1. What is a clinical trial?
A clinical trial is a scientific process that investigates the safety and efficacy of a medication.
2. How is a clinical trial structured?
A clinical trial’s organization varies from study to study. However, the two most common forms are 1) open-label and 2) double-blind studies.
- Open-label studies are structured so that the treating psychiatrist and the participant both know what treatment the participant is receiving.
- Double-blind studies are structured so that neither the treating psychiatrist nor the participant knows what treatment the participant is receiving—whether it’s the investigational treatment or the placebo (a pill with no biochemical effects).
In addition to these, however, there are other formats, some of which may even have three or more groups. In order to find out exactly how your study is structured, please ask your study coordinator.
3. Who can participate?
In order to participate in a clinical trial, you must pass through two sets of criteria.
- The first set is called the “Inclusion Criteria.” These are characteristics the prospective participant must possess in order to partake in the study. Examples include requiring a participant to 1) be diagnosed with a specific disorder and/or 2) belong to a specific age-range.
- The second set is called the “Exclusion Criteria.” These are characteristics that disqualify a prospective participant from partaking in the study. For example, the exclusion criteria would prevent a patient from participating if he/she is: 1) currently taking an excluding medication, and/or 2) has an excluding medical condition.
4. I’d Like to participate but I can’t travel to your site. Do you provide transportation?
Of course! Transportation can be arranged for prospective and enrolled participants.
5. What are the risks and benefits of volunteering in a clinical trial?
- Gain access to investigational treatments before they are made available to the general public.
- Obtain free medical care while being enrolled in a study.
- Help others by contributing to the process of discovering better treatments.
- Receive monetary compensation for your time and travel.
- Side-effects may arise from the investigational treatment.
- The investigational treatment may not be effective.
- The protocol may require additional lab tests, site visits, treatment changes, etc., that require more time and participation.
6. What is the ‘Informed Consent’ process?
Before a participant is enrolled in a clinical trial, an NBR employee walks him/her through the ‘Informed Consent’ process, which outlines the participant’s rights and educates him/her about the study.
It begins with a verbal conversation. The psychiatrist speaks with the prospective participant about the study’s specifics, using simple words to explain its purpose, potential risks and benefits, the expected procedures, visits, and so on. It is here where you can—and are encouraged to—ask any questions you may have. If there is something you did not understand, ask the psychiatrist to explain it differently. Below are some questions worth asking:
- What is the purpose of the study?
- What are the potential benefits and risks?
- What kind of tests will be performed?
- Will I be able to take my regular medication during the study?
- Who else will have access to my private information?
Once you have been informed of the study’s details, you will be asked to provide written consent to participate in the clinical trial. Do so only after you’ve asked all of your questions, and you understand the study and the ways in which it can affect you. Your signature, however, does not conclude the conversation. In fact, NBR urges you to voice any questions or concerns you may have throughout the entire clinical trial process.
7. What are my rights as a participant?
It is important that you are familiar with your rights as a participant. You can exercise them at any time during the study. Below are some facts you should know:
- You reserve the right to discontinue your participation from the study at any time.
- You reserve the right to be informed of all treatment options available to you other than the investigational treatment.
- You reserve the right to receive a signed and dated copy of the Informed Consent Form.
- You reserve the right to be compensated for your time.