Suppose that you are a member of a protocol review committee for the Eastern Cooperative Oncology Group. The attached protocol document has been submitted for committee review.
Please critique (attention: find the problem of each segment not only review) the protocol by listing any problems or issues (e.g., poor fundamental design issues, lack of sufficient detail or clarity, or inconsistencies) that you find. Please focus on design issues rather than the medical issues.
In addition, please focus on the following aspect of the protocol. (Please note that these are the items required for your Concept Capsule. A review of the Concept Capsule instruction is recommended before addressing these questions for this protocol.)
- Title: Is the study title appropriate?
- Primary Objective: Is the study objective stated clearly? Can you distinguish between primary vs. secondary objectives? Based on section 9, can you propose primary vs. secondary objectives?
- Population: What is the targeted study population and where was it defined?
- Standard of Care (SOC): Is it clear what the SOC is for this study population?
- Rationale: Is it clearly stated?
- Design:
a. Comments on the type/phase of the study.
b. Is this a superiority or non-inferiority design?
c. Is there a planned interim analysis? - Schema: Is it consistent with the protocol?
- Primary Endpoint:
a. Which outcome measure was used to derive the sample size?
b. How was this outcome measured in at the participant level? Where is it stated in the protocol? And at the group level? Contrast-level: N/A for this study.
Sample Solution