Limited Clinical Investigation Program

A Limited Clinical Investigation Program is a Research Program that is a Clinical Research Task which enrolls a limited number of test subjects to evaluate the feasibility and preliminary clinical safety of a new medical intervention/treatment or medical device.

• Context:
  • It (typically) requires approval of an institutional review board.
• Example(s):
  • Early Feasibility Studies (EFS) Program,
  • Investigational Device Exemption (IDE) Program,
  • Investigational New Drug (IND) Program,
  • …
• Counter-Example(s):
  • Large-Simple Clinical Trial,
  • Preclinical Trial,
  • Phase-0 Clinical Trial,
  • Phase-I Clinical Trial,
  • Phase-II Clinical Trial,
  • Phase-III Clinical Trial,
  • Phase-IV Clinical Trial.
• See: Drug Development Clinical Trial, Medical Device Development Clinical Trial, Clinical Efficacy, Clinical Effectiveness, Equivalency Clinical Trial.

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References

2022

• (FDA, 2022) ⇒ https://www.fda.gov/medical-devices/investigational-device-exemption-ide/early-feasibility-studies-efs-program Retrieved:2022-1-22.
  • QUOTE: An early feasibility study (EFS) is a limited clinical investigation of a device early in development. It typically:
    • enrolls a small number of subjects;
    • is used to evaluate the device design concept with respect to initial clinical safety and device functionality;
    • and may guide device modifications.

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