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  1. 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
    Adaptive designs for clinical trials of drugs and biologics ... Adaptive designs for clinical trials of drugs and biologics Guidance for industry United States. Department of Health and ...
  2. HTA 101: III. PRIMARY DATA METHODS 
    https://www.nlm.nih.gov/nichsr/hta101/ta10105.html
    ... regimen of a drug or other technology ( FDA Adaptive Design 2010 ; van der Graaf 2012 ). A current example ... 2012 ; Chilcott 2003 ; Claxton 1996 ; Detsky 1990 ; FDA Adaptive Design 2010 ). As noted above, the process of compiling ...
  3. Registry Design - Registries for Evaluating Patient Outcomes - NCBI Bookshelf 
    https://www.ncbi.nlm.nih.gov/books/NBK208632
    ... of adaptive clinical trial design to registries. An adaptive design has been defined as a design that allows ... modified after initiation, the more formal aspects of adaptive trial design have yet to be applied to registries and ...
  4. Appendices - Hypertension in pregnancy: diagnosis and management - NCBI Bookshelf 
    https://www.ncbi.nlm.nih.gov/books/NBK550449
    ... with consideration of a multi-arm, multi-stage adaptive design. Timeframe Minimum three years from completion of index ...
  5. pdfNLM_BOR_CTG_WG_Report_Final_102822_508.pdf 
    https://www.nlm.nih.gov/...LM_BOR_CTG_WG_Report_Final_102822_508.pdf
    ... gov Beta website is being developed with an adaptive design that supports accessibility. • Providing contextual support for ClinicalTrials. ...
  6. Excluded Studies - Venous Thromboembolism Prophylaxis in Major Orthopedic Surgery: Systematic Review Update - NCBI ... 
    https://www.ncbi.nlm.nih.gov/books/NBK476628
    ... C, Pak R, Mandema J, et al An adaptive-design dose-ranging study of PD 0348292, a new ...
  7. NLM Digital Collections - Enrichment strategies for clinical trials to support determination of effectiveness of human .... 
    Publication: Silver Spring, MD : Center for Drug Evaluation and Research, March 2019
    resource.nlm.nih.gov/101760015
    ... the study will successfully meet its objectives. An adaptive design in which the sample size and other design ... the uncertainty 6 The draft guidance for industry Adaptive Designs for Clinical Trials of Drugs and Biologics (September ...
  8. NLM Digital Collections - Technology assessment. Vaccine development : capabilities and challenges for addressing ... 
    Publication: Washington, DC : United States Government Accountability Office, November 2021
    resource.nlm.nih.gov/9918383084506676
    ... to improve trial recruitment industry. and might enable adaptive designs that could speed up clinical trials involving multiple ... future epidemics and pandemics. 51 FDA defines an adaptive design as a clinical trial design that allows for ...
  9. NLM Digital Collections - Amyotrophic lateral sclerosis : developing drugs for treatment 
    Publication: Silver Spring, MD : Center for Drug Evaluation and Research, September 2019
    resource.nlm.nih.gov/101760442
    ... Contains Nonbinding Recommendations the draft guidance for industry Adaptive Designs for Clinical Trials for Drugs and Biologics (September ... development of new drugs. Sponsors should also consider adaptive designs 10 (including the use of Bayesian features) and ...
  10. NLM Digital Collections - Antibacterial therapies for patients with an unmet medical need for the treatment of serious .... 
    Publication: Silver Spring, MD : Center for Drug Evaluation and Research, August 2017
    resource.nlm.nih.gov/101713206
    ... for early stopping based on efficacy or futility. Adaptive design clinical trials or trial designs with features, such ... of the trial; sponsors who are considering an adaptive design are encouraged to consult the draft guidance for ...
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