Understanding Clinical Trial Studies Frequently Asked Questions

Choosing to participate in a clinical trial is an important personal decision and one that we do not take lightly. The following frequently asked questions provide general information about clinical trials. Please contact us for more detail information or questions about specific trials. Learn more about our clinical trial studies. 

Clinical trials are essential to discover new treatments for diseases, as well as new ways to detect, diagnose and reduce the chance of developing a disease. They test whether particular treatments are safe and how well they work and open the door to improve the health and quality of life for patients. 

Clinical Trial Studies create a greater understanding of new treatments before being approved or recommended for routine use. 

When deciding to participate in a clinical study, participants are helping researchers find better treatments for others in the future. Also, participants have the possibility to receive the newest treatment and additional care that otherwise they would not have access to.

Each study has a protocol with guidelines for who can or cannot participate in the study. These guidelines, or eligibility criteria, describe characteristics that must be shared by all participants. The criteria differ from study to study. They may include age, gender, medical history, and current health status. Please contact us if you are not too sure if you qualify for a study.

Informed consent is the process of learning key facts about a clinical trial before deciding whether or not to participate. Details include study design, purpose of the study, duration, required procedures, and key contacts. You will meet with a clinical study coordinator to review the informed consent document and answer any questions.

Benefits

• Gain access to new medicines and treatments not otherwise available at no cost
• Obtain close monitoring, advice, care, and support by a research team of doctors and other health care professionals who understand your disease or condition
• Contribute to the development of future life-saving or life-enhancing treatments

Risks

• The clinical trial may require more time than a typical medical treatment such as added visits to the clinical trial site
• Participants might not receive the trial medicine and as a result the condition might not improved
• There may be unpleasant, serious or life threatening side effects to experimental treatments.

Participation in a clinical trial study is voluntarily and you should discuss any questions or concerns with the Clinical Trial Coordinator or the Principal Investigator.

Participants should know as much as possible about the clinical trial and feel comfortable asking questions about it, the care expected while in a trial, and the cost of the trial. The following questions might be helpful for the participant to discuss with the clinical trial team. Some of the answers to these questions are found in the informed consent document.

•  What is the purpose of the study?
•  Who is going to be in the study?
•  Why do researchers believe the experimental treatment being tested may be effective? Has it been tested before?
•  What kinds of tests and experimental treatments are involved?
•  How do the possible risks, side effects, and benefits in the study compare with my current treatment?
•  How might this trial affect my daily life?
•  How long will the trial last?
•  Will hospitalization be required?
•  Who will pay for the experimental treatment?
•  Will I be reimbursed for other expenses?
•  What type of long-term follow up care is part of this study?
•  How will I know that the experimental treatment is working? Will results of the trials be provided to me?
•  Who will be in charge of my care?

Yes. Participants can withdraw from the study at any time. Your regular medical care will not be affected. You can stop participating without giving reason and without penalty or loss of benefits. 

Participants need to commit to a number of visits to the clinic or via telemedicine during the study. Some studies require to wear  devices, complete questionnaires, use e-dairies, perform regular lab procedures, among other things. Commitment varies depending on the study.  It is important to be reliable as the accuracy of the findings depends of the commitment of its participants.  

If you have any further questions, please contact us and we will be more than happy to answer any questions.