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 YCCI to find out more about what trials are occurring at Yale and to contact the study research staff and ask questions about specific trials.

Trials

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.

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.

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.

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.

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.

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.

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.

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.

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.

  • 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.

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.

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.

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.

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

Creating A Profile

How do I create a profile?

To create a profile, click on the 'create a profile' link on any page of this website and fill out your information. When you click the submit button, your profile will be created.

Will I be able to edit my profile once I create it?

Yes. You can edit your profile at any time by logging in to your profile and clicking on the 'Edit Your Profile' tab. Any changes you make will be updated in our system automatically.

I forgot my password. How do I retrieve it?

To reset your password, click on the 'Lost Password' link on the login page of this website and enter your email address. A temporary password will be sent to you, which you will be required to change the next time you log in to the Clinical Research at Yale website.

I would rather be contacted by phone than by email. Should I still create a profile?

Yes. Your profile includes an area where you can specify a preferred method of contact. You can choose between being contacted by phone or email. You can change your preferred method of contact anytime by clicking on the 'Edit Your Profile' tab of your profile.

How do I temporarily stop being contacted about studies?

To temporarily stop being contacted about studies, log in to your profile, click the 'Edit Your Profile' tab and check the check box under 'Temporarily Opt Out.' You will be asked to specify a period of time during which you will not be contacted about any studies. At the end of that period, you will automatically be opted back in.

Can I delete my profile?

Yes. To delete your profile, log in to your profile and click on the 'Edit Your Profile' tab. At the bottom of the page, you will see a 'delete your profile' link. Click on that link to delete your profile.

When you delete your profile, all of your personal information and any trials or trial categories you selected will be removed from the Yale Clinical Research website and the systems that support it. If you choose to create a profile again, you will need to re-enter all of your profile information.

How will my information be used? / How does the profile system work?

When I express interest in a trial or trial category, how is my information used?

When you express interest in a specific study, the information from your profile will be sent to the doctor conducting that study. If you're eligible to participate, you may be contacted by a nurse or study coordinator. If you select a health category rather than a specific study, doctors who have active studies in that area may contact you to ask if you would like to participate. In both cases, you will be contacted by the preferred method (e-mail or phone) that you specified in your profile.

What If I change my mind and decide I am not interested in participating in a study or study category in which I expressed interest?

You can change your study categories at any time by logging in to the profile system and clicking on the 'Edit Your Profile' tab of your profile. When you do, be sure to click the 'save' button at the bottom to save your preferences. To remove studies from your list of studies, click on the 'View My Studies' tab and click the remove button.

Does adding a study to my list of studies guarantee that I will have the chance to participate?

Every trial has eligibility criteria that are used to make sure participants are suited to the study. We have provided a basic list of eligibility criteria, but there may be other factors to consider. The doctor, nurse, or study coordinator may ask you additional questions to make sure the study is right for you. Even if it's not, you may be eligible for other studies.

How will you my address be used?

We may send you information about research findings, new studies, or other items related to clinical research at Yale. Your address is also provided to the doctor or study coordinator.

Why does the profile registration page ask about my race? How will that information be used?

We ask about race or ethnicity because some trials are looking for specific characteristics in participants. This is because some conditions may be more common in those with a particular ethnic background or may affect them differently. Also, in order to receive funding from the federal government, we are required to make sure that research studies include a variety of groups, such as women and minorities, where appropriate.

Who will contact me?

A member of the study coordination team will contact you.

How long will it take for me to be contacted once I register?

Once you are registered, the ability to match to a trial is immediate. There is also the possibility that you will not qualify for any studies at this time. Therefore, a period of time may pass before you are matched to a trial and contacted by a member of a particular study team.

Will I be required to participate in a trial if I am contacted? Can I change my mind?

Participating in a clinical trial is always your decision. You can change your mind about participating at any time. If you decide to withdraw in the middle of a trial, you should let the research team know about it and the reasons why, because it is important for them to know about any side effects you may have experienced. Also, it may be necessary to gradually stop taking any medications you have been given.

Questions about Privacy

Who will be able to see my profile information? Will google be able to see my profile?

The Yale doctor and research staff affiliated with specific studies in which you expressed interest or those who are conducting studies in categories that interest you will be able to see your profile information. Just as when you visit your doctor, all health care providers and research staff at Yale are subject to HIPAA (Health Insurance Portability and Accountability Act) and are therefore required to protect the privacy and confidentiality of your information.


Internet search engines such as Google, Bing and Yahoo will not be able to see or index your information.

How will my privacy be protected?

We will keep your information confidential and secure as required by state and federal law. We will keep the information that you provide indefinitely until and if you delete it. If you decide that you do not wish to participate in the database any more, you can delete your information any time by clicking the 'delete your profile' link at the bottom of the edit tab of your profile.

Additional Questions

What if I have additional questions?

Please feel free to ask about anything you don't understand and to consider participation in the research database and the consent form carefully - as long as you feel is necessary - before you make a decision. Questions about the database should be made to Kristin by calling 1-877-YSTUDIES (97883437).

If you have any questions concerning your rights as a research volunteer, you may contact the Human Investigation Committee at (203) 785-4688. If you have any questions about your privacy rights, please contact the Yale Privacy Officer at (203) 436-3650.

If you have any questions about participating in clinical trials, you may also wish to read our Clinical Trials FAQ.