With 35 years of experience as an oncologist and hematologist, Dr. MacLaughlin has also devoted much of his medical career to clinical research, an early interest sparked during his undergraduate work in biology and physiological psychology. He believes clinical studies are useful for maintaining awareness of new treatments coming along and also for offering patients access to them earlier, with hopes for better outcomes.
The bulk of Dr. MacLaughlin's research as a clinical investigator has involved cancer studies, primarily focused on lung and breast disease. He has developed clinical trials at Riverside that deal with early and advanced stages of triple-negative breast cancer, a type that does not respond to hormonal therapy. His studies have helped our physicians determine which treatments are better tolerated by these patients, leading to more uniformity of best practices.
Dr. MacLaughlin's trials have also discovered improved treatments for lung cancer by determining that continuing treatment past the point of response and providing longer periods of maintenance therapy resulted in better disease control and survival rates. Another trial measures patients' preferences regarding newer oral targeted therapy versus intravenous therapies.
Explaining that a clinical trial is an analysis of new and/or existing therapies to determine which is better or to learn more about the impact of a treatment itself, Dr. MacLaughlin says trials can be performed in almost any setting with almost any disease type, from simple to complex. The only way to scientifically prove that one treatment is better or safer than another, or has fewer or more side effects, is through a formal clinical trial that controls the other variables and evaluates patients in a specific manner. Otherwise, it is difficult to know if a positive outcome is actually the result of a superior treatment. This is the way medicine progresses in terms of quality, which leads to more successful treatment approaches, says Dr. MacLaughlin.
Before a study begins, participants are educated thoroughly, in part through a detailed informed consent document that outlines the trial, its purpose, treatments and why they were chosen, expected side effects and potential benefits. Laypeople are often involved to make sure the consent form is readable and understandable. By this point, even new, truly investigational treatments have been through preliminary testing beforehand, in which small doses are gradually increased to determine safety.
A formalized follow-up method analyzes laboratory tests or x-rays and monitors certain symptoms to determine the impact of treatment. This process, often repeated at more frequent intervals than standard practice allows, is developed by experts in the field-for example, lung cancer experts design a lung cancer study.
While it is impossible to guarantee that a clinical trial will be directly beneficial to a particular patient, at the very least it contributes to the overall understanding of a disease process that may help others in the future. But even for an individual patient, there are two big advantages. First, it is sometimes the only way to obtain access to a cutting-edge or investigational treatment not yet commercially available. This is particularly advantageous for people with tumors that are difficult to treat or when the current treatment has room for improvement.
Secondly, even in a clinical trial comparing the current standard treatment with something new, where there is a 50% chance that a patient receives the traditional therapy available outside of the study, he or she still receives state-of-the-art treatment in addition to closer monitoring and potentially better management.
In the event of side effects or adverse events, clinical trial protocols usually have specific recommendations for management. Beyond that, in the case of unusual side effects, even unrelated to the treatment, Riverside physicians have access to input from national experts who designed the trial and have even more familiarity with the therapies. All clinical trials go through multiple layers of analysis as to their scientific merit and safety before ever being offered to patients, to ensure the provision of adequate protections.
You can find Dr. MacLaughlin's publications on PubMed.
Learn more about William W. MacLaughlin, M.D.