A Point of View by Eric Rubin, M.D., medical oncologist and vice president, Global Clinical Oncology, Merck Research Laboratories
Few innovations have helped as many as the advent of the modern clinical trial, especially in cancer research. Without these important studies, doctors, regulators, patients and caregivers would not be able to determine what kinds of medicines may help patients, or the potential risks.
While the idea that we can carefully evaluate new medicines is taken for granted today, the clinical trial as it is understood today dates back only to the 1940s. Prior to that time, hucksters could – and did – push useless or harmless “cures” on anyone. It's no coincidence that the great leaps forward in medicine, such as antibiotics, are closely linked with the adoption of clinical trials as the gold standard for understanding a medicine’s effects.
The basic foundations of the randomized, blinded clinical trial – comparing different groups of otherwise-similar patients and ensuring that neither doctor nor patient is aware of who receives what treatment – have proven their value. But our recent work at Merck is focused on ensuring that the clinical trials system advances and works more effectively. Quicker, smarter ways of conducting clinical trials means that we can answer scientific questions more quickly and more confidently, allowing more patients access to medicines that may potentially help them.
In some cases, we have worked closely with regulators to modify ongoing trials to enroll more patients and gather more data. New FDA rules around “breakthrough” products have allowed more collaboration with the FDA, and this kind of collaboration has helped Merck and others in the pharmaceutical industry to quickly gather the data needed to demonstrate the potential benefit of new treatment options.
Our immuno-oncology research program has been one area where we’ve been able to use these new tools. We have had the opportunity–when the early trials show promise–to expand studies to gather additional high-quality data, helping advance the potential for bringing medicines to cancer patients.
The design of Merck's oncology trials, too, is becoming more innovative. We have made important strides in developing new trial designs that allow us to evaluate multiple types of cancers in one study. This, in turn, makes it more likely that we can identify potential new medicines in a more efficient manner. The years to come are likely to see more such trials helping us to better answer questions on the best way to treat cancer.
But clinical trials can only advance cancer research if patients volunteer to participate. Merck is committed to helping educate patients, doctors and caregivers about oncology clinical trials. For more on our approach on clinical trials and ongoing clinical trials, please visit Merck Clinical Trials.