Online Class Notes (Ally)

Vocabulary

underlying: 根本的；潜在的；隐含的；表面下的

Good morning everyone. If everyone’s ready, let’s get started on today’s medical discussion. For our discussion today, we have invited colleagues from …, …, and … departments to join us to discuss about the inclusion criteria.

The first thing we want to discuss is the patient population of 311 study. Recently we had a SIV meeting in China, and the investigator raised some questions about the inclusion criteria. To begin, let’s turn to criteria 4. We feel there is a contradiction in this criteria. In this criteria, the underlying idea is that the patient must be in a very bad condition so he is not eligible for sc transplantation, but in our other criteria, such as number 9, we require the performance of patients to be fit. If a patient is very old, it’s easy for us to understand this criteria. I have checked, in the global study, there are some young patients aged around 35. We also have some potential young patients, who have relatively good conditions. But in a young patient, we are unclear about the specific requirements. What kind of condition indicators or features should our patient exhibit in order to meet both criteria?

Thank you for your answer to this question. Now let’s talk about the objective of study. We want to know the exact target population. This study is targeted for the population that is beyond the 2nd line treatment or those who are not candidates for transplantation. This population has three main groups; one is 2nd line, the other is past the 3rd line, and also the 1st line patients who are not qualified for transplantation. We want to know the priority of enrollment. Which is our top choice or our main target group? Because it is relevant to the indication.

Our third concern is about randomization. As stated in our protocol regarding randomization, randomization should be stratified based on prior treatment regimens. Our enrolled patients should consist of 50% 2nd line patients and 50% 3rd line patients. The objective of this stratification is that we have the same number of 2nd line and 3rd line patients. Our question is how can we ensure this? Globally, there is about an equal number of 2nd and 3rd line patients. But in China, the number may not be so balanced. We have a small 2nd line population, so it might be difficult for us to gather enough evidence to support the indication. So if the study is oriented towards 2nd line patients, we would try to enroll more of these patients.

Thank you so much for your clarifications. And also a thanks to all the participants from other functions for joining us today. That concludes our meeting for today. Thank you for all your time.