Clinical Trials at Duke University Medical Center
New treatments, medicines and medical devices are crucial to improving our quality of life, but how do doctors know which medicines work and which do not?
To learn how effective these treatments are in people, doctors and scientists must ask people to take the medicine or try the new treatment and then the researchers evaluate how well it worked. The method to evaluate new medicines and treatments is called clinical research.
Over the years, scientists have developed a standard progression of research, called clinical trials, that minimizes risks to research participants while allowing doctors to ask and answer questions about a particular drug's effectiveness.
Clinical trials are crucial for making sure that new medicines and treatments are safe. This process is required by the U.S. Food and Drug Administration (FDA) before any new drug or device can be made widely available. Thousands of clinical trials are currently under way at university medical centers, hospitals and clinics throughout the world.
Clinical trials follow strict guidelines regarding who can participate in the study and how the study will proceed. Researchers categorize patient-centered clinical trials into three types, each of which has a different purpose.
Phase I trials evaluate how a new drug should be administered and in what dosage. These early, preliminary trials enroll only a small number of patient volunteers. Phase II trials test how well the new drug or device works and provide more information about safety and benefits. These studies enroll a slightly larger number of patients. Phase III trials compare new drugs to standard medications that are already on the market or to standard practices of treatment when no comparable drug is available. These trials typically enroll larger number of patients and may take place simultaneously at multiple medical centers.
People who participate in clinical trials contribute to finding better ways to prevent, detect or treat disease. But because clinical trials are by definition experimental, doctors who plan and carry them out must adhere to strict guidelines to ensure minimal risk to all participants. The federal government issues regulations designed to protect people who participate in clinical trials. It requires that each institution conducting clinical trials form an institutional review board (IRB) to oversee clinical trials at their institution. The IRB is responsible for ensuring that clinical trials at its site are conducted with the highest ethical standards and most rigorous scientific criteria.
The IRB at Duke University Medical Center is composed of 25 doctors, research scientists and members of the public who approve the protocol for each new proposed clinical trial. IRB members serve as voluntary neutral reviewers who are knowledgeable about federal regulations and standard research practices. They must ensure that the trial is conducted so that no one who participates is likely to be harmed.