As we move through our day, it is likely that we unknowingly pass one of many unsung heroes of medicine. I refer to the research volunteers who participate in drug and device development clinical trials for the benefit of each and every one of us. The research volunteer who fully informed, consents to participation in clinical research is truly the bedrock upon which we assess the safety and efficacy of new drugs and devices for human populations.
Laboratory bench research and animal research, the latter conducted under strict ethical oversight, precede testing in humans. Theoretical and actual compatibility of a drug with living biological systems are confirmed prior to passage into the 4 phases of human testing. However, inevitably all drugs and devices in development must enter human trials. It is at this point that research volunteers step forward for us. Despite the tolerability of research molecules in test animals, before a drug or device is licensed for public use it must be demonstrated to be safe and efficacious in humans. For these volunteers, out of a history that has been at times dark and blighted, has emerged a multi-tiered system of regulatory and ethical oversight for their protection. Institutional Review Boards, Data Safety Monitoring Boards, the FDA, Medical Monitors, and Principal Investigators, and Clinical Research Study Coordinators are at the vanguard of protecting our precious research volunteers.
Institutional Review Boards are non-governmental agencies which oversee the informed consent process, and monitor the progress of the clinical trial. Data Safety Monitoring Boards monitor the safety of the study drugs or devices throughout the trial and are empowered to stop the study abruptly, if safety concerns emerge. The FDA ensures that clinical trials are conducted in compliance with federal law and GCP, or Good Clinical Practice. Upon filing the 1572, the FDA grants the Investigator the authority to conduct research on human volunteers. This brings me to a most important point, which is that the Investigator, the licensed physician actually conducting the trial is ultimately responsible for the safety of the volunteers he enrolls and for insuring that the trial is conducted in compliance with GCP.
At York Clinical Research, LLC, I, the Principal Investigator, and the entire research staff are committed to the safety of our research volunteers. You will not find research volunteers in the limelight but our collective indebtedness to them cannot be overstated. Margaret Mead stated “Never doubt that a small group of committed people can change the world. Indeed, it is the only thing that ever has.” At York Clinical Research, LLC we value and celebrate our research volunteers…true heroes of medical science. York Clinical Research, LLC, Advancing and Improving Healthcare through Innovation and Discovery.