What to expect before, during, and after the clinical trial
Your experience with a clinical trial goes through three phases:
- 审判前:知情同意
- 审判期间你的关心
- 审判结束后:学习结果
The following sections describe each of these phases.
审判前:知情同意
When you first meet with the research team, they will walk you through a process called "informed consent" to discuss:
- 研究的目的
- 所涉及的测试和程序
- 可能的风险和收益
- If there will be any costs to you
- How the researchers will protect your privacy
- Your rights as a participant in the trial
- 你可能有任何顾虑
You will be informed about new benefits, 风险, or side effects that may be discovered during the trial. You may also be asked to sign a new consent form that identifies these updates to the study.
Short-term 风险 are usually easy to identify. You'll see them outlined on your consent form. Long-term 风险 are often not well known because the drug or device hasn't been around long enough for the data to be available.
对团队的问题
Before joining a clinical trial, you'll probably have questions for your research team, such as:
- 谁赞助了这项研究?
- 这项研究的目的是什么?
- How do you determine if I'm eligible for this trial?
- Will I benefit from participating in this study?
- What are the 风险 if I choose to participate?
- What is the usual treatment for my condition?
- How different is this trial from that treatment?
- Does my participation affect the care that I will be receiving?
- What will be expected of me if I participate?
- How many times will I need to come to Dartmouth Hitchcock Medical Center?
- What will happen each time I am there?
- Will I be expected to pay for anything?
- Will my insurance be expected to pay for anything?
- 这项研究将持续多长时间?
- What happens to me when the study is over?
- What happens if I decide to leave?
We can't answer those questions now, 当然, 但是把他们带到你的团队中, along with any other concerns you have.
Be sure to remember that you are free to leave a trial at any point and that, 无论你的决定如何, you will receive the same comprehensive care at Dartmouth Hitchcock Medical Center.
试验期间:您的照顾
When you volunteer for a clinical trial, some visits and procedures collect information related only to the study. Other visits and procedures are part of the usual care, often referred to as "standard care,” for your condition which would be provided even if you were not in a clinical trial.
Being part of a clinical trial is not the same as being treated for a specific disease. Your routine care will continue with your regular health care providers while you take part in the research study. The important thing to remember is that the choice of whether or not to enter a clinical trial is completely up to you.
审判结束后:学习结果
Ask your research team if they know when the study will be completed and the results published. You can also see results of completed clinical trials at 临床试验.政府, a database run by the National Institutes of 健康.
记住, 虽然, that sometimes a trial needs to end before it is completed, or the trial is ongoing and does not have a specific end date.
确保您的安全
All trials through Dartmouth College, Geisel School of Medicine at Dartmouth, and Dartmouth Hitchcock Medical Center are conducted according to strict scientific and ethical principles.
每个临床试验都有一个计划, 称为协议, describing what will happen in the study and why it is necessary. 在审判开始之前, a committee reviews the protocol and approves it only if the clinical trial meets certain standards.
At 十大正规博彩网站评级正规博彩平台卫生, this group is called the Human 研究 Protection Program (HRPP). The committee evaluates the scientific basis for the trial, 参与者面临的风险, and the information participants receive.
The HRPP continues to oversee the study while it is in progress, and can stop a trial that does not meet their approval or is causing unexpected harm to participants. They also can halt a clinical trial if the treatment being studied is very effective, in order to make it available sooner to patients who are not on the trial.