When Does Innovative Care Become Clinical Research?

Understanding when medical care crosses an unmarked border into clinical research is an important aspect of patient protection and regulatory compliance.

It is axiomatic, because we work in clinical research, that we think we know what clinical research is. It's too fundamental an issue, too basic a concept, to give it much thought. However, there are compounds administered to patients (not subjects), as well as procedures performed on patients that are unapproved, untested, and could in no way be considered the generally accepted standard of care. These therapies, albeit well intentioned, are largely unreviewed for scientific merit. For example, a physician hears from a colleague that off-label use of a drug might be helpful in treating a patient's clinical condition and so prescribes the drug for this off-label indication. There are no statutory prohibitions on this approach, and the physician feels that he or she is in the best position to make this determination. Regulatory agencies are loath to interfere with these kinds of clinical approaches, lest innovative care be stifled.

Innovation and experimentation are part of the daily life of some physicians and dentists. They may inadvertently cross the line from innovative care to clinical research. Both medical and dental activities are regulated by state law regarding their practice, but clinical research has additional GCP requirements, including FDA and IRB oversight. Individual patients may benefit from innovative care, but society also benefits from innovative clinical research; individual patients must be protected from substandard care and research subjects must additionally be protected from substandard research. So there are significant differences in processes and procedures applied to specific clinical situations depending upon a regulatory agency, sponsor, or IRB determination of whether it is innovative care or clinical research.

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