Clinical trials are designed to test treatments under very specific scientific and ethical guidelines. Clinical trials use written protocols to define the purpose, design and conduct of a specific clinical trial. All of the research centers participating in a particular study use the same research protocol. The 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.
In order 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 (IRB). 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. Committee members serving on Institutional Review Boards address the following questions in reviewing protocols:
- Does this protocol have scientific value?
- Does the protocol have scientific validity?
- Does the study have a valid scientific design and yet pose an inappropriate risk for subjects?
- Are risks to subjects minimized?
- Are the risks to subjects reasonable in relation to anticipated benefits, if any, to subjects and the importance of the knowledge that may reasonably be expected to result?
- Is the selection of subjects equitable?
- Are additional safeguards in place for subjects likely to be vulnerable to coercion or undue influence?
- Will informed consent be obtained from research subjects or their legally authorized representatives?
- Is there adequate provision for monitoring the data collected to ensure the safety of subjects?
- Are there adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data?
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.
Clinical trials evaluating cancer treatments or strategies may be offered in large university hospitals, local community hospitals and/or physician practices. The location where a clinical trial is conducted depends on the specific resources required to conduct the trial, the number of patients needed for enrollment in the trial to answer the question and the individual or institution’s interest in performing clinical trials in general.