- NLM Digital Collections - Technical specifications for submitting clinical trial data sets for treatment of ...Publication: [Silver Spring, MD] : Center for Drug Evaluation and Research, January 2022Technical specifications for submitting clinical trial data sets for treatment of noncirrhotic nonalcoholic steatohepatitis (NASH) ... Technical specifications for submitting clinical trial data sets for ... for industry United States. Department of Health and Human Services United ...
- NLM Digital Collections - An evidence-based health care system : the case for clinical trials registries : Office of ...Publication: [Bethesda, Md. : Office of Medical Applications of Research?, 1993]... this evolution on the definition and interpretation of clinical trial data. Third, I will present an overview of the ... reviewed. If there are available journals that represent clinical trial data, please let us know, and we will oe ...
- NLM Digital Collections - Disease-modifying therapies for relapsing-remitting and primary-progressive multiple ...Publication: Boston, MA : Institute for Clinical and Economic Review, March 6, 2017... the independent review of the full set of clinical trial data performed by the FDA will be invaluable in ... inflation without new evidence of improved outcomes. • Leverage clinical trial data to identify characteristics that determine which patients are ...
- NLM Digital Collections - Chronic hepatitis C virus infection : developing direct-acting antiviral drugs for treatmentPublication: Silver Spring, MD : Center for Drug Evaluation and Research, November 2017... Nonbinding Recommendations injection drug use so that the clinical trial data can reflect the spectrum of patients who will ... resistance compared to single drugs • Early phase 2 clinical trial data showing that the addition of a drug to ...
- NLM Digital Collections - Use of real-world evidence to support regulatory decision-making for medical devices : ...Publication: Silver Spring, MD : Center for Devices and Radiological Health, August 31, 2017... clinical data, adverse event reports, secondary use of clinical trial data (e.g., post hoc analyses), or systematic literature ... was approved based on prospective, randomized, and controlled clinical trial data. Early in the PMA review process, the manufacturer ...
- ... derived from a computerized data management system for clinical trials data. Elting LS, et al. Proc Annu Symp Comput ... derived from a computerized data management system for clinical trials data. Elting LS, et al. Proc Annu Symp Comput ...
- NLM Digital Collections - Targeted immune modulators for rheumatoid arthritis : effectiveness and value : evidence ...Publication: [Boston, Massachusetts] : Institute for Clinical and Economic Review, April 7, 2017... subcutaneous abatacept in rheumatoid arthritis: integrated analysis of clinical trial data representing more than four years of treatment. Arthritis & ... biologics. The ICER arthritis report uses short-term clinical trial data and ignores the nearly two-decades-old benefits ...
- NLM Digital Collections - The comparative clinical effectiveness and value of simeprevir and sofosbuvir in the ...Publication: [Boston, MA] : Institute for Clinical and Economic Review, April 15, 2014... of discontinuation due to adverse events from available clinical trial data, we assumed equally across all drug regimens that ... PR None 1 Naïve/Exp Yes 12 The clinical trial data for sofosbuvir are more complex (see Table 4 ...
- 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... in the Declaration of Helsinki, and that the clinical trial data are credible. The objective of this ICH GCP ... Organization. This guidance should be followed when generating clinical trial data that are intended to be submitted to regulatory ...
- NLM Digital Collections - Refocusing the research enterprise in a changing health ecosystemPublication: Atlanta, GA : Woodruff Health Sciences Center, Emory University, 2015... with Yale to make ano- Johnson & Johnson nymized clinical trial data accessible to research- With more than $71 billion ... J Atlanta: Emory University; 2007. Available at http:// Clinical Trial Data Sharing Agreement with Yale School www.whsc.emory. ...
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