什么是癌症临床试验?

癌症临床试验, 也被称为癌症治疗或癌症研究, 在癌症患者身上测试新的治疗方法. The goal of this research is to find better ways to treat cancer and help cancer patients. Clinical trials test many types of treatment such as: new drugs; new approaches to surgery or radiation therapy; new combinations of treatments; or, new methods, such as gene therapy.

A cancer clinical trial is one of the final stages of a long and careful research process. 寻找新的治疗方法始于实验室, 科学家首先在哪里开发和测试新想法. 如果一种方法看起来很有希望, the next step may be testing a treatment in animals to see how it affects cancer in a living being and whether it has harmful effects. Of course, treatments that work well in the lab or in animals do not always work well in people. Studies are done with cancer patients to find out whether promising treatments are safe and effective.

癌症临床试验包括三个不同阶段的研究. 每个阶段回答有关新疗法的不同问题.

• 第一阶段试验是在人类身上测试新疗法的第一步. In these studies, researchers look for the best way to give an experimental drug (e.g., by mouth, IV drip, or injection; how many times a day). 他们还试图找出是否以及如何安全地进行治疗.g.(最佳剂量)，并注意任何有害的副作用. 因为我们对第一阶段可能的风险和收益知之甚少, these studies usually include only a limited number of patients who would not be helped by other known treatments.
• Phase II trials focus on learning whether the experimental drug has an anticancer effect (e.g.它能缩小肿瘤吗? 改善血液检查结果?). As in Phase I, only a small number of people take part because of the risks and unknown variables involved.
• Phase III trials compare the results of people taking the experimental drug with the results of people taking standard treatment (e.g.哪一组存活率更高? Fewer side effects?). In most cases, studies move into Phase III testing only after a drug shows promise in Phases I and II. 第三阶段的试验可能包括全国数百人. Comparing similar groups of people taking different treatments for the same type of cancer is another way to make sure that study results are real and caused by the treatment, rather than by chance, or other factors. Comparing treatments with each other often shows clearly which one is more effective and/or has fewer side effects.

为什么临床试验很重要?

临床试验的重要性体现在两个方面. First, cancer affects us all, whether we have it, 关心那些关心你的人, 或者担心将来会得到它. 临床试验有助于对癌症的认识和进步. 如果一种新的治疗方法在研究中证明有效, 它可能成为一种新的标准治疗方法，可以帮助许多患者. Many of today's most effective standard treatments are based on previous study results, 比如乳房, colon, rectal, and childhood cancers.

Clinical trials may also answer important scientific questions and suggest future research directions. 因为通过临床试验取得的进展, 许多接受癌症治疗的人现在活得更长了.

Second, the patients who take part may be helped personally by the treatment(s) they receive. 他们从癌症专家那里得到最新的治疗, and they receive either a new treatment being tested or the best available standard treatment for their cancer. Of course, there is no guarantee that a new treatment being tested or a standard treatment will produce good results. 新的治疗方法也可能有未知的风险.

But, 如果一种新的治疗方法被证明有效, or more effective, 比标准治疗方法, 接受它的研究患者可能是第一批受益的患者. 许多接受标准治疗的患者从中受益.

In the past, clinical trials were sometimes seen as a last resort for people who had no other treatment choices. Today, patients with common cancers often choose to receive their first treatment in a clinical trial.

你的权利，你的保护

在癌症治疗研究之前和期间，你有很多权利. 了解这些可以帮助你免受伤害.

是否参加治疗研究取决于你. 这可能只是你的治疗选择之一. Talk with your doctor. 一起，你可以为你做出最好的选择.

如果你参加了一个研究, doctors and nurses will follow your response to treatment carefully throughout the research.

If researchers learn that a treatment harms you, you will be taken off the study immediately. 然后你可以从你自己的医生那里接受其他治疗. 你有权在任何时候离开研究.

你的关键权利之一是知情同意权. Informed consent means that you must be given all the facts about a study before you decide whether to take part. This includes details about the treatments and tests you may receive and the possible benefits and risks they may have.

The doctor or nurse will give you an informed consent form that goes over key facts. If you agree to take part in the study, you will be asked to sign this informed consent form.

知情同意过程贯穿整个研究过程. For instance, you will be told of any new findings regarding your clinical trial, such as new risks. 如果您想继续参与研究，您可能会被要求签署一份新的同意书.

签署同意书并不意味着您必须留在研究中. 事实上，你可以随时离开. 如果你选择离开书房, you will have the chance to discuss other treatments and care with your own doctor or a doctor from the study.

谁有资格参加?

Each study has its own guidelines for who can participate, called eligibility criteria. Generally, 一项研究的参与者在关键方面是相似的, 比如癌症的类型和阶段, age, gender, or previous treatments. 资格标准包含在学习计划中. 看看你是否有资格参加某项研究, talk to your doctor or the doctor or nurse in charge of enrolling patients in the study.

The Pros and Cons

虽然临床试验对某些人来说是一个不错的选择, 这种治疗方案可能有缺点，也有潜在的好处. 这里有一些需要考虑的因素. 你可能想和你的医生和你身边的人讨论一下.

Possible Benefits

临床试验提供高质量的癌症治疗. 如果您正在研究中，并且没有收到正在测试的实验选项, 你会得到最好的标准治疗. 这可能和新方法一样好，甚至更好. 如果一个实验性的选择被证明是有效的，你正在采取它, 你可能是最先受益的人之一.

By looking at the pros and cons of clinical trials and your other treatment choices, 你在一个影响你生活的决定中扮演着积极的角色.

你有机会帮助他人，改善癌症治疗.

Possible Drawbacks

Experimental options under study are not always better than, or even as good as, standard care. They may have side effects that doctors do not expect or that are worse than those of standard treatment.

即使一种实验性药物有好处，它也可能对你不起作用. Even standard treatments, proven effective for many people, do not help everyone.

If you receive standard treatment instead of the experimental one being tested, 它可能不如新方法有效.

Health insurance and managed care providers do not always cover all patient care costs in a study. 他们所涵盖的内容因计划和学习而异. 提前了解在你的情况下可能需要支付哪些费用, talk to a doctor, 研究中的护士或社工.

谁来支付推荐十大正规网赌平台的护理费用?

即使你有健康保险, your coverage may not include some or all of the costs associated with a clinical trial. This is because some health plans define clinical trials as "experimental" or "investigational" procedures. However, they may be willing to pay if the experimental option is similar to a standard treatment. Because lack of coverage for these costs can keep people from enrolling in trials, the National Cancer Institute is working with major health plans and managed care groups to find solutions.

*来源:美国国家癌症研究所