Terminology Used in Clinical Trials versus Standard of Care
By Shannon Walsh, FACT Accreditation Coordinator
We have all used similar but distinct words interchangeably at times. It is easy to do and often times does not seem to matter. However, words and the message they deliver (whether intended or not) can be critical, especially in the area of clinical research.
With the new developments in immune effector cellular therapy and products recently approved by the FDA, such as Kymriah and Yescarta, it is even easier for the distinction between therapy and research to be blurred. These advances have been the focus of a lot of media attention, and laypeople may extrapolate the compelling human interest stories to any type of similar cellular therapy. Furthermore, some programs will be administering these commercial, licensed products to patients alongside research products. For other products still under research and not yet approved, staff must be aware of distinctions that must be clear to the prospective study subject.
In the United States, the Food and Drug Administration, Department of Health and Human Services, and the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, among others, have provided regulations and guidelines to ensure the protection of human subjects in research. Part of this protection involves the careful and intentional use of words when advertising for clinical trials, communicating with prospective study subjects, obtaining informed consent, and continues throughout the subject’s participation in a trial.
Words such as “treatment”, “patient”, and “cure”, when used in relation to participation in a clinical trial, can potentially blur the lines between treatment of a patient with an approved drug and enrolling a subject in a clinical research study for the evaluation of safety and/or efficacy of a test article under investigation.
For individuals to be fully informed of research under which they are agreeing to participate, they must know that it is research and that the product is not yet an approved drug for the indication being evaluated. While it is possible that the test article may help or cure the disease, it is also possible that it may not improve the individual’s condition, may cause serious adverse reactions, or may even result in death.
Federal regulations provide additional safeguards for vulnerable populations, such as pregnant women, children, prisoners, mentally disabled, economically disadvantaged, and others. Vulnerable populations may also include the terminally ill given the gravity of their illness. There is a balance between increasing access to research trials for vulnerable populations and protecting these individuals from coercion or undue influence. Considering the relationship between a trusted physician and patient, and the hope for a cure of their illness, there is a fine line in clinical research for using accurate and intentional words to ensure full understanding, autonomy, and informed consent.