My team conducted a prospective objective clinical study where we followed-up cancer patients who took a certain medication while undergoing conventional chemotherapy.
We used objective reponse rate, which was evaluated using RECIST v1.1
During a period of one year, most patients underwent three times of tumor response evaluation (about every 3-4 months)
Say that we have three patients who had
Patient 1: SD > SD > SD
Patient 2: SD > SD > PD
Patient 3: SD > PR > SD
In this case, can we say that the objective response rate was 33%?
Thank you in advance
When reporting the Objective Response Rate (ORR) in a clinical study, consider the following key elements: 1. **Definition of ORR:** Clearly define how you calculated the ORR. Typically, it's the proportion of patients with a predefined level of tumor shrinkage (partial or complete response) based on imaging assessments. 2. **Study Population:** Specify the population included in the analysis, such as the intention-to-treat (ITT) population or a specific subgroup. 3. **Time Frame:** Report the time frame for assessing ORR, whether it's at a specific point during treatment or a cumulative response over a set duration. 4. **Percentage and Confidence Intervals:** Provide the percentage of patients with objective responses and include confidence intervals, which convey the precision of your estimate. 5. **Response Criteria:** Clearly state the criteria used for assessing response (e.g., RECIST criteria for tumor measurement) and any modifications or additional assessments made. 6. **Data Source:** Indicate the source of data, specifying if the information comes from centralized review, investigator assessment, or a combination. 7. **Subgroup Analysis:** If applicable, report ORR for relevant subgroups (e.g., different tumor types, genetic mutations) to explore variations in treatment response. 8. **Duration of Response:** Include information on the duration of response for responders, providing insights into the sustainability of treatment effects. 9. **Comparisons:** If relevant, compare the ORR between treatment arms or with historical controls, emphasizing any statistically significant differences. 10. **Limitations:** Acknowledge any limitations or potential biases in the ORR assessment, such as challenges in imaging interpretation or patient selection. 11. **Consistency with Previous Studies:** Discuss how your reported ORR aligns with or differs from ORR reported in similar studies, providing context for interpretation. By addressing these aspects, you ensure a comprehensive and transparent presentation of the ORR, facilitating a clear understanding of the treatment's efficacy in the studied population.
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