What is a clinical trial?

A clinical trial is a research study in human volunteers intended to answer health questions. They are conducted to develop new medications or treatments that can improve your health. After medication or treatment is found to be safe and effective, it may be approved by the FDA and then, it will be available for the general population.

Why should I sign up for a Clinical Trial?

Clinical trials are conducted to improve existing medications or develop new treatments to cure diseases. By volunteering for a clinical trial, you will take an active role and help gather data for future treatments that someday may benefit you, a loved one, and the community at large. You will receive medical attention from a physician, access possible investigational medications/treatments before they are widely available, and receive compensation for your time and travel.

How long does a clinical trial last?

Every study is different and so is the length of participation. Some trials can last only a day and others may last years. This information is provided on the Informed consent and should be discussed when deciding to participate in the clinical study.

What is Informed Consent?

An informed consent is a written document explaining the key facts of a clinical trial. This document is available to potential participants in their preferred language at the first site visit. It will include specifics such as the trials indication, purpose, duration, mandated procedures, and contacts. You will be given ample time to read and review this document. A staff member and study physician will review the consent with you and ensure all questions and are answered. You can then decide if you wish to participate in the trial and sign the form. The staff member and physician will sign confirming they explained the content to you and a finalized copy is provided.

Are there specific protocols and or procedures in participating in a Clinical Trial?

Every clinical trial follows a specific written protocol.  This explains how the trial will be conducted; it describes the goal of the study, how many volunteers are required, the various tests performed, the number of study visits, and what information the physician and the staff gather from the study volunteers. Once the trial is complete for all the volunteers, the information is put into a report and sent to the Food and Drug Administration (FDA) in the USA or Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK.  These agencies review the data and results. They then decide if the investigational product should be approved to treat the general public.

What can I expect during the Trial?

On your first visit to the site for a specific trial, the study coordinator and physician will go over a document called informed consent. They will provide ample time for you to read and review the document. They will explain the study and answer any questions you may have. It is important you determine if you can make the required study visits, take the investigational product as directed, and follow all other study instructions. If you are still interested, you will then sign the study consent and the coordinator and physician will sign as well. A copy of the completed consent will be given to you.  All visit tests and procedures required by the trial will be performed once the informed consent process is finalized.  Compensation for your time and travel may be available and remitted at this time. You will then be given an appointment for your upcoming visits to comply with the protocol and evaluate your health and progress in the study.

What are the different phases of a Clinical Trial?

Clinical trials are conducted in phases. Each phase is conducted for various purposes and help scientists answer different questions:

• In Phase I trials, a new drug or treatment is tested for the first time to evaluate its safety. It helps to determine a safe dosage range and identify side effects in a small group of people (under 100).
• Phase II trials are conducted to evaluate its effectiveness and to further evaluate its safety and dosage for people who suffer from a specific condition. This phase is conducted on a larger group of people (In the hundreds).
• Phase III trials are designed to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely. This phase is conducted on very large groups of people (In the thousands).
• Phase IV trials are post-marketing studies that delineate additional information including the drug’s risks, benefits, and optimal use.

How is my safety monitored?

All clinical trials in the US are federally regulated by the FDA with built-in safeguards to protect the participants. Additionally, the trials are reviewed and approved by an Institutional Review Board (IRB), Ethics Committee, and sometimes other local groups. Their main concern is the safety of the volunteers. Some protocols also have a further independent safety monitoring committee.  This committee reviews information at regular intervals during the trial to seek potential safety issues.  Lastly, your study physician and the staff will assess your health at each study visit