Participating in a Clinical Trial or Study

Clinical research and trials offer hope for many people and a chance to help researchers find better treatments for others in the future. However, they wouldn't exist without the people who volunteer to participate. By volunteering you may help researchers:

  • Help other people who are sick
  • Find safer or better treatments
  • Find ways to improve medical care
  • Learn more about how the human body and mind work

Clinical Research Participants

Clinical trials require different types of people. Each type chooses to participate for different reasons.

  • Healthy Volunteers
    Healthy volunteers play an important role in research because they help define “normal” ranges. While they may receive no direct benefit, healthy volunteers may choose to participate in clinical research because they want to help others and contribute to advancing science.
  • Patient Volunteers
    People with a health condition or disease may take part in a research study to gain access to a new therapy; take a more active role in their health; or contribute to better understanding, diagnosing, or treating that disease or condition. While some patient volunteers may receive a direct benefit from participating, the overall goal of the clinical trial may be to understand the risks and benefits of a treatment and to scientifically prove whether it is effective.

Who Can Participate?

Researchers use a list of rules called eligibility criteria to decide who is eligible to be in the study. These criteria ensure it is safe for you to participate. They also ensure the study results are due to the treatment being studied and not other factors or chance.

“Inclusion criteria” are factors that allow someone to be included in the study. “Exclusion criteria” are factors that disqualify someone from being in a study. These factors can include:

  • Age
  • Gender
  • Type and stage of a disease
  • Previous treatment history
  • Other medical conditions
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Deciding to Volunteer

There are different ways to participate in clinical research. You may need to visit the hospital, doctor's office, or nursing home. Or you may participate in a classroom, in your own home, or through an online survey or questionnaire. Types of participation can include:

  • Completing a questionnaire about health or behaviors, or answering questions in an interview with researchers
  • Donating a tube of blood or a tissue sample
  • Taking part in a clinical trial to find out if new therapies are safe and effective
  • Helping researchers understand how the healthy body works

Understanding the Risks

Clinical research can have risks, just like routine medical care and the activities of daily living. While some of the risks are minor, other risks are more serious. Some clinical research participants may experience complications that require medical attention. It is rare for people to be seriously injured or die from complications related to clinical trial participation. When considering whether to participate in a clinical trial, it’s important to understand:

  • The possible risks of being in the study
  • The level of risk or harm
  • The chance of that risk or harm happening

Where to Find the Risks

The risks of a specific research study are described in detail in the informed consent form and will be explained to you by the study team. The study team will also explain the purpose of the study and what will happen while you are in it and will answer any questions you have.

Questions to Consider Before Volunteering to Be in a Study

Educating yourself about the study and its risks and benefits will help you determine if participation in a clinical trial is right for you. The research team should be able to answer your questions before you decide.

While every study is different, here are some general questions you will want answers to before you decide. Most of this information will also be in the informed consent document you will need to sign before you join a study. You can also download a PDF of the questions below and print it before you meet the study team.

  • What’s the condition being studied?
  • What is the main purpose of the study?
    • Why is this study being done?
    • Why is it important?
    • Why is the study needed and what important questions will it answer?
  • If this is a clinical trial, what phase is it?
  • Why do researchers believe the treatment being tested may be effective?
    • Has it been tested before?
    • What were the results of earlier studies of this treatment?
    • How likely are those results to apply to me?
  • What treatments will I receive during the study?
    • How do they compare with what I would receive if I don’t join the study?
    • What alternatives are available to me?
    • Will I know what treatment I am receiving?
      • Will my doctor know?
      • Is there a placebo in this study?
  • How could the study treatment affect my daily life?
  • What kind of tests and procedures will be done to me during this study?
    • How often?
    • Will I have to be hospitalized for any of the tests, procedures, or treatments?
  • Who can be in the study?
  • How long will the study last?
  • What will happen to my samples (blood, tissue, etc.) that you collect for the study?
  • What are the possible short- and long-term risks or side effects I might experience?
    • How do they compare with standard treatment?
  • What are the possible benefits of participation?
  • Are there reasons the study might be stopped early?
    • Are there reasons I might be removed from the study?
  • Will I be able to see my own doctor?
    • Who will be in charge of my care?
  • Will this study require extra time or travel from me?
  • Who is sponsoring the study?
  • Will I have to pay for any part of the study?
    • Will I be paid for participating?
  • What will my health insurance cover?
  • How will you protect my privacy and the confidentiality of my health and research records?
  • What happens if I become sick while participating in the study?
  • Can I choose to remain on this treatment after the study is over?
  • How are the study data and patient safety being monitored?
  • When and where will study results and information go?
  • Will you tell me about my personal results?
  • Will you tell me the overall study results when it is completed?
  • How long do I have to decide whether or not I want to participate?
Learn More About Clinical Trials at Duke
Contact the Duke Recruitment Innovation Center
studyrecruitment@duke.edu
or
919-681-5698