If the trial is an Expanded Access trial, select Yes. Otherwise, select No.
An Expanded Access trial describes the procedure for obtaining an experimental drug or device for patients who are not adequately treated by existing therapy, who do not meet the eligibility criteria for enrollment, or who are otherwise unable to participate in a controlled clinical study. Expanded Access records are used to register all types of non-protocol access to experimental treatments, including protocol exception, single-patient IND, treatment IND, compassionate use, emergency use, continued access and parallel track.
If you import an Expanded Access trial from ClinicalTrials.gov (whether via the Registration or PA web application), the system automatically sets this value to Yes. Otherwise, the default is No. The system does not include this attribute in the TSR, in the XML output to ClinicalTrials.gov, in the trial data sent to Cancer.gov, or in the set of trials provided to the NCI Clinical Trials API.
When a trial is listed as Expanded Access at the trial level in CTRP, the Expanded Access use of the drug/device will most likely be required by another interventional trial with an IND/IDE that is Available for Expanded Access. For instructions on configuring the separate Expanded Access fields as part of the IND/IDE for a trial, refer to Abstracting INDs and IDEs. Also, consider specifying each of these trials as an Associated Trial for the other. For instructions, refer to Associating Trials.
