How they’re conducted
Clinical trials are designed to test treatments under very specific scientific and ethical guidelines. All the research centers participating in a particular study use the same research protocol. This protocol is written by the sponsor of the study and explains what the trial will do, how it will be conducted, where it will be conducted, who may participate, and how and when the participants will be evaluated.
Sponsors of clinical trials include, but are not limited to, the National Cancer Institute, groups or networks of physicians, individuals within a single cancer institution and manufacturers of biopharmaceutical products. To protect patients participating in clinical trials, the sponsor reviews the protocol for safety and appropriateness, and then the protocol must undergo a second neutral review by an institutional review board. The institutional review board is responsible for overseeing any clinical trials that are performed in the specific healthcare institution where the clinical trial is offered/conducted. An institutional review board includes physicians, healthcare providers and individuals not involved in healthcare, including the clergy or ordinary citizens/consumers. Institutional review board members do not have any personal interest in the results of the trial and, therefore, can ensure that the study is conducted fairly and safely.
The institutional review board also reviews all informed consent documents to make sure that they provide clear and complete information for those evaluating the merits of enrolling in a specific clinical trial.