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1,513 results
  1. Results - Treatments for Schizophrenia in Adults: A Systematic Review - NCBI Bookshelf 
    https://www.ncbi.nlm.nih.gov/books/NBK487633
    ... is insufficient due to study limitations, lack of confirmatory trials, and imprecision. Improvement in Core Illness Symptoms Overall ... draw conclusions due to methodological limitations, lack of confirmatory trials, and imprecision. Unable To Live Independently Based on ...
  2. Executive Summary - Future Research Needs for Comparative Effectiveness of Treatments of Localized Prostate Cancer - ... 
    https://www.ncbi.nlm.nih.gov/books/NBK51319
    ... RCTs comparing primary treatments for localized prostate cancer Confirmatory trials where RCTs are available Outcomes Standardized reporting of ...
  3. NLM Digital Collections - Pathological complete response in neoadjuvant treatment of high-risk early-stage breast ... 
    Publication: [Silver Spring, MD] : United States Food and Drug Administration, Oncology Center of Excellence, July 2020
    resource.nlm.nih.gov/9918227256906676
    ... Clinical Trials to Verify and Describe Clinical Benefit (Confirmatory Trials).............................110 5. Selecting a Development Strategy: Single Trial ...
  4. NLM Digital Collections - Strengthening the accelerated approval pathway : an analysis of potential policy reforms and .... 
    Publication: [Boston, Massachusetts] : Institute for Clinical and Economic Review, April 26, 2021
    resource.nlm.nih.gov/9918402188806676
    ... 2 5. Increase Enforcement of Requirements to Complete Confirmatory Trials ............................. 28 6. Create an Annual Renewal Cycle or ... Pricing at Marginal Cost to Incentivize Completion of Confirmatory Trials, with Consideration of a Federal Carve-Out ......................................................................................... 31 ...
  5. Breast Cancer Treatment (Adult) (PDQ®) - PDQ Cancer Information Summaries - NCBI Bookshelf 
    https://www.ncbi.nlm.nih.gov/books/NBK65744
    ... breakthrough therapy designation for sacituzumab govitecan, and a confirmatory randomized trial is under way. Cardiac toxic effects with anthracyclines ...
  6. NLM Digital Collections - BCG-unresponsive nonmuscle invasive bladder cancer : developing drugs and biologics for ... 
    Publication: Silver Spring, MD : Center for Drug Evaluation and Research, February 2018
    resource.nlm.nih.gov/101733968
    ... for regular approval, or it may require a confirmatory trial after approval. 5 A confirmatory, randomized trial in ... induction course of BCG. The need for a confirmatory trial and its design can be discussed at a ...
  7. NLM Digital Collections - Adaptive designs for clinical trials of drugs and biologics 
    Publication: Silver Spring, MD : Center for Drug Evaluation and Research, November 2019
    resource.nlm.nih.gov/101760568
    ... optimal dose or doses for evaluation in future confirmatory trials. For example, the continual reassessment method (CRM) is ... lead to suboptimal dose selection for a subsequent confirmatory trial, with a resultant failure to show effectiveness or ...
  8. NLM Digital Collections - Aducanumab for Alzheimer’s disease : effectiveness and value 
    Publication: [Boston, Massachusetts] : Institute for Clinical and Economic Review, August 5, 2021
    resource.nlm.nih.gov/9918401087306676
    ... years the FDA allowed Biogen to complete its confirmatory trial. Regulatory For AD, the FDA should act quickly ... be contingent upon verification of clinical benefit in confirmatory trial(s). Assessing the first treatment for Alzheimer's disease is ...
  9. NLM Digital Collections - E17 general principles for planning and design of multiregional clinical trials 
    Publication: Silver Spring, MD : Center for Drug Evaluation and Research, July 2018
    resource.nlm.nih.gov/101734380
    ... about them should also be collected during the confirmatory trial for evaluation of their impact on treatment effects. ... about these factors should be collected during the confirmatory trial for later evaluation of their impact on treatment ...
  10. NLM Digital Collections - COVID-19 : developing drugs and biological products for treatment or prevention 
    Publication: Silver Spring, MD : Center for Drug Evaluation and Research, February 2021
    resource.nlm.nih.gov/9918231202706676
    ... a proof-of- concept phase to a larger confirmatory trial). Such a trial might also incorporate additional prospectively ... futility (lack of efficacy) or harm in any confirmatory trial. The stopping criteria should aim to ensure a ...
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