The ethical and legal codes ruling medical practice also apply to clinical trials. In addition, most research is federally funded or regulated (all COG trials are), with rules to protect patients. COG also has review boards that meet at prearranged dates for the duration of a clinical trial to ensure that the risks of all parts of the trial are acceptable relative to the benefits.
Side effects are reported by the treating institution. If concerns are raised, the study may be temporarily halted while an independent Data Safety and Monitoring Board (DSMB) and the study committee review the situation. If one arm of the trial is causing unexpected or unacceptable side effects, that portion is stopped, and the children enrolled are given the better treatment. If one of the arms appears to be less effective than the standard, it will be terminated. Conversely, if one arm is better than the standard, the trial will also be terminated.
When Brian first entered the CCG-1922 protocol, there were four arms. One was to see which had the best response in treatments between prednisone versus decadron and 6MP versus 6TG. After Brian completed this protocol, in December 1996, we were told that the patients that were on 6MP and prednisone were to be switched to 6MP and decadron. There seemed to be a better outcome.
The results of the CCG-1922 study are not complete. But we were told in the beginning of the protocol that if one arm was doing better than the other arm, the patients would be switched to the better arm.
All institutions that conduct clinical trials also have an Institutional Review Board (IRB) or an ethics committee that reviews and approves all research taking place there. The purpose of such boards and committees—made up of scientists, doctors, nurses, and citizens from the community—is to protect patients. Before a child is enrolled on a COG trial, the trial must be reviewed and approved by the NCI and COG. In addition, the IRB at the hospital where the child is being treated must also approve the trial.
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