Who is Involved in Clinical Trials?
Clinical trials are only possible with the help of every member of a team of people with a variety of skills and experience. Most of all, it is participant’s involvement that helps researchers to ultimately uncover better ways to treat, prevent and understand human disease.
Trial Participants
Individuals who agree to take part in the clinical trial. They can be healthy subjects or patients with the disease (or expected to develop the disease) that the new drug is intended to treat or prevent.
Trial Investigators
Doctors responsible for running a clinical trial. The principal investigator is the person who is responsible for the scientific and technical direction of the entire clinical study.
Trial Coordinators
Individuals who assist study investigators in carrying out the trial. They are often the main point of contact for the trial participants.
Trial Sponsors
Parties responsible for initiating, organizing and/or financing a clinical trial. Clinical trials can be sponsored by pharmaceutical companies, academic medical centers, voluntary groups, and other organizations. Doctors can also sponsor clinical research.
A Sponsor is legally responsible to ensure that the trial is conducted according to the protocol, current and local regulations and comply with Good Clinical Practice (GCP) guidelines.
Trial Sites/Centers
Places where a clinical trial is conducted. They can be a trial clinic, health clinic, hospital, or doctor's office.
Patient Advocacy Groups
Non-profit organizations that represent and support patients with a specific disease, their families and/or caregivers. They help educate patients about the importance of taking part in clinical trials and help them find trials to participate in. They are involved in the review of trial design and protocol and in trial documentation for lay people.
Ethics Review Boards
Independent committees of doctors, data experts, patients’ advocates, and lay people. They review a clinical trial’s design and any information provided to participants to ensure that the clinical trial is ethical, and that the participants’ rights, safety, and well-being are protected.
Data and Safety Monitoring Boards (DSMBs)
Group of external, independent experts who monitor any potential safety concerns that may occur during a clinical trial.
Health Authorities
Government entities responsible for approving drugs and clinical studies.