Clinical Trials

Here are some initial steps you should consider when applying for a clinical trial:

• Consult with your healthcare providers to identify a clinical trial you are eligible for.
• Understand all the risks and benefits of participating in a clinical trial.
• Discuss any questions and concerns with your healthcare providers and research staff.
• Discuss with your family and friends the impact that participating in a clinical trial may have on your daily life.

If you have further questions, please review Information for Study Volunteers.

To ensure you have sufficient information about a particular clinical trial, know the answers to the following questions:

• What are the goals of the clinical trial?
• What will be required of me as a participant in the clinical trial?
• What are the risks, and how likely are they to occur?
• What will the researchers do to minimize the risks?
• What role will I play in the clinical trial?
• Will I likely benefit directly from the study?
• What are the potential benefits to others?
• How long is my participation required?
• What will my costs include?
• Do I really want to participate?
• Am I receiving compensation or other benefits for my participation?

To be eligible to participate in a clinical trial, you must meet the inclusion criteria. Make sure to discuss the eligibility criteria with your healthcare providers.

Here is what you should know about eligibility criteria:

• Each clinical trial has a different set of criteria for its target study population.
• You will be screened to determine eligible for that particular clinical trial.

Here is some general information you should know about the way clinical trials are carried out:

• Each clinical trial is conducted according to its Study Protocol. Therefore, each clinical trial is different.
• The main person responsible for the project is the principal investigator (PI).
• Physicians, dentists, basic research scientists, faculty members, graduate students, and postdoctoral fellows may also be involved.
• The study may include a research coordinator or a nurse who are both specially trained in research and will be there to help with scheduling issues and answer questions or address concerns.

Clinical research studies benefit society in different ways.

• Clinical trials help generate new scientific knowledge about the cause, treatment, and prevention of diseases.
• Clinical trial participants may improve their own health during a clinical trial and have access to new therapies before they are available to the public.

Clinical research studies enroll people who meet specific eligibility criteria. Each clinical trial has a particular study population.

The following groups may participate in clinical research:

• Adults
• Children
• Older adults and geriatric populations
• Healthy individuals
• Individuals with illnesses

Your eligibility may be determined by various factors, depending on the nature of the study. The factors determining whether you can participate in a particular clinical trial are called “eligibility criteria.”

Eligibility criteria are requirements that participants must fulfill to qualify for a particular clinical trial. Researchers determine these requirements based on the specific research they want to conduct. Eligibility criteria often refer to the following characteristics:

• Type of health condition
• Severity of the health condition
• Coexisting conditions
• Past or current treatments
• Diagnostic procedures
• Medical history
• Pregnancy
• Demographic information
• Other relevant considerations

If you meet the eligibility criteria at screening and sign an informed consent, you will be officially enrolled as a participant in the clinical trial.

Here are some important considerations:

• You will receive an “Informed Consent Form” containing a detailed written description of the study, any risks involved, and your rights as a participant.
• If the screening process involves any type of intervention, such as obtaining a blood sample or documenting personal health information, you will have to provide your informed consent before the screening.
• Even if you have agreed to participate in a clinical trial by signing the consent form, you can still withdraw from the study at any time without penalty if you have second thoughts or feel uncomfortable.

Our research and clinical trials are driven toward improving healthcare for all. Here are some general responsibilities as a clinical trial participant.

• Make sure your contact information is accurate.
• Attend all the scheduled appointments or inform the research staff in advance if you cannot attend an appointment.
• Arrange your own transportation during the study.
• Follow the directions of the researchers.
• Reveal your past and present medical history if it is relevant to the study.
• Discuss any questions or concerns with the researchers at any point throughout the trial.
• Inform the research staff of any adverse events you experience while enrolled in the study.
• Inform the Institutional Review Board Office if you feel your rights as a participant have been violated.

Since every clinical trial is different, you might be asked to complete additional specific requirements.

If you choose to participate in a clinical trial you will have the right to:

• Be treated with respect at all times.
• Know the risk involved with the study participation.
• Know what alternatives are available.
• Withdraw from the study without any penalty.
• Receive a sufficient amount of time to decide on participation.
• Be informed of the name, credentials, and contact information of the principal investigator.
• Be informed of the purpose of the study.
• Be informed of who will have access to your information.
• Be informed of what procedures may be performed and what drugs may be used.
• Feel comfortable asking questions during any time of the study.