Clinical trials of potential therapies are scientific experiments designed to answer specific questions, including the following:
- Is the experimental procedure or treatment well tolerated by patients with specific cancers?
- Does the experimental treatment have a therapeutic effect on patients' disease?
- Is the experimental treatment better than the current standard therapy or other available treatments?
Investigators undertake clinical trials because until a potential treatment is tried in humans, it cannot be known if it will be safe and effective in clinical practice. Along the way from laboratory to clinic, many novel treatments turn out to be disappointments. Substances that do one thing in a cell culture or a mouse can do something else, or nothing at all, in humans.
Oversight of Clinical Trials
Individual studies may be initiated by the National Cancer Institute and other government agencies, by medical academic centers and cancer centers, and by private pharmaceutical and biotechnology companies. Often several institutions will form cooperative groups to administer large multicenter trials and sponsor research in particular areas of cancer care. Memorial Sloan-Kettering investigators hold leadership positions in many of these cooperative groups and participate in most of them.
Every clinical trial has a principal investigator who is primarily responsible for the conduct of the trial. All institutions that receive federal support for clinical trials must also have an institutional review board (IRB) with oversight responsibility for the institution's clinical research. The IRB has authority to approve, require changes, or disapprove all the research involving human beings at the institution and oversees informed consent of patients in clinical trials. Memorial Sloan-Kettering's IRB reviews all protocols, informed consent documents, and other material related to our clinical trials and monitors each study from beginning to end.
