Myths and Truths About Clinical Research
MYTH: A patient can become the subject of a clinical trial without knowing they are receiving an experimental procedure or medication.
TRUTH: All patients in a clinical trial are volunteers.
Furthermore, even after giving formal signed consent to be a participant in a trial, patients are free to withdraw from the study at any time they choose.
MYTH: Patients in clinical trials are guinea pigs because no one knows what to expect from experimental treatments.
TRUTH: Most clinical trials underway at Guthrie are Phase II and Phase III studies. Earlier phase trials have already determined the basic safety of the treatment.
Physicians know what is expected from the treatment, or use of the experimental device or drug. The objective of Phase II and Phase III trials is to prove that the desired outcome is obtained over a higher number of medical cases, that is, that the treatment or drug works. In this way, what was once "experimental" medicine may become a reliable part of "everyday" medicine. All known side effects or risks of these prior studies are discussed openly with physicians and their patients.
For all patients in any clinical trial at Guthrie, their ongoing medical condition is carefully monitored, recorded, and evaluated by the entire team of medical professionals involved in their care. Any side effects noted are communicated to the patient. Because patients voluntarily take part in a clinical trial, they may decide to withdraw at any time, and so they can choose whether the potential benefit of the procedure or medication outweighs the side effects they may be experiencing. The ongoing results of a clinical trial are reviewed by immediate staff, as well as by clinical researchers and the Institutional Review Board. A trial can be suspended or stopped if there is reason to suspect that side effects are presenting risks that outweigh the benefit of the study. At all times, practicing medicine in a way that upholds the integrity of the patient’s quality of life is the most important factor in Guthrie Clinical Research.
MYTH: Doctors who practice research are more interested in experiments than patients.
TRUTH: Guthrie clinical trials are carefully regulated, not only in the areas of procedures and documentation, but also from the standpoint of ethics.
There is no monetary reward for doctors who use a research protocol to treat patients. Furthermore, the very process which integrates clinical research into medical practice is itself a safety net that ensures that only the best and most appropriate care possible is provided at Guthrie. There can be no interruption of medical care based on a patient’s interest to participate in, or a decision to withdraw from, a clinical study. At all times, the patient’s best interests are at the center of medical care at Guthrie.
MYTH: Clinical research is funded by companies which control the results.
TRUTH: Again, Guthrie clinical trials are carefully regulated, not just from the standpoint of procedures and documentation, but also from the standpoint of ethics.
Guthrie physicians determine whether certain treatments and medications are effective regardless of their potential for commercial production by an outside entity. At Guthrie, some historical clinical studies have proven certain medications are NOT effective.