- Who can participate in a clinical trial?
- What should I do and ask when I meet the study physician or research coordinator?
- What is informed consent?
- What happens during my participation in the trial?
- Do I still see my primary care physician during my participation in the trial?
- What are the possible benefits and risks of participating in a clinical trial?
- How is my safety protected if I participate in a clinical trial?
The clinical trial protocol for each study specifically explains who can and cannot participate in a clinical trial. There are specific conditions or criteria that are part of the protocol that a person must meet in order to be considered eligible for participation. There are two types of criteria involved in determining whether a person is eligible to participate in a trial. Inclusion criteria are conditions or factors about a person which must be present or true in order to be eligible for the trial. Exclusion criteria are factors or conditions which if present or true disqualify a person from participation. Inclusion and exclusion criteria might pertain to factors such as your age, gender, disease or illness status, or previous treatments you may have received. Inclusion and exclusion criteria are designed to help protect the safety of those participating and to help insure that the research question being studied is able to be answered as efficiently as possible.
During any conversation you may have with the physician or research staff conducting the clinical trial or a member of their research staff, you should feel free to have a relative or friend with you to help ask questions and to hear what the researchers have to say about the research study. Listen carefully to what they have to say and review the informed consent carefully with them. Below is a list of questions which may be answered in the informed consent for the study, but you may want to make a point of asking:
- What exactly is the purpose of the study?
- Who is eligible to participate in this study?
- Why does the study physician believe the new medicine, device, or treatment may be beneficial or effective?
- How many people have been enrolled in the study nationwide or internationally?
- How many people have been enrolled in the study by the study physician?
- What tests, procedures, and medications are involved in the study?
- What are the alternatives to participating in the study?
- What are the possible benefits to participation in the study?
- What are the possible risks and discomforts involved by participating and how do they compare to the alternatives to participating?
- How might participation and the experimental treatment affect my daily life?
- How long will my participation in the study last?
- Will any of the tests or procedures involve being hospitalized?
- Which tests, procedures, or services involved in the trial will be billed to me or my insurance?
- Which tests, procedures, or services involved in the trial will not be billed to me or my insurance?
- Will I be reimbursed or paid in any way for my participation?
- How might I know if the medication or treatment is working in any way?
- Will the results of the study be made known to me at any point?
- Will I be told which treatment group I was assigned to?
- Who will be in charge of my care?
- Who should I contact or go to if I experience any unexpected effects or complications?
- Who do I notify if I decide to leave the study?
You should feel free to ask any and all questions you can think of, read the informed consent carefully, and take whatever time you feel necessary to decide whether you want to participate in the clinical trial.
Informed consent is the process by which a person is provided with full and adequate information regarding a clinical trial prior to deciding whether he/she wishes to participate in the trial. Informed consent involves explanation of the trial by the study physician or research staff member and involves an informed consent document that includes all pertinent details of the study and participation in the study. The informed consent document should include sections on:
- Background information and purpose of study
- Total number of participants
- Plan of study (schedule of tests, procedures, and medications)
- How assignment to study groups (treatment group versus control group) is determined
- Length of participation in the study
- Possible benefits
- Possible risks and discomforts
- Who can participate in the study
- Who may not participate in the study
- Alternatives to participation
- Confidentiality of data collected
- How you will be informed of new findings
- Costs to you or your insurance for participating
- Payments to you for participating
- Compensation in case of injury during your participation
- Your rights as a participant in the study
- Key contact information
You need to feel comfortable that you've had the trial adequately explained and that you understand everything discussed in the informed consent document. Finally, you should bear in mind that the informed consent is not a contract, and that you may decline to participate or withdraw from the study at any time.
While the exact processes that you will participate in vary with each trial, there are certain aspects common to all clinical trials that you should expect to encounter. The clinical research team conducting the study will include doctors and nurses and may include social workers and other health care professionals. They check your health at the beginning of the trial, give specific instructions for participating in the trial, monitor you carefully during the trial, and stay in touch after the trial is completed. Some clinical trials involve more tests and doctor visits than you might normally have for an illness or condition.
In most cases, you will continue to see your primary care physician during your participation in a trial. This is because most clinical trials involve relatively short-term care aimed at examining a specific medical condition. As such, most trials do not provide comprehensive or long-term health care.
Potential benefits of participating in a well-designed and well-executed clinical trial include:
- Receiving expert medical care at a leading medical center during the trial
- The ability to play an active role in your own health care
- Receiving new or experimental treatments prior to them being widely available
- Helping other people by contributing to the clinical research of a new medicine or treatment
Potential risks associated with participating in a clinical trial include:
- Side effects of the new medicine or treatment that may be:
- Unpleasant or uncomfortable
- Serious and long lasting
- In some instances even life-threatening
- A lack of effectiveness of the new medicine or treatment
All clinical trials follow a carefully written and reviewed study protocol, which provides in great detail, information about exactly how the investigator is to conduct the study. All clinical trials conducted in the United States must be reviewed and approved by an Institutional Review Board (IRB) prior to beginning the study. The IRB is comprised of physicians, healthcare personnel, non-scientists, and community members. The purpose of the IRB is to determine that:
- Any associated risks of participation are as low as possible
- There is an appropriate balance of benefits and risks
- An informed consent is created to allow study participants to be properly informed about the study, it's risks and possible benefits prior to beginning participation in the study.
- The research is conducted in an ethical manner
- The rights and privacy of study participants are adequately protected
Any institution conducting clinical research is required by federal regulations to have such an IRB and to have that IRB review and approve the study initially and periodically over the course of the study.