在做一个新药临床试验的翻译，平时做的研究涉及这方面的较少，请教大家一下，什么是2-arm study 呢，还有1-arm study,多谢~~~~
2-arm，就是两个治疗组群，一组研究药物，另一组为阳性药物起着对照作用，或者是安慰剂对照组。
1-arm，就是只有一组治疗群，一般采用观察性结果分析，或者那些非干预性研究的试验。
Arms/Groups (FDAAA) - if arms or groups have been specified for the protocol, select the ones for which the intervention is to be administered. For interventional studies with arms specified, all arms must have at least one intervention (unless arm type is "No Intervention") and each intervention must be assigned to at least one arm.
A common two-arm study is a comparison of drug versus a placebo or drug A versus drug B.In other words, it can be even three, four, and so on, arm studies, depending on the type of parallel group.
Below is the link to a sample of one-arm study.
http://clinicaltrials.gov/ct2/show/NCT00813202?term=one-arm&rank=5
pooq: Can you provide some non-interventional study as you have described?
We have 4 Intervention Models:
1 - Single Group
2 - Parallel Group
3 - Cross-over
4 - Factorial
a Single Group is a Single Arm study and a Parallel Group is a Two Arm study.
Parallel: participants are assigned to one of two or more groups in parallel for the duration of the study.
I think Mr pooq said non-interventional study may mean some prospective or conhort design, is it?
不好意思过了这么久才表示感谢哈，懂了嗯，看来以后得勤快点了
哦~~多谢帮助
，虽然我理解了半天，嘿嘿
2-arm，就是两个治疗组群，一组研究药物，另一组为阳性药物起着对照作用，或者是安慰剂对照组。
1-arm，就是只有一组治疗群，一般采用观察性结果分析，或者那些非干预性研究的试验。
Arms/Groups (FDAAA) - if arms or groups have been specified for the protocol, select the ones for which the intervention is to be administered. For interventional studies with arms specified, all arms must have at least one intervention (unless arm type is "No Intervention") and each intervention must be assigned to at least one arm.
A common two-arm study is a comparison of drug versus a placebo or drug A versus drug B.In other words, it can be even three, four, and so on, arm studies, depending on the type of parallel group.
Below is the link to a sample of one-arm study.
http://clinicaltrials.gov/ct2/show/NCT00813202?term=one-arm&rank=5
pooq: Can you provide some non-interventional study as you have described?
We have 4 Intervention Models:
1 - Single Group
2 - Parallel Group
3 - Cross-over
4 - Factorial
a Single Group is a Single Arm study and a Parallel Group is a Two Arm study.
Parallel: participants are assigned to one of two or more groups in parallel for the duration of the study.
I think Mr pooq said non-interventional study may mean some prospective or conhort design, is it?
不好意思过了这么久才表示感谢哈，懂了嗯，看来以后得勤快点了
哦~~多谢帮助
，虽然我理解了半天，嘿嘿