写给webslave，NCI有关临床试药的科普指南，方便后来人

bjjww

webslave 发表于 2011-5-4 17:42
疗效还在打听中，国外有些人表示怀疑，6月份他们会出I 期实验报告。慈善总会没有消息。我们第一次介入后， ...

没错，只要你能通过入一旦入组，不需要个人掏医疗费用。这些数据报告只对FDA/NIH负责，和中国慈善总会没有任何关系。

请阅读 NCI -----临床试验科普指南，可以帮助你判断利弊是否要加入一个CA的临床试验。

How to Find a Cancer Treatment Trial: A 10-Step Guide
10步指南

http://www.cancer.gov/clinicaltrials/education/treatment-trial-guide

个人建议：1期是测试安全性---safety 和剂量确认---dose finding. 要权衡利弊。这一期，风险最大。

bjjww

NCI--美国国家癌症中心建议你和和试验小组直接联系。

Step 7: Contact the Clinical Trial Team-----和试验小组直接联系，中文翻译看楼下

There are many ways to contact the clinical trial team. 很多办法，

NCI -----临床试验科普指南
http://www.cancer.gov/clinicaltrials/education/treatment-trial-guide

10步，这是第7步。中文翻译在楼下。

Step 7: Contact the Clinical Trial Team和试验小组直接联系

There are many ways to contact the clinical trial team. 很多办法，

• Contact the trial team directly. The clinical trial summary should include the phone number of a person or an office that you can contact for more information. You do not need to talk to the lead researcher (called the “protocol chair” or “principal investigator”) at this time, even if his or her name is given along with the telephone number. Instead, call the number and ask to speak with the “trial coordinator,” the “referral coordinator,” or the “protocol assistant.” This person can answer questions from patients and their doctors. It is also this person’s job to decide whether you are likely to be eligible to join the trial. (A final decision will probably not be made until you have had a visit with a doctor who is taking part in the trial.)
• Ask your doctor or another health care team member to contact the trial team for you. Because the clinical trial coordinator will ask questions about your cancer diagnosis and your current general health, you may want to ask your doctor or someone else on your health care team to contact the clinical trial team for you.
• The trial team may contact you. If you have used the Web site of a clinical trial listing service and found a trial that interests you, you may have provided your name, phone number, and e-mail address so the clinical trial team can contact you directly.
  

bjjww

简单翻一下


1，直接联系临床试验工作队。PI--首席研究员--是大头，不管事，管事的是“trial coordinator,”--临床试验协调员， the “referral coordinator,” or the “protocol assistant”. 和他们说你的病情，他们就能判断你能否参与。

2。会有很多病情的问题要回答，所以找你的医生或熟悉你们病情的人给他们打电话。临床试验协调员会询问你的癌症诊断和目前的一般健康问题，您可能要问您的健康照护团队来为您联系的临床试验团队

3。通过网络连接，或给他们电话，让他们回电，这样的临床试验团队可以直接与您联系。

good luck！

bjjww

Step 8: Ask Questions About the Trial

无论你或你的医疗保健小组联系临床试验团队，这是个不错的时机来问问题，这将有助于您决定是否参加这一特殊的临床试验的一部分答案。
  
这将是有益的，如果你能谈谈你的CA和你目前的状况。
  
在您拨打电话，您可能要排练怎么提供有关你的癌症诊断与家人或朋友一般健康的关键信息。

当你对临床试验小组的成员说，它会帮助你回答他或她的问题，更顺利。

应该问临床试验团队的问题。

1还招人吗？
2我合格吗？
3为什么这个药更有效？

4什么是潜在的风险和可能获得的治疗我在这次审判带来的利益？
每个治疗有风险，你是否接受，作为一个临床试验或从您的临床试验之外的医生治疗的一部分。确保你了解可能的风险和每个治疗，你可能会收到作为这项试验的参与者副作用。此外，要求一个如何处理您可能会收到您的详细描述可受益。

5。谁将会照看我的关心和安全？
为照顾和参与癌症临床试验的一部分人民的安全负有主要责任的临床试验小组。此外，临床试验是由安全及联邦政府和该组织发起并开展审讯伦理规范。这些群体之一是所谓的机构审查委员会（IRB）。审判小组将能够给你更多的信息。您还可以看到保护的临床试验的研究对象。

6。我可以得到一个试用的协议文件的副本？
试用的协议文件是为试验行动计划。它包括做试验的原因时，该会包括在内，参加的资格，将被给予治疗，将要完成，频率，以及哪些信息将被体检人数收集。这些文件通常用在高度技术语言，而且往往保密。在某些情况下，然而，审判工作队可获准释放的协议资料给你。


最后别忘了问----谁支付我的旅行和住宿？
临床试验很少支付旅费和食宿费用。不过，你还是应该问这个问题。

http://www.cancer.gov/clinicaltrials/education/treatment-trial-guide/page12

Whether you or someone from your health care team calls the clinical trial team, this is the time to get answers to questions that will help you decide whether or not to take part in this particular clinical trial.
It will be helpful if you can talk about your cancer and your current general health in a manner that is brief and to the point. Before you make the call, you may want to rehearse how you will present key information about your cancer diagnosis and general health with a family member or a friend. This will make you more comfortable when you are talking with the clinical trial team member, and it will help you answer his or her questions more smoothly.

Remember to keep your Cancer Details Checklist (from Step 3) handy to help you answer some of the questions that may be asked.你要保存你的病情的详细报告。

bjjww

Step 9: Discuss Your Options with Your Doctor

和你的医生讨论，三思而后行，权衡潜在风险和受益，和你的医生讨论参与和不参与的利弊。

自己拿主意。

To make a final decision, you will want to know the potential risks and benefits of all treatment options available to you. Through the research that you have done, you likely have a good idea about the possible risks and benefits of the treatment(s) in clinical trials that interest you. If you have any remaining questions or concerns, you should discuss them with your doctor. You should also ask your doctor about the risks and benefits of standard, or usual, treatment for your type of cancer. Then, you and your doctor can compare the risks and benefits of standard treatment with those of treatment in a clinical trial. You may decide that joining a trial is your best option, or you may decide not to join a trial. It’s your choice.

bjjww

个人建议：1期是测试安全性---safety 和剂量确认---dose finding. 要权衡利弊。这一期，风险最大。

象双刃剑。

自己拿主意

射频后拉米

新药首先要确保安全性，即剂量大小，国人与外种人在身高体重上总有差异，

bjjww

射频后拉米 发表于 2011-5-7 14:24
新药首先要确保安全性，即剂量大小，国人与外种人在身高体重上总有差异， ...

这些都有考虑。

日剑

wkx323

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该实验组的电话留一个在这里，这个备忘录就更完美了，呵呵