Things To Know Before Participating In A CLINICAL TRIAL

Deciding to take part in a clinical trial can be hard, but it’s your choice to make. A lot has changed over the past few decades, and many people want to know as much as possible about all of their treatment options before they make up their minds. People should learn as much as possible about the clinical trials that interest them. They should also feel comfortable discussing their questions and concerns with members of the health care team. Prospective participants should understand what happens during the trial, the type of health care they will receive.

Some of the basic Questions that one should answer themselves before participating

•      Why do I want to take part in a clinical trial?
•      What are my goals and expectations if I decide to take part?
•      How realistic is the trial?
•      The chances of benefit versus risk?
•      What is being studied during the trial?
•      What are the possible interventions that I might receive during the trial?
•      What tests and procedures are involved?
•      Will hospitalization be required?
•      How could the study treatment affect my daily life?
•      How long will the study last?
•      Who will pay for my participation?
•      Will I be reimbursed for other expenses?
•      What type of long-term follow-up care is part of this trial?
•      Will results of the study be provided to me?
•      What are my options if I am injured during the study?
•      Is there patient confidentiality in the trial?

Potential Benefits

Participating in well-designed and well-executed clinical trials is one approach for eligible patients/volunteers to:

• Get actively involved in their health care.
• Gain access to potentially new research treatments
• Have access to expert medical care for the condition being studied, since investigators are often specialists in the disease area being studied.
• Help others by contributing to medical research.

Possible Risks

There are generally known and unknown risks associated with clinical trials, such as:

• There may be unpleasant, serious, or even life-threatening side effects resulting from the treatment.
• The treatment may not be effective for the participant.
• The protocol may require more of the participant's time and attention than a standard treatment. (Participants may need to visit the study site on a regular basis, be subjected to additional tests, get more treatments than are normally necessary, stay in the hospital and/or follow complex dosage requirements)

Safeguards

Several levels of safeguards are in place to help protect the people who take part in clinical trials. There are still risks involved with any study, but these safeguards try to reduce the risk as much as possible.

Three basic principles, as outlined in the Belmont Report from the late 1970s, provide the basis for research involving humans:

• Respect for persons: Recognizing that all people should be respected and have the right to choose what treatments they receive
• Beneficence: Protecting people from harm by maximizing benefits and minimizing risks
• Justice: Trying to ensure that all people share the benefits and burdens of research equally

Having an idea of what you can expect from taking part in a study can help relieve some of your concerns and make things go more smoothly. The first thing you will need to do is give your informed consent to take part in the study.

Informed Consent

The people running the study are required to get your written, informed consent before you take part in any way (often even before you have any needed tests to see if you are eligible for the study). In the informed consent process, the researchers (doctors or nurses) will explain the details of the study to you and answer your questions and concerns.

Before you sign the consent form, ask questions. Be sure someone from the research team goes over the form with you in detail. Consent forms are not all easy to understand, and there may be words or ideas that seem confusing. You may want to bring someone along with you to the meeting to help make sure all your concerns are addressed.

Taking Part in Study

Once you’ve signed the consent form, you will be ready to take part in the study. You’ll probably need to have blood tests or imaging tests done before you start treatment (if you haven’t had them recently). A full medical history and physical exam are also usually done. The results are needed before you start the actual study to be sure that you meet the eligibility criteria and to help ensure your safety.

How to leave the study early

You may quit taking part in the study for any number of reasons:

• You completed treatment on the study
• The treatment does not appear to be working for you
• You have serious side effects while in the study
• The study itself is stopped early because the treatment either has proven to work, has proven to not work as well as the standard treatment, or it’s been found to be too harmful
• You decided to leave the study

There are different groups that can provide guidance for people before participating in clinical trial

• American Cancer Society
• Emergency Care Research Institute (ECRI)
• National Institute of Mental Health
• American Association of Health Plans
• Food and Drug Administration
• National Multiple Sclerosis Society
• National Institute of Health

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Written by
Harisha Kothapalli
harisha.kothapalli@clinzen.com