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Questions About Trials and Profiles

Choosing to participate in a clinical trial is an important personal decision. The following questions provide detailed information about participating in clinical trials. In addition, it is often helpful to talk to a physician, family members, or friends about deciding to join a trial. After identifying some trial options, the next step is to contact our Help us Discover team to find out more about what trials are occurring at Yale and to contact the study research staff and ask questions about specific trials. Email us at helpusdiscover@yale.edu or call 1-877-978-8343.


Trials

What is a clinical trial?
Although there are many definitions of clinical trials, they are generally considered to be biomedical or health-related research studies in human beings that follow a pre-defined procedure.
What happens during a clinical trial?
The clinical trial process depends on the kind of trial being conducted. The clinical trial team includes doctors and nurses as well as social workers and other health care professionals. They check the health of each participant at the beginning of the trial, give specific instructions for participating in the trial, monitor each participant carefully during the trial, and stay in touch after the trial is completed. Some clinical trials involve more tests and doctor visits than you would normally have for an illness or condition. For all types of trials, you will work with a research team. Clinical trial participation is most successful when the protocol is carefully followed and there is frequent contact with the research staff.
Where do the ideas for trials come from?
Ideas for clinical trials usually come from researchers. After researchers test new therapies or procedures in the laboratory and in animal studies, the experimental treatments with the most promising laboratory results are moved into clinical trials. During a trial, more and more information is gained about an experimental treatment, including its risks and how well it may or may not work.
Why should I participate in a trial?
There are many reasons why people volunteer to take part in a clinical trial:
  • Some volunteers have a condition that is being treated effectively but want to help doctors find out more about it in order to develop new treatments.
  • Sometimes volunteers have a friend or loved one with an illness or injury and they want to participate in a research study as a way of helping that person and others who may suffer from the same condition.
  • It may be that there is no effective treatment for an illness or injury or the existing treatment has harsh side effects. Participating in a clinical trial may offer potential treatment options that might otherwise be unavailable.
  • Many people choose to participate in a study even though it might not be able to help them directly. Knowing that others may be able to benefit from their efforts is a rewarding experience.
  • Sometimes people volunteer because they are compensated for their time and effort.
Who can participate in a trial?
All clinical trials have guidelines about who can participate. The use of these guidelines is an important principle of medical research that helps to produce reliable results. The factors that allow someone to participate in a clinical trial are called "inclusion criteria" and those that prevent someone from participating are called "exclusion criteria". These criteria are based on factors such as age, gender, the type and stage of a disease, previous treatment history, and other medical conditions. It is important to note that inclusion and exclusion criteria are not used to reject people personally. Instead, the criteria are used to identify appropriate participants and keep them safe. The criteria help ensure that researchers will be able to answer the questions they plan to study.
Do I have to have an illness to participate in a clinical trial?
While some research studies seek participants with illnesses or conditions to be studied in the clinical trial, it is not always necessary to have a specific illness or condition to participate. In fact, there are many trials that need healthy volunteers. Participants who are healthy are often needed to provide information that can be compared with people who have a particular disease.
What are the benefits and risks of participating in a clinical trial?
Benefits

Clinical trials that are well-designed and well-executed are the best approach for eligible participants to:

  • Play an active role in their own health care.
  • Gain access to new research treatments before they are widely available.
  • Obtain expert medical care at leading health care facilities during the trial.
  • Help others by contributing to medical research
Risks

As with most medical treatments, there may be some risks to participating in a clinical trial. Possible risks include the following:

  • Your participation may require more time and attention than routine clinical care. This may involve visits to the study site, phone calls from the study doctor or staff, frequent treatments or procedures, answering questions, a hospital stay or a more complicated drug regimen.
  • The treatment or procedure may not be effective for every individual.
  • There may be unpleasant, serious or even life-threatening side effects when undergoing experimental treatments.
What are side effects and adverse reactions?
Side effects are any undesired actions or effects of the experimental drug or treatment. Negative or adverse effects may include headache, nausea, hair loss, skin irritation, or other physical problems. Experimental treatments must be evaluated for both immediate and long-term side effects.
What should I consider before participating in a trial?

You should know as much as possible about the clinical trial and feel comfortable asking the members of the health care team questions about it, the care expected while in a trial, and the cost of the trial. The following questions might be helpful for you to discuss with the health care team.

Some of the answers to these questions are found in the informed consent document.

  • What is the purpose of the study?
  • Who is going to be in the study?
  • Why do researchers believe the experimental treatment being tested may be effective? Has it been tested before?
  • What drugs, devices, procedures, tests, examinations and visits are required in order to participate?
  • What are the potential risks of this trial?
  • What are the expected benefits to me if I participate?
  • How do the possible risks, side effects, and benefits in the study compare with my current treatment?
  • Will I have to change my daily activities or diet if I participate?
  • How long will the trial last?
  • Will hospitalization be required?
  • Who will pay for the experimental treatment?
  • Will I incur any costs?
  • Will I be reimbursed for expenses or paid for my participation?
  • What type of long-term follow up care is part of this study?
  • How will I know that the experimental treatment is working? Will results of the trials be provided to me?
  • Who will be in charge of my care?
  • Whom should I contact if I have questions about the trial?
  • Are there other clinical trials for which I might be eligible?

Some of the ways to determine if a clinical trial is right for you include:

  • Comparing the reason why you're interested in participating to the question the trial hopes to answer. You should think about whether the trial has the potential to fulfill your hopes and expectations. You should also weigh the potential risks and benefits of participating in the trial.
  • Informing yourself about the questions the trial is trying to answer by researching on your own through reputable websites and the library and by asking questions. You may also want to talk to your family, friends or your personal physician.

YCCI staff members, study doctors, nurses and coordinators are available to answer your questions so that you can make an informed decision

What should I do to prepare when meeting with the research coordinator or doctor?
  • Plan ahead and write down possible questions to ask.
  • Ask a friend or relative to come along for support and to hear the responses to the questions.
  • Bring a tape recorder to record the discussion to replay later.
How is my safety protected?

The ethical and legal codes that govern medical practice also apply to clinical trials. Most clinical research is federally regulated with built in safeguards to protect the participants. For example, every clinical trial in the U.S. must be approved and monitored by an Institutional Review Board (IRB) to make sure the risks are as low as possible and are worth any potential benefits. An IRB is an independent committee of physicians, statisticians, community advocates, and others that ensures that a clinical trial is ethical and the rights of study participants are protected. All institutions that conduct or support biomedical research involving people must, by federal regulation, have an IRB that initially approves and periodically reviews the research. In addition, all trials follow a carefully controlled protocol, a study plan which details what researchers will do in the study. As a clinical trial progresses, researchers report the results of the trial at scientific meetings, to medical journals, and to various government agencies. Individual participants' names will remain secret and will not be mentioned in these reports.

Who pays for clinical trials? Are there any costs to me?

Clinical trials are sponsored or funded by a variety of organizations or individuals such as physicians, medical institutions, foundations, voluntary groups, and pharmaceutical companies, in addition to federal agencies such as the National Institutes of Health (NIH), the Department of Defense (DOD), and the Department of Veteran's Affairs (VA).

The sponsor of the research usually pays for all research-related costs. If a study involves routine tests, treatments or procedures that you would normally undergo as part of the standard course of treatment for your condition, then you or your insurance company may be asked to cover these fees. Before the trial begins, be sure to ask the trial staff which fees may be billable to you or your insurance company.

Read more about financial responsibilities associated with participation in a research study.


Should I continue to work with a primary health care provider while in a trial?
Yes. Most clinical trials provide short-term treatments related to a designated illness or condition, but do not provide extended or complete primary health care. In addition, by having the health care provider work with the research team, the participant can ensure that other medications or treatments will not conflict with the protocol.
Can I leave a clinical trial after it has begun?
Yes, you can leave a clinical trial, at any time. When withdrawing from the trial, you should let the research team know about it, and the reasons for leaving the study. Some of this information is copyright of the U.S. National Library of Medicine