigational product, eligibility, and contact information for the trial organizers will be provided.

Saving Studies

If you have found studies you wish to save under your search results, click the “Saved” box beside the study on the “search results” page. This will allow you to later revisit the information you found. To access saved studies, click of “Saved Studies” located in the upper right corner of any page.

How to Use ClinicalTrials.gov to Find Active Clinical Trials Recruiting Patients

Once you have identified an appropriate investigational therapy by using the “Intervention/Treatment” search field (or by returning to your saved searches), you can use ClinicalTrials.gov to determine whether there are any ongoing clinical trials enrolling patients, for which you or your patient may be eligible. To find open clinical trials, select “Recruiting” under “Status” (in the left panel on your search results page). Your results will then narrow to those studies that are currently recruiting participants. Select “Apply” at the top or bottom of the menu to update your search results.

You may also want to use the other filters available in this menu to learn more about the status of the therapy. The organizers of the trial will provide a point of contact for additional information about the trial(s). You will also be able to see where the trial is being conducted, to determine if traveling is feasible for you.

How to Use ClinicalTrials.gov to Find an Expanded Access Program (EAP)

You, or your patient, may be ineligible for, or unable to participate in a clinical trial. Or, all the relevant clinical trials may have completed enrollment or be finished. It is still possible that an investigational treatment is available through established expanded access from single-patient to intermediate size or large programs.

In the same left panel on your search results page where you found “Status” (which you use to determine if a clinical trial is active and recruiting patients), you will see an option for “Expanded Access.” To find out if the pharmaceutical company is making the investigational product available through expanded access, select “Available” under “Expanded Access.” Select “Apply” at the top of the menu to update your search results.

How to Use ClinicalTrials.gov to Find Single-Patient Expanded Access

Because of a new requirement for listing expanded access information on ClinicalTrials.gov, some listings will include information on whether the investigational drug product may be available through single-patient expanded access. For more details about such access, you can use the point of contact located within the entry.

If no expanded access is listed, it does not necessarily mean the drug sponsor is unwilling to entertain a request for access. You or your doctor may contact the sponsor to discuss the possibility of individual access.

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