Volunteering for a Clinical Trial

Source: The Mayo Clinic

A clinical trial is a research process to find new and better ways to understand, detect, control and treat health conditions. The scientific method is used to find answers to difficult health-related questions.

Volunteers are an integral part of the research process. People with a particular disease as well as healthy people can play a role in contributing to medical advances. Without volunteers, clinical studies simply would not be possible.

People volunteer for clinical studies for many reasons. They may have a:

  • Desire to improve medical care for future generations
  • Connection to a certain disease or illness, whether through personal experience or through friends or family
  • Personal interest in science

Participating is a Choice

Volunteering for a clinical study is a personal choice. You have no obligation to do so, and participation is not right for everyone. After enrolling in a study, you may leave at any time for any reason.

Clinical Studies May Differ from Standard Medical Care

A health care provider diagnoses and treats existing illnesses or conditions based on current clinical practice guidelines and available, approved treatments.

But researchers are constantly looking for new and better ways to prevent and treat disease. In their laboratories, they explore ideas and test hypotheses through discovery science. Some of these ideas move into formal clinical trials.

During clinical studies, researchers formally and scientifically gather new knowledge and possibly translate these findings into improved patient care.

Types of Clinical Research
There are many types of clinical research:

  • Prevention studies look at ways to stop diseases from occurring or from recurring after successful treatment.
  • Screening studies compare detection methods for common conditions.
  • Diagnostic studies test methods for early identification of disease in those with symptoms.
  • Treatment studies test new combinations of drugs and new approaches to surgery, radiation therapy and complementary medicine.
  • The role of inheritance or genetic studies may be independent or part of other research.
  • Quality of life studies explore ways to manage symptoms of chronic illness or side effects of treatment.
  • Medical records studies review information from large groups of people.

Consent Process
Participants sign a consent form to ensure that they understand key facts about a study. Such facts include that participation is voluntary and they may withdraw at any time. The consent form is an informational document, not a contract.

Study Design
During the consent process, you may hear different phrases related to study design. Randomized means you will be assigned to a group by chance, much like a flip of a coin. In a single-blinded study, participants do not know which treatment they are receiving. In a double-blinded study, neither the participant nor the research team knows which treatment is being administered.

Some studies use an inactive substance called a placebo.

Multisite studies allow individuals from many different locations or health care centers to participate.

Benefits
When considering participation in a research study, carefully look at the benefits and risks. Benefits may include earlier access to new clinical approaches and regular attention from a research team. Research participation often helps others in the future.

Risks/Inconveniences
Risks may include side effects. The research treatment may be no better than the standard treatment. More visits, if required in the study, may be inconvenient.

Weigh Your Risks and Benefits
Consider your situation as you weigh the risks and benefits of participation prior to enrolling and during the study. You may stop participation in the study at any time.

Ask Questions
Stay informed while participating in research:

  • Write down questions you want answered.
  • If you do not understand, say so.
  • If you have concerns, speak up.

Other Resources
The Center for Information and Study on Clinical Research Participation (CISCRP) is a first-of-its-kind nonprofit organization dedicated to educating and informing the public, patients, medical/research communities, the media, and policymakers about clinical research and the role each party plays in the process.

  • www.ciscrp.org

5 thoughts on “Volunteering for a Clinical Trial

  1. I am also interested in participation. I reached out and completed a pre-study questionnaire for the Essential 3 study. I was notified via email that I had met the criteria for participation based on the results of the preliminary screen, and that someone would be contacting me. I have not received any contact and cannot find a way to reach out to the investigators. It’s been about three weeks. I’m wondering if the area I live in is too remote

      1. Our contact at Praxis has notified the clinical trial team about your concerns. Hopefully, someone will get back to you very soon.

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