If you are considering participating in a clinical trial, know that your safety is a priority at every stage. Ask your doctor questions regarding the study, and what the exact benefits and risks associated for you may be. If you have specific health condition(s), your doctor will assess these benefits and risks alongside your current healthcare and treatment plan.

Potential Benefits:

• You may receive a new treatment for a condition/disease before it is available to the public
• It enables you to play a more active role in your health care
• Improved understanding of current health condition, including potential information for support groups and other resources
• Increased medical care, with frequent health check-ups throughout study
• You may receive diagnostic tests such as ECGs, lab work, and X-rays
• Immediate access to doctors and specialists on a regular basis
• Access to new medications, devices, or procedures before they are widely available
• Potential compensation for study participation
• Increasing the possibility for others to receive better health treatment(s) in the future, through your participation

NOTE: Insurance is not needed when joining a study! Clinical trials are federally or privately funded to ensure that participation is almost free for each volunteer.

Potential Risks:

•  Potential side effects of new treatment(s)
•  Treatment may not work as intended or may not be as effective as those currently available
•  Participation expectations vary across each clinical trial, with some being more time consuming then others (e.g. multiple full day and/or overnight visits)

Clinical trials are usually conducted in four phases (I, II, III, & IV). If a new treatment or medical device is successful in one phase, it continues on to the next. In Phase I trials, a small number of healthy volunteers participate to ensure the medication is safe. From here, studies progress to include specific health conditions/diseases in larger populations across longer-term trials, and further examines how the studied treatment/device compares to the current treatment (Phase II & III) – these phases are needed before the FDA can approve a new treatment for the public. Once approved by the FDA, Phase IV trials begin, further assessing the new treatment’s short and long-term safety and efficacy.

Studies are designed to ensure that the wellbeing of each participant is met, and are closely monitored throughout. Every trial is made up of different medical exams and requirements to assess the health of participants. Most studies involve multiple visits to check-in with the study coordinator and doctor. These visits allow participants to report any issues, address questions or concerns, as well as perform any other health exams as required (blood draws, ECG, lung test, etc.).

During the screening visit (first meeting), participants are given an overview of the study and are asked questions to see if they meet the requirements outlined in the study Protocol (study rules/guide). Some of the most common information needed to assess eligibility is medical history, as well as lab work and a full routine physical exam. You will typically have three different types of visits during the course of a clinical trial:

• A screening visit: The informed consent document is reviewed with you, and a complete medical history is taken.
• A baseline visit: This is the first step in the trial where you will receive your study medication and go through a dosing review with your doctor and/or research coordinator.
• Routine study visits: Periodic visits throughout the study that are done to track an individual’s progress during the trial. The study team may take bloodwork, administer the study medication, and perform a regular check-up during these visits.

Reimbursement may often be provided for travel, accommodation, and other specific expenses that may arise. Additionally, financial stipends may also be provided per visit, or at trial completion depending on the type of study you are in.

Clinical trial data is highly confidential. Before a study is completed, only select research staff, sponsors, review boards, and regulatory individuals are allowed to access trial data. Sharing patient data before a trial ends can compromise the validity of the study in its entirety and jeopardize patient confidentiality and privacy. The trial doctor will let you know what information they can and cannot share with you before the trial has officially ended. Once a study is completed and results are shared, you may request your records from the study site.

Researchers will analyze all the information and data that has been collected from participants throughout the study. Information collected from each volunteer will be compared with data from other trial participants. All information collected is kept private and confidential, with data reports, sharing, and storage kept secured and in accordance with Good Clinical Practices. This data is then analyzed by doctors and specialists, with findings reported to scientific groups and medical journals. These findings are also shared with experts and various government agencies who are responsible for the approval of new medications and devices.

Whatever you are unsure of! When participating in a clinical trial, you should feel comfortable  with your decision to participate. Let your doctor and research coordinator know about any questions or concerns you may have to ensure you feel confident in your decision to participate.  Here are some questions to keep in mind during your screening visit! The majority of these may already be answered in the informed consent form and addressed by your research team:

• What is the purpose of this study?
• Why do researchers believe the new treatment may be effective?
• Has there been other studies investigating this same treatment?
• What kinds of diagnostic exams are involved?
• What are the possible risks, side effects, and benefits of the study?
• How might this trial impact my daily life?
• How long will the trial last?
• Will I be reimbursed for other expenses?
• What type of long-term follow up care is included in this study?
• How will I know that the treatment is working?
• Will results of the trials be provided to me?
• Who will be in charge of my care?