- Clinical Trials: What You Need to Know
- Why do we need clinical trials?
- What happens before a clinical trial starts?
- Some facts about clinical trials 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
- How are study participants protected?
- 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?
- Private insurers and the new health care law
- What would it be like to be in a clinical trial?
- What if I’m not eligible for a clinical trial?
- Summing it all up
- To learn more
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 trials 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 submitted to the Food and Drug Administration (FDA) and to an institutional review board (IRB) to get the approval needed 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 (such as names and doses of drugs to be used in the study), often including results of studies done before
- The phase of the study and how many people will be in it
- Who is eligible for the study
- How the treatment is to be given
- What tests will be done during the study and how often they’ll be done
- Other information that will be collected on participants
- How long the study will last
Actual study protocols can be very long, 100 pages or more, and they can be very technical. Because they aren’t written with patients in mind, making sense of them isn’t always easy.
The clinical trial lists available online often include summaries of these protocols, 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 on the new treatment.
Eligibility, or inclusion and exclusion criteria
All clinical trials have guidelines about who can be in them. Anyone who wants to take part must fit the guidelines. For instance, some studies are looking for volunteers with a certain type of cancer, or a certain stage of disease, while others are looking for people who have just been diagnosed and haven’t had any cancer treatment yet. The factors that allow a person to sign up for a study are called inclusion criteria. To take part in the study, a person has to meet the requirements on this checklist.
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 can’t take part in a study, as can taking certain drugs. Factors that disqualify people from taking part are called exclusion criteria. These criteria are often used to be sure that the people in the study can safely take part.
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 and confirmed you’re eligible for it, deciding if it’s the right one for you can still be hard. There may even be more than one study 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 the clinical trials you’re 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 might need to make a special appointment to allow your doctor enough time to look over the information.
You might also want to get a second opinion from a doctor not connected to the studies you’re 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.
Finally, talk to friends and family members you trust. Although the final decision is yours, their opinions may give you insight into things you hadn’t thought about.
Last Medical Review: 09/25/2014
Last Revised: 10/31/2014