FAQ – Frequently Asked Questions

The terminology used throughout the clinical trial process can be overwhelming. In order to simplify the process we’ve collected some common questions people have about Clinical Research in general. Below is a list of resources that are also helpful for those considering participating in a clinical research study.

What is a clinical trial?

A clinical trial is a research study in human volunteers that seeks to answer specific health questions. Carefully conducted clinical trials are the fastest and safest way to find treatments that work in people and ways to improve health. Interventional trials determine whether experimental treatments or new ways of using known therapies are safe and effective under controlled environments. Observational trials address health issues in large groups of people or populations in natural settings.

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 the participant at the beginning of the trial, give specific instructions for participating in the trial, monitor the participant carefully during the trial, and stay in touch after the trial is completed.

Some clinical trials involve more tests and doctor visits than the participant would normally have for an illness or condition. For all types of trials, the participant works 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.

What is informed consent?

Informed consent is the process of learning the key facts about a clinical trial before deciding whether or not to participate. It is also a continuing process throughout the study to provide information for participants. To help someone decide whether or not to participate, the doctors and nurses involved in the trial explain the details of the study. If the participant’s native language is not English, translation assistance can be provided. Then the research team provides an informed consent document that includes details about the study, such as its purpose, duration, required procedures, and key contacts. Risks and potential benefits are explained in the informed consent document. The participant then decides whether or not to sign the document. Informed consent is not a contract, and the participant may withdraw from the trial at any time.

How is the safety of the participant protected?

The ethical and legal codes that govern medical practice also apply to clinical trials. In addition, most clinical research is federally regulated with built in safeguards to protect the participants. The trial follows 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.

Does a participant 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 a participant leave a clinical trial after it has begun?

Yes. A participant can leave a clinical trial, at any time. When withdrawing from the trial, the participant should let the research team know about it, and the reasons for leaving the study.

Helpful Resources

Research Glossary

Would you like to learn the terminology that you may see throughout the research process? Center Watch is an excellent source for this information.

http://centerwatch.com/health-resources/glossary/

Understanding the Informed Consent

Outweighing the risks from benefits in a research trial can be a tough decision. CenterWatch has additional information that helps explain the informed consent used in clinical trials.

http://centerwatch.com/clinical-trials/understanding-informed-consent.aspx

More About Clinical Studies:

For more information about studies that are currently enrolling and more about clinical research in general, visit Clinicaltrials.gov

http://clinicaltrials.gov/ct2/about-studies/learn

For any additional questions please contact us and a team member will be in touch with you shortly!

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