Online Class Notes (Ally)

Vocabulary

subsequent: next

shortage: 缺乏
ie. shortage of food, supplies…

shortcoming/weakness

Hi everyone. In our last meeting, we were talking about… understanding the protocol req about the .. and looking into the system to find out more.

Hi everyone. In our last meeting, we were talking about two major topics. One is the definition of relapse and refractory disease and the other is patient worksheet review. First of all, I want to ask if there are any new findings regarding these topics?

I want to say thank you for the past 2 weeks, thanks to your professional and rapid response. In the past 2 weeks, we were able to screen 4 subjects and enroll 1 subject. I reviewed the 4 worksheets and found the common problems, such as the refractory and relapse disease in the worksheet. I found that the info regarding the refractory or relapse were wrongly entered from the site. So I wanted to ask your opinion about that. It seems that in the worksheet, our current definition of refractory and relapse disease is not very clear. I think Michael had a good suggestion in the email – I think we need to revise our worksheet to avoid future mistakes by the site. Maybe we can change the relapse or refractory disease to last prior line. This is option one. Option two is that we delete this item from our worksheet completely, because we can tell whether it is refractory or relapse from the subsequent section provided in the worksheet. So it’s actually not necessary to require the site to fill out this information. What’s your opinion about this?

Let’s move on to the second topic, which is about d usage. You were saying in the previous email that d is typically given to control symptoms rather than for its anti-cancer properties, which means we can use this drug to control cancer-related symptoms. But I want to ask when we use d, how can we differentiate the two purposes and make sure we are only treating the symptoms and not effecting the cancer cells. Can I get your suggestion about this?

The third topic is about adequate treatment for transformed cancer. In our protocol, we require 4 cycle of r and a for … but for the transformed cancer, is that also a requirement? Is it mandatory for all forms of transformed cancer? Is it the same requirement for other sites in other countries? When I checked the system today, I found that one case in the site 500 did not follow this requirement, so I was wondering the requirement is necessary for all cases.

If we insist on this requirement, this subject would be considered screen failure. We have to provide strong rationale and clear definition about this in order to persuade the PI, especially because that there are discrepancies between this specific requirement and the China situation.

Thank you all for taking the time to attend this meeting. See you next time. I will send you the meeting minutes after the meeting.