Clinical research

Clinical research is scientific research involving human participants (or human-derived material) that aims to generate knowledge about health, disease, medical interventions, or healthcare. It includes patient-oriented research, epidemiologic and behavioral studies, outcomes research and health services research.

Definitions

NIH Director’s Panel on Clinical Research

The U.S. National Institutes of Health (NIH), based on the 1997 Report of the NIH Director’s Panel on Clinical Research, define clinical research as:

  1. Patient-oriented research. Research conducted with human subjects (or on material of human origin such as tissues, specimens and cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects. This area of research includes:
    • Mechanisms of human disease
    • Therapeutic interventions
    • Clinical trials
    • Development of new technologies
  2. Epidemiologic and behavioral studies
  3. Outcomes research and health services research

Excluded from this definition are in vitro studies that utilize human tissues but do not deal directly with patients 1.

U.S. regulatory definitions

FDA: Clinical investigation

Under 21 CFR 50.3(c), the U.S. Food and Drug Administration (FDA) defines clinical investigation as follows:

Clinical investigation means any experiment that involves a test article and one or more human subjects and that either is subject to requirements for prior submission to the Food and Drug Administration under section 505(i) or 520(g) of the act, or is not subject to requirements for prior submission to the Food and Drug Administration under these sections of the act, but the results of which are intended to be submitted later to, or held for inspection by, the Food and Drug Administration as part of an application for a research or marketing permit 2.

Under 21 CFR 50.3(c) and 21 CFR 56.102(c), the terms research, clinical research, clinical study, study, and clinical investigation are treated as synonymous for the purposes of these regulations 3.

HHS: Research

Under 45 CFR 46.102(l), the U.S. Department of Health and Human Services (HHS) defines research as follows:

Research means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge 4.

This definition applies to research governed by the HHS regulations on the protection of human subjects. It defines research generally rather than clinical research specifically.

European Union terminology

Regulation (EU) No 536/2014 defines clinical study and clinical trial in Article 2(2) for the purposes of research involving medicinal products. The Regulation does not establish a general definition of clinical research 5.

Clinical research, clinical studies, and clinical trials

Clinical research is the broad field of scientific investigation involving human participants or human-derived material. Clinical study and clinical trial have more specific meanings under particular scientific and regulatory frameworks.

In EU medicinal product legislation, a clinical trial is a subset of clinical studies that meets the additional conditions specified in Regulation (EU) No 536/2014. In other contexts, the terminology may differ.

Related terminology

  • Clinical study
  • Clinical trial
  • Ethics committee
  • Good clinical practice
  • Informed consent
  • Investigational product
  • Protocol

References

  1. National Institutes of Health (NIH). 1997. Report of the NIH Director’s Panel on Clinical Research. Available at: https://grants.nih.gov/grants/NIH_Directors_Panel_Clinical_Research_Report_199712.pdf ↩︎
  2. U.S. Food and Drug Administration (FDA). 21 CFR Part 50—Protection of Human Subjects, § 50.3(c). Available at: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-50 ↩︎
  3. U.S. Food and Drug Administration (FDA). 21 CFR Part 56—Institutional Review Boards, § 56.102(c). Available at: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-56 ↩︎
  4. U.S. Department of Health and Human Services (HHS). 45 CFR Part 46—Protection of Human Subjects, § 46.102(l). Available at: https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-A/part-46/subpart-A/section-46.102 ↩︎
  5. European Parliament and Council of the European Union. 2014. Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use, Article 2(2). Available at: https://eur-lex.europa.eu/eli/reg/2014/536/oj ↩︎