One of the key features of research is that it contributes to or develops generalizable (scholarly) knowledge. Any activities falling under this definition may be classified as research–regardless of what they may be labelled. However, research requires adherence to certain regulations including institutional review board (IRB) oversight to ensure that the proposed research methods are ethical.
Determining when the line is crossed between medical treatment and clinical research can be a difficult task. For instance, if a clinician deals with a single patient and uses a drug off-label during treatment for generalizable knowledge, this act may typically be considered the practice of medicine. However, the instant that a clinician makes generalizable claims about off-label prescriptions, this may constitute research and require IRB oversight.
One way in which we can distinguish research and medicine is through intent. For clinical research, the intention is to answer specific questions through research and potentially benefit future patients and clinical research trials. Medical treatment aims to meet the needs of individual and current patients.
What are the main differences?
Although intent and generalizable knowledge are some key differences between research and medicine, there are several other ways of distinguishing between the two terms.
The current patient (or a third-party payer on the patient’s behalf) usually pays for the medical treatment, and drug developers or government agencies typically fund clinical research.
Clinical research is often performed under a protocol, so timelines are very structured, whereas medical treatment typically requires real-time decisions.
Clinical research comprises an ongoing, systematic assessment of patient data. In comparison, medical treatment involves an assessment of patient data only when needed.
State boards of medicine, professional standards, peer review, informed consent and legal regulations provide guidelines for medical treatment whereas products and procedures regarded as “safe” by the medical community provide the guidelines for clinical research.
Whereas clinical research is often confidential intellectual property, product labeling makes medical treatment available to the general public.
Medical journals typically publish the results of clinical research. However, medical treatments are not generally available to the public.
Because of the different regulations guiding research and medicine, it is important that companies and individuals learn to distinguish between the two terms. Mistaking research for medicine can mean that proper oversight is not given, and a company or individual may fall out of compliance as a result.
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I also host a podcast called DarshanTalks, a show that discusses newsworthy FDA issues and how they apply to bringing a product to market – and keeping it there. From patient centricity in clinical trials to the government shutdown to CRISPR and bioethics to why big data is doomed to fail in healthcare, we’ve got quite the list of topics to review! Listen to the podcast on Google Podcasts or on Apple Podcasts.