Tuberculosis — Evaluation of CAD-based Triage for CXR Interpretation During TB Screening
Citation(s)
Milam ME, Koo CW The current status and future of FDA-approved artificial intelligence tools in chest radiology in the United States. Clin Radiol. 2023 Feb;78(2):115-122. doi: 10.1016/j.crad.2022.08.135. Epub 2022 Sep 28.
Potnis KC, Ross JS, Aneja S, Gross CP, Richman IB Artificial Intelligence in Breast Cancer Screening: Evaluation of FDA Device Regulation and Future Recommendations. JAMA Intern Med. 2022 Dec 1;182(12):1306-1312. doi: 10.1001/jamainternmed.2022.4969.
Twilt JJ, van Leeuwen KG, Huisman HJ, Futterer JJ, de Rooij M Artificial Intelligence Based Algorithms for Prostate Cancer Classification and Detection on Magnetic Resonance Imaging: A Narrative Review. Diagnostics (Basel). 2021 May 26;11(6):959. doi: 10.3390/diagnostics11060959.
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.
