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  3. www.cancer.org › phases-of-clinical-trialsTypes and Phases of Clinical Trials - American Cancer Society

    In the United States, when phase III clinical trials (or sometimes phase II trials) show a new drug is more effective or safer than the current treatment, a new drug application (NDA) is submitted to the Food and Drug Administration (FDA) for approval.

  4. www.healthline.com › health › clinical-trial-phasesClinical Trial Phases: What Happens in Phase 0, I, II, III ...

    Feb 22, 2018 · During phase I of a clinical trial, investigators spend several months looking at the effects of the medication on about 20 to 80 people who have no underlying health conditions. This phase...

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  5. www.cancer.net › phases-clinical-trialsPhases of Clinical Trials | Cancer.Net

    Phase II clinical trials. A phase II clinical trial tells doctors more about how safe the treatment is and how well it works. Doctors also test whether a new treatment works for a specific cancer. They might measure the tumor, take blood samples, or check how well you can do certain activities.

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  7. www.nih.gov › health-information › nih-clinicalThe Basics | National Institutes of Health (NIH)

    Oct 3, 2022 · Phase I trials: Researchers test a drug or treatment in a small group of people (20–80) for the first time. The purpose is to study the drug or treatment to learn about safety and identify side effects.

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  8. www.fda.gov › basics-about-clinical-trialsBasics About Clinical Trials | FDA

    May 8, 2023 · Talk to the clinical trial coordinator to find out which phase the clinical trial is in. Learn more about the different clinical trial phases and whether they are right for you.

  9. www.nature.com › articles › s41416/021/01412-yRandomised Phase 1 clinical trials in oncology | British ...

    Jun 10, 2021 · This article articulates the role or randomisation in early phase trials where the goal is to go beyond the simple comparison of different drugs. We provide examples of relevant, timely...

  10. www.nature.com › articles › nrclinoncThe changing landscape of phase I trials in oncology

    Nov 10, 2015 · Current phase I trial designs increasingly use new dose-escalation approaches and biomarker-driven patient selection, while expanding study objectives to include efficacy evaluation and...

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