在本文中，你将了解到：
作为患者，如何决定是否参加新药临床试验。
感谢我读研时的班长刁世勇博士，这篇文章是在他的建议下完成的。初稿完成后，刁博士给出了建设性的意见。
本文有中文和英文双语两个版本。前面是中文，后面是英文。
在医院就医期间，医生可能会询问你，是否愿意参加新药临床试验。
是否参加新药临床试验，你要多方面考虑。
比如，药物可能的副作用，药物可能有多大的效果，以及为了配合临床试验需要投入的时间。
下面的内容，有助于你做出正确的决定。
一、什么是临床试验？
临床试验，是在人体中测试新疗法的人体研究。其目的是为了验证新的疗法是否安全和有效。
新药获批上市前，临床试验通常分为三期。
临床试验1期，新药首次应用于人体。
1期试验的目的是评估治疗的安全性，如新药的剂量限制毒性。
开展临床1期试验要经过药监局的严格审批，获批后通常称之为IND（investigational new drug）。
应用于人体的药品，首先是安全性，其次才是有效性。
例如能高效杀死肿瘤的研究药物，体外试验可能疗效很强大，但是如果安全性差，就不会被获批进入临床试验阶段。
临床试验2期，是在1期剂量探索的基础上，扩大受试者数据，验证新药的有效性和安全性。
临床试验3期，通常是在2期疗效和安全性发现的基础上，在更大规模人群、对更具说服力的疗效和安全性指标进行进一步验证。如果确证疗效和安全性优于目前的标准治疗，就可以向药监局申请获批上市。
临床试验2期和3期通常会设计为双盲、对照临床研究。医生和患者都不知道患者服用的是研究药物还是对照药物（对照药物通常是目前临床上的标准治疗）。
二、参加临床试验有哪些好处
参加新药的临床试验有许多潜在好处。
第一，有机会获得尚未向公众开放的最新疗法的救治。
第二，治疗过程受到一个专业医疗团队的密切监测。
这意味着，如果你经历了治疗过程中的任何副作用，它们将被及早发现，你能够得到尽可能好的护理。
第三，获得免费治疗。
除了用于治疗的试验药物免费，住院费、检查费、不良事件的治疗费等都是免费的，而且会给与一定的交通补贴。这可以帮你节约一笔不小的医疗费用。
第四，帮助推动创新疗法的开发。
从临床试验中收集的数据，对于研究人员了解新疗法如何发挥作用，以及它们是否安全和有效至关重要。
通过参与临床试验，你可以帮助改善未来患者的治疗。
三、参加临床试验的缺点
参加癌症新药的临床试验也有一些潜在的缺点。
第一，不能保证治疗的有效性
临床试验的目的是测试一种新的治疗方法是否安全和有效，但有时在早期动物试验中看起来很有希望的治疗方法，在更大的试验中却没有效果。
第二，可能要耗费很多额外时间
有些试验需要多次到医院或诊所进行治疗和复诊。这对那些日程安排繁忙或居住地远离试验地点的人来说可能很困难。
第三，发生副作用的风险。
虽然药物在递交临床试验申请之前都已必须完成体外试验和动物体内试验，以验证过其安全性和有效性。但是毕竟绝大部分动物试验都是来自于小鼠，而小鼠与人还是很大差别，对动物安全和有效的药物，临床试验可能会发现副作用很大。
如果在临床试验中你发生了新疗法的副作用，研究医生将对其进行密切监测。
四、做出决定
是否参加临床试验，要权衡利弊，并与医生讨论你的决定。
如果你正在考虑参加临床试验，你可以做如下一些准备工作。
首先，尽可能多地了解你所感兴趣的临床试验。
阅读知情同意书中的临床试验细节和你作为参与者的权利。
你也应该咨询你的医生有关临床试验的任何问题和担心。
第二，与家人和朋友讨论参加临床试验的决定
家人和朋友可能会提出你没有考虑过的问题或担忧。在你做出决定之前，得到他们的支持是很重要的。
第三，确保你有一个良好的支持系统
参加临床试验可能会耗费额外的时间，还要面对疾病带来的压力。拥有一个由家人和朋友组成的支持性网络可以帮助你度过这个过程。
需要提醒的是，作为志愿者，你有权力随时退出临床试验。
Making the decision to participate in aclinical trial for a new drug can be difficult. There are many things to be considered, such as the possible side effects of the drug, how effective the drug may be, and the time commitment required.
Here are some things to keep in mind that may help you make a decision.
What is a clinical trial?
A clinical trial is a research study that tests a new treatment in humans. Clinical trials are conducted to find out whether new treatments are safe and effective.
Clinical trials are conducted in 3 phases.
In Phase I trials, researchers test a new treatment in a small group of people for the first time. The purpose of Phase I trials is to evaluate the safety of the treatment, as well as the side effects.
Phase II trials test the effectiveness of the new treatment in a larger group of people.
Phase III trials compare the new treatment with the current standard treatment.
The Pros of Participating in a Clinical Trial
There are many potential benefits to participating in a clinical trial for a new drug.
One of the most important is that you may be able to access a treatment that is not yet available to the general public. This means you could get access to the latest and most innovative treatments available.
Another benefit of clinical trials is that you will be closely monitored by a team of medical professionals.
This means that if you do experience any side effects from the treatment, they will be caught early and you will be able to receive the best possible care.
Treatment related to clinical trials is free of charge.
In addition to the trial drug used for treatment being free of charge, hospitalization fees, examination fees, and treatment fees for adverse events are all free of charge, and a travel allowance is given. This can help you save a significant amount of money on medical expenses.
Finally, participating in a clinical trialcan help contribute to the advancement of cancer treatment.
The data collected from clinical trials is essential for researchers to understand how new treatments work and whether they are safe and effective. By participating, you could be helping to improve the treatments available for future patients.
The Cons of Participating in a Clinical Trial
There are also some potential drawbacks to participating in a clinical trial for a new cancer drug.
One of the biggest is that there is no guarantee that the treatment will be effective. The goal of clinical trials is to test whether a new treatment is safe and effective, but sometimes treatments that look promising in early trials turn out not to be effective in larger trials.
Another downside of clinical trials is that they can be time-consuming.
Some trials require multiple visits to the hospital or clinic for treatment and follow-up appointments. This can be difficult for people who have busy schedules or who live far from the trial site.
Finally, there is always the risk of side effects when taking any new medication.
While researchers do their best to screen for potential side effects before a drug is approved for use, there is always the possibility that something could go wrong. If you do experience side effects from a new treatment, they will be closely monitored by the trial team, but you should be aware of this risk before you decide to participate.
Making a Decision
Making the decision to participate in aclinical trial is a personal decision that is different for everyone. It is important to weigh the pros and cons of participation and to discuss your decision with your doctor.
If you are considering participating in aclinical trial, there are a few things you can do to prepare.
First, you should learn as much as you can about the trial you are interested in.
This includes reading the informed consent form, which will explain the details of the trial and your rights as a participant. You should also ask your doctor any questions you have about the trial.
Second, you should talk to your family and friends about your decision to participate in a clinical trial.
They may have questions or concerns that you had not considered. It is important to get their support before you make a decision.
Finally, you should make sure you have agood support system in place.
Participating in a clinical trial can be time-consuming and stressful. Having a supportive network of family and friends can help you through the process.
It should be reminded that as a volunteer, you have the right to withdraw from the clinical trial at any time.
