Roll-In Subjects:
Definition: Roll-in subjects are participants who are already enrolled in a related study or trial and are subsequently included in a new study without going through the initial screening or recruitment process.
Explanation: When designing a clinical trial or research study, researchers sometimes include participants who were part of a previous study (often a related or precursor study) to expedite recruitment and ensure a sufficient sample size. These participants are considered “roll-in” subjects because they “roll over” from one study to another.
Purpose: Including roll-in subjects can be beneficial for efficiency, especially when the new study has similar eligibility criteria or endpoints as the previous one. It allows researchers to leverage existing data and potentially accelerate the overall research process.
Considerations: Researchers carefully evaluate whether roll-in subjects meet the inclusion criteria for the new study and ensure that their data is appropriately integrated into the analysis.
Example: If a participant was part of a safety study for a drug candidate and a subsequent efficacy study is planned, they may be considered a roll-in subject for the efficacy study.
Roll-In Devices or Treatments:
Definition: Roll-in devices or treatments refer to previously approved or tested interventions that are incorporated into a new study.
Explanation: In medical device trials or clinical studies, roll-in devices are those that have already undergone safety testing or received regulatory approval. Researchers may use these devices as a reference or control group in a new study.
Purpose: Including roll-in devices allows researchers to compare the new intervention (e.g., a novel medical device) with an established standard or previously tested treatment.
Considerations: Researchers ensure that roll-in devices are well-characterized and that any differences between them and the new intervention are appropriately accounted for.
Example: If a new cardiac stent is being tested, the study might include patients who previously received an approved stent as roll-in subjects.
Roll-In Criteria:
Definition: Roll-in criteria are the specific conditions or eligibility requirements that determine whether a participant or device qualifies as a roll-in subject.
Explanation: Researchers define roll-in criteria based on the study’s objectives and the characteristics of the previous study or device. These criteria guide the selection of roll-in subjects or devices.
Purpose: Clearly defined roll-in criteria ensure consistency and transparency in participant selection.
Example: Roll-in criteria might specify that a participant must have completed a specific phase of a previous trial or received a particular treatment to be eligible as a roll-in subject.