How to Abstract Interventional Trial Design Details
Search for the trial of interest. For instructions, refer to Searching for Trials in PA.
In the search results, click the NCI Trial Identifier link for that trial. The Trial Identification page appears.
On the Trial Identification page, check out the trial. For instructions, refer to Checking In and Checking Out Trials. (This checkout step is optional for Super Abstractors.)
On the Scientific Data menu, under Interventional Trial Design, click Design Details. The Interventional Trial Design Details page appears.
On Interventional Trial Design Details page, in the various fields, specify the appropriate information. The following table describes the fields. An asterisk (*) indicates a required field.
Trial Details
Instruction
Study Type* Select Interventional. (Selected by default)
If you select Non-Interventional, the page will display the fields associated with non-interventional trials and you may lose any data you may have entered already.
Expanded Access? 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.
Primary Purpose*
1. Select the primary reason for conducting the trial. For valid values, refer to Primary Purpose Value Definitions.
2. Optionally, if the primary purpose is Other, type a detailed description of the trial’s purpose in the text field provided.
The text field is displayed only after you have selected Other.
Secondary Purpose 1. Select one of the following reasons for conducting the trial.
- Ancillary-Correlative. A trial that is secondary to another trial, or a type of trial that tests for a relationship between a condition and a potential causal factor of the condition.
- Ancillary. Studies that are stimulated by, but are not a required part of, a main clinical trial/study, and that utilize patient or other resources of the main trial/study to generate information relevant to it. Ancillary studies must be linked to an active clinical research study and should include only patients accrued to that clinical research study. Report only those studies that can be linked to individual patient or participant data.
- Correlative. Laboratory-based studies using specimens to assess cancer risk, clinical outcomes, response to therapies, etc. Report only those studies that can be linked to individual patient or participant data.
- Other. Any purpose other than Ancillary-Correlative.
2. If the secondary purpose is Other, enter a detailed description of the trial’s purpose in the text field provided.
Pragmatic Trial
1. Trial Details - Pragmatic Trial
2. Instruction - Select Yes or No from the drop-down list to indicate whether the trial you are registering is a pragmatic trial.
Trial Phase*
Select the current phase of the trial. For valid values, refer to Trial Phase Value Definitions.
Is this a Pilot? Select Yes or No from the drop-down list to indicate whether the trial you are registering is a pilot trial. Interventional Study Model*
Select one of the following main study designs.
- Single Group. Single-arm study (i.e., all patients receive the same intervention).
- Parallel. Patients are assigned to one of two or more intervention arms for the duration of the study.
- Cross-over. Participants receive one of two alternative interventions during the initial phase of the study and receive the other intervention during the second phase of the study (only assigned when the protocol specifically says this is the intervention model; otherwise, default to parallel).
- Factorial. Two or more interventions, each alone and in combination, are evaluated in parallel against a control group (only assigned when the protocol specifically says this is the intervention model; otherwise, default to parallel).
- Sequential Assignment. Groups of participants are assigned to receive interventions based on prior milestones being reached in the study, such as in some dose escalation and adaptive design studies.
Model Description Provide any available details about the Interventional Study Model. Number of Arms*
Type the number of treatment groups in the trial.
Important
The number of arms you enter in this field must coincide with the number of trial arms you recorded or will record on the Arms page (see Abstracting Arms). Do not leave this field blank or enter "0" (zero).
Masking*
Select all of the roles that are masked, or select No Masking: - Participant: The participant (or subject) is unaware of the intervention assignment.
- Investigator: The investigator is unaware of the intervention assignment.
- Care Provider: The care provider (or caregiver) is unaware of the intervention assignment.
- Outcomes Assessor: The outcomes assessor is unaware of the intervention assignment.
- No Masking: All people involved in the study know the identity of the intervention assignment.
Masking Description Provide any available details about the masked parties. Allocation*
Select the means by which participants are assigned to an intervention group.
- N/A. For single-arm studies.
- Randomized Controlled Trial. Participants are assigned to intervention arms by chance.
- Non-Randomized Trial. Participants are expressly assigned to interventions groups through a non-random method, such as physician choice. Applicable for multi-arm studies that do not specify randomization.
Target Enrollment*
If the Enrollment Type is Anticipated, enter the target number of subjects in the study.
- Do not give a range.
- Add the number of subjects in each arm or phase together to get the total enrollment if needed.
- Use the informed consent document to help you to identify the target enrollment if the protocol is unclear.
Final Enrollment for ClinicalTrials.gov
If the Enrollment Type is Actual, but the final enrollment has not been recorded or the value was corrected for the Results Reporting, you can enter the final number of subjects accrued.
The system records a count of 0 if you do not enter a Final Enrollment accrual count, and the number of subjects accrued to date is 0.
Accruals The system enters the number of accruals recorded to date in the CTRP automatically. You can not change this number. - Click Save.
