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  • The Belmont Report | HHS. gov
    The Belmont Report was written by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research The Commission, created as a result of the National Research Act of 1974, was charged with identifying the basic ethical principles that should underlie the conduct of biomedical and behavioral research involving human subjects and developing guidelines to
  • GUIDELINE FOR THE FORMAT AND CONTENT OF THE CLINICAL AND STATISTICAL . . .
    I INTRODUCTION This guideline is intended to assist an applicant in presenting the clinical and statistical data required as part of an application under 21 CFR 314 50 The guideline describes an acceptable format for organi zing the clinical and statistical sections and presenting the clinical and statistical information and accompanying statistical documentation of a clinical trial With
  • Physician Compare Fact Sheet - HHS. gov
    Be statistically valid, reliable, and accurate, Be comparable across collection types; and Meet the minimum reliability threshold, as determined by statistical testing
  • Implementing Gold Standard Science - HHS. gov
    Executive Summary Reliable and accurate scientific information is a cornerstone of effective policy- and decision- making The U S Department of Health and Human Services (HHS or the Department) takes seriously the responsibility to conduct and support scientific activities to the highest standard and to foster public trust in federally funded science In alignment with the May 23, 2025
  • Office of Medicare Hearings and Appeals Statistical Sampling Initiative
    Statistical sampling draws a random sample from a collection of claims and extrapolates (in other words, projects) the results of the sample to the entire “universe” of claims OMHA statistical sampling is conducted using a trained and experienced statistical expert to develop the appropriate sampling methodology in accordance with Medicare guidance, and randomly select the sample units
  • 2014. 10. 30 In the Case of Sans Bois Health Services, Inc - HHS. gov
    The ALJ erred as a matter of law in determining the sample was not statistically valid solely because the same random number seed was used to select samples in both strata and reserves
  • HHS Advances Women’s Health, Removes Misleading FDA . . . - HHS. gov
    Women have used HRT products for decades to relieve menopausal symptoms However, their use plummeted in the early 2000s when the FDA applied boxed warnings following a Women’s Health Initiative study that found a statistically non-significant increase in the risk of breast cancer diagnosis The average age of women in the study was 63 years — over a decade past the average age of a woman
  • Decision Memo - HHS. gov
    Page 2 - DECISION REQUESTED - Adopting Revised Childhood and Adolescent Immunization Schedule officials at CDC, FDA, the National Institutes of Health (NIH), and the Centers for Medicare and Medicaid Services (CMS) After a careful review of the current U S childhood and adolescent immunization schedule, peer nations' schedules and best practices, and the underlying evidence and data, TAB 1
  • Exposure-Response Relationships Study Design, Data Analysis, and . . .
    In principle, being able to detect a statistically significant difference in pairwise comparisons between doses is not necessary if a statistically significant trend (upward slope) across doses can be established, as described in the ICH E4 guidance on dose-response
  • Considerations in Demonstrating Interchangeability With a Reference . . .
    The log-transformed AUCtau and Cmax data should be statistically analyzed using an average equivalence statistical approach 24 The 90% confidence interval for the geometric mean ratio of AUCtau (IV and SC data) and Cmax (SC data) between the proposed interchangeable product and the reference product should be within 80% to 125% Ctrough and Tmax





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