- Clinical Trials: What You Need to Know
- Why do we need clinical trials?
- What happens before clinical trials?
- Some facts about clinical trials: Important points to keep in mind
- What are the phases of clinical trials?
- Phase 0 clinical trials: Exploring if and how a new drug may work
- Phase I clinical trials: Is the treatment safe?
- Phase II clinical trials: Does the treatment work?
- Phase III clinical trials: Is it better than what’s already available?
- Submission for FDA approval: New drug application (NDA)
- Phase IV clinical trials: What else do we need to know?
- Who sponsors and runs clinical trials?
- Should I think about taking part in a clinical trial?
- Answers to some common questions about clinical trials
- Other questions you should ask your research team
- What protects the study participants?
- What’s out there? Finding clinical trials
- How do I figure out which study is for me?
- What about cost? Will my insurance cover it?
- What would it be like to take part in a clinical trial?
- What if I’m not eligible for a clinical trial?
- Summing it all up
How do I figure out which study is for me?
Whether your doctor suggests a certain clinical trial or you use the available lists or matching services on the Web, how do you know which study makes the most sense for you?
You could be eligible for several studies at the same time. There may be obvious reasons for not choosing some, such as those that are being done too far away from where you live, but with others the choice may not be so clear. Understanding what each study involves can help you make your decision.
The study protocol
The study protocol is the written plan for how a clinical trial is to be conducted. It’s what is submitted to the FDA and to an institutional review board (IRB) before a new treatment can be studied. A protocol contains the following information:
- Why the study is being done (including the goals of the study)
- Information about the treatment being tested, often including results of studies done before
- The phase of the study and how many people will be enrolled
- Who is eligible for the study
- How the treatment is to be given
- What tests will be done during the study and how often
- Other information that will be collected on participants
Actual study protocols can be as long as100 pages or more, and they can be very technical. Because they are not written with patients in mind, making sense of their language isn’t always easy.
The clinical trial lists available on the Web often include summaries of these protocols, just highlighting some key points. Research team members may also have protocol summaries or other information about the study they can share with you. Often, the most important information for patients looking for studies is the eligibility criteria (see below) and any information available about the new treatment.
Eligibility, or inclusion and exclusion criteria
All clinical trials have guidelines about who can take part. Anyone who wants to take part must fit the guidelines to be in the study. For instance, some studies are looking for volunteers with a certain type of illness, or a certain stage of disease, while others are looking for healthy volunteers. Some studies look for people who have been treated for their illness, and others look for people who have not. The factors that allow a person to sign up for a study are called inclusion criteria. In order to take part in the study, a person has to have all the factors on this checklist. These criteria are used to help be sure that the researchers will be able to answer the questions they plan to study.
There are also factors that can exclude a person from each study. For example, a study may be looking for people of a certain age, so people older and younger would not be able to take part. Having certain medical conditions may mean that you cannot take part in a study, as can taking certain drugs. Factors that disqualify people from taking part are called exclusion criteria. In order to take part in the study, a person cannot have any of the factors on this checklist. These criteria are often used to be sure that the people in the study can safely take part. They also help make sure that the researchers will be able to answer their questions.
For cancer clinical trials, the inclusion and exclusion criteria usually have to do with:
- The type of cancer a person has
- The stage (extent) of the cancer
- Previous treatments a person had
- The length of time since a person last received treatment
- Results of certain lab tests
- The medicines a person is taking
- Other medical conditions the person has
- Any previous history of another cancer
- A person’s activity level (also known as performance status)
Other factors, such as a person’s age or sex, may also be part of the criteria. There are usually other criteria for each study, as well.
Advertisements and clinical trial lists may not contain all of a study’s eligibility criteria. If you’ve found a study you think you might qualify for, you can usually contact someone involved with the study to get a full list of the criteria.
I think I’m eligible. Now what?
Once you’ve found a study that you’ve confirmed you’re eligible for, deciding if it’s the right one for you can still be hard. There may even be more than one that looks promising. Again, it’s important to learn as much as you can.
Talk with someone connected to the study. This could be the clinical investigator or principal investigator (PI) – the person in charge of the study – or a research coordinator. Research coordinators are usually nurses. One of their jobs is to make sure that people meet eligibility criteria before they get into a study. They also make sure that the study protocol is followed for each patient. They often serve as a link between study patients and their doctors.
Both PIs and research coordinators should be able to answer your questions about the study. See the section “Should I think about taking part in a clinical trial?” for a list of questions you might want to ask. They can give you answers about their particular clinical trial, but they are not likely to be helpful in discussing other studies you might be thinking about. What’s more, they could be biased (even if they don’t mean to be) toward their own study.
If you haven’t done so already, talk to your doctor about clinical trials you are looking at. Bring in whatever information you can, so that your doctor can help you figure out what might be right for you. No doctor knows about every clinical trial being done, but your doctor knows your medical situation best and can probably tell you if the study is worth considering. This discussion can take some time, so you may need to make a special appointment to allow your doctor enough time to look over the information you provide.
You might also want to get a second opinion from a doctor not connected to the studies you are looking at. Doctors who are well known in their fields usually know about the latest experimental treatments, and they may be able to point to those that look more promising.
If you have access to the Internet, you can find some information on your own. Try to find out if the new treatment has been studied before or if it’s being studied now in other diseases, as well as whether any results are available. If this is hard for you, have someone close to you help or do it for you. People with a medical background may have an easier time sorting through such information.
Finally, talk to friends and family members you trust. Although the final decision is yours, their opinions may give you insight into things you had not thought about.
Last Medical Review: 09/21/2012
Last Revised: 09/21/2012