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The participant’s safety is paramount and beyond the public and scientific interests of the trial. All participants are under continuous care of qualified clinical teams during the trial period. The Clinical Trial follows a protocol, which includes a trial plan that describes what researchers will do in the trial. As the Clinical Trial progresses, all results are reported to scientific meetings, medical journals, and to Independent Review Boards (IRB) and the FDA. The names of the participants will remain secret and will not be mentioned in any reports.

Clinical trials are usually conducted in three phases (I, II and III). Only a small number of volunteers, usually called 'healthy volunteers' participate in phase I trials, while the later phases involve a larger number of patient volunteers. At ICON, we focus on what’s known as 'late phase' clinical trials. These studies look into the effects the treatments being researched have on the conditions they were designed to treat, and all will have undergone some earlier phase testing.

A clinical trial can only be offered to our trial patients once it has been approved in the U.S. by the FDA, as well as an Independent Review Board (IRB) who look to ensure that the rights and wellbeing of all trial patients are not being compromised. Many trials, particularly phase III studies are conducted worldwide with a large number of patients participating in them. They will have to be approved by the regulatory agencies in their countries (e.g. the FDA in the United States) and the results collected from all trial participants globally are monitored closely during the trial process. Our clinical trials are also rigorously monitored by both internal and external audits along with regulatory inspections throughout.

Volunteers in a clinical trial participate in the development of medical therapies that may offer better treatments for life threatening and chronic diseases. The possible benefits for volunteers include:

When a person decides to participate in a Clinical Trial, they must sign an “Informed Consent” document containing information about the Clinical Trial. The physician then provides information about possible risks and benefits and what is required by the participant during the Clinical Trial. The participant then decides whether to or not to sign the Informed Consent. It is very important to emphasize, that the Informed Consent is not a contract and that the participant may withdraw from the trial at any time, without giving any reason.

A third-party, unbiased review board (IRB) must approve all payments to patients. It is usual for all reasonable travel expenses to be paid. Some clinical trials make patient inconvenience payments to volunteers for their participation in trials and this will be summarized in the Participant Information Sheet for each trial. All trial assessments and the investigational treatment will be provided to you at no cost.

If you participate in a clinical trial, your data will be coded and collected on a paper record, and it will be kept confidential. To make sure the information collected in the trial is accurate, it will need to be checked by researchers and authorized persons working on behalf of the pharmaceutical company and for government health departments. You are asked to give permission for these authorized people to see your medical records, who will keep the information confidential.

You can be given a copy of the trial results once they are publicly available, if requested. Any report that is published about the trial will not identify you or any other patient taking part.