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9,105 results
  1. NLM Digital Collections - E6(R2) good clinical practice : integrated addendum to ICH E6(R1) 
    Publication: Silver Spring, MD : Center for Drug Evaluation and Research, March 2018
    ... or Suspension of a Trial ........................................... 38 5.22 Clinical Trial/Study Reports ................................................................................. 38 5.23 Multicenter Trials.................................................................................................... 38 6. CLINICAL ...
  2. ... intended to make the data reports from this study comparable with clinical trial reports. To meet these objectives, data elements (e.g., ...
  3. ... outcomes: a comparison of journal publications with unpublished clinical study reports of orlistat trials. Trials. 2016;17(207). doi:10.1186/s13063- ... range of sources, including observational studies, particularly when clinical ... assess and report benefits are appropriate; rather, evaluate how well studies ...
  4. ... in HTA. E. Personalized Health Care and HTA Clinical trials and other studies that report only average treatment effects may be misleading. Therapies ...
  5. ... Summary and Implications Skin Substitutes Being Examined in Clinical Trials Of the 76 commercially available skin substitutes relevant to this report, included studies and ongoing clinical trials will have examined approximately ...
  6. ... conducted. Publications have taken the form of case reports , phase I clinical trials , toxicity studies, and phase II clinical trials . Phase I toxicity ... administration and infusion of A10.[ 18 ] Comment on ... or series, phase I clinical trials, and phase II clinical trials, conducted mainly ...
  7. ... iii or clinical trial, phase iv or controlled clinical trial or evaluation studies or meta analysis or multicenter study or randomized controlled trial or technical report or validation studies) exp epidemiologic study characteristics/ exp ...
  8. ... either the United States or a foreign country. Clinical Trial, Phase IV Work that is a report of a planned post-marketing study of diagnostic, therapeutic, or prophylactic drugs, devices, or ...
  9. ... studies is not as strong as evidence from clinical trials or cohort studies. Ecologic studies Ecologic studies report information collected on entire groups of people, such ...
  10. NLM Digital Collections - Investigational enzyme replacement therapy products : nonclinical assessment 
    Publication: Silver Spring, MD : Center for Drug Evaluation and Research, October 2019
    ... studies with safety information are used to support clinical trials. Each complete study report should include, but not be limited to, the ...
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