Online Class Notes (Ally)

Vocabulary

on your end: on your side

invincible: 无敌的

western european
west european countries
western europe

nothing will hurt them
they won’t be influenced
this has nothing on them
this means nothing to them
this is meaningless for them

I can’t think of anything.

Presentation:

Background info on China
– different clinical practices between China and Western countries

Current situation:
– Inclusion/Exclusion Criteria, CDE standard

Risk:
– mixed population
– confused result
– application for market in China

Suggestion/soluton:
-make a protocol amendment for China

First of all, let me provide some background information on the very different clinical practices regarding treatment of lymphoma in China and in the Western countries. In Western countries, chemotherapies containing R is always the first line of treatment. About 99% of lymphoma patients would receive R as part of their treatment. But in China, the treatment is very different. Because of the cost, not every patient receives regimens that contains R. Abt 30-40% of patients cannot receive R as the first line treatment, since R is not covered by the China health insurance.

As for our trial, the current situation is that the current I/E criteria is relapsed and refractory, … There is no clear criteria about the first-line treatment, none about the usage of R. However, in the requirement of the CDE, they gave us a clear definition of. … therapies. They specifically require that only patients who receive… regimens containing R can be enrolled. So right now, there are differences between the protocol and the regulatory requirements.

If we enroll the patients according to the current protocol, it will lead to a mixed population because unlike western countries, it is likely that the patients we enroll have not received the 4 cycles of R. Due to this problem of our trial, we would not be able to conclude if the good efficacy results from the drug itself or from the mixed population. Also, it would have a negative effect on the market application in China, because the patients enrolled may not be accepted by the CDE, especially if we disregard their specific instructions. So we want to make a protocol amendment to clarify the definition of the first line of treatment in our I/E criteria. 

Do not hesitate if you have any questions. I’m happy to answer any questions you may have. Since it’s a cross-functional matter, I will let my colleagues from other departments tell you more./take it from here.

according to the clinical practice in China, 4 cycles is the minimum treatment because if the patient is not refractory to R, usually they will receive 6-8 cycles, so 4 cycles makes sense.