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  2. Consolidated Standards of Reporting Trials - Wikipedia

    en.wikipedia.org/wiki/Consolidated_Standards_of...

    The main product of the CONSORT Group is the CONSORT Statement, [1] which is an evidence-based, minimum set of recommendations for reporting randomized trials.It offers a standard way for authors to prepare reports of trial findings, facilitating their complete and transparent reporting, reducing the influence of bias on their results, and aiding their critical appraisal and interpretation.

  3. List of Guidances for Statistics in Regulatory Affairs

    en.wikipedia.org/wiki/List_of_Guidances_for...

    FDA: Clinical trial endpoints for the approval of cancer drugs and biologics [17] provides recommendations to applicants on endpoints for cancer clinical trials submitted to the Food and Drug Administration (FDA) to support effectiveness claims in new drug applications (NDAs), biologics license applications (BLAs), or supplemental applications.

  4. Preferred Reporting Items for Systematic Reviews and Meta ...

    en.wikipedia.org/wiki/Preferred_reporting_items...

    The aim of the PRISMA statement is to help authors improve the reporting of systematic reviews and meta-analyses. [3] PRISMA has mainly focused on systematic reviews and meta-analysis of randomized trials, but it can also be used as a basis for reporting reviews of other types of research (e.g., diagnostic studies, observational studies).

  5. EQUATOR Network - Wikipedia

    en.wikipedia.org/wiki/EQUATOR_Network

    The EQUATOR Network developed and maintains a comprehensive library that provides a collection of publications related to reporting guidelines on scientific writing, empirical evidence supporting or refuting the inclusion of crucial items in reporting guidelines, evaluations of the quality of reporting, publication ethics and educational materials and tools for editors, peer reviewers and ...

  6. Good clinical practice - Wikipedia

    en.wikipedia.org/wiki/Good_clinical_practice

    A similar guideline for clinical trials of medical devices is the international standard ISO 14155, which is valid in the European Union as a harmonized standard. These standards for clinical trials are sometimes referred to as ICH-GCP or ISO-GCP to differentiate between the two and the lowest grade of recommendation in clinical guidelines.

  7. Clinical study report - Wikipedia

    en.wikipedia.org/wiki/Clinical_study_report

    In medicine, a clinical study report (CSR) on a clinical trial is a document, typically very long, providing much detail about the methods and results of a trial. A CSR is a scientific document addressing efficacy and safety, not a sales or marketing tool; its content is similar to that of a peer-reviewed academic paper. [1]

  8. ICMJE recommendations - Wikipedia

    en.wikipedia.org/wiki/ICMJE_recommendations

    The ICMJE recommendations (full title, "Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals") are a set of guidelines produced by the International Committee of Medical Journal Editors for standardising the ethics, preparation and formatting of manuscripts submitted to biomedical journals for publication. [1]

  9. Strengthening the reporting of observational studies in ...

    en.wikipedia.org/wiki/Strengthening_the...

    The STROBE Statement has also been adapted as a public, open-source repository for epidemiological research methods and reporting skills for observational studies. Epidemiologists, statisticians, and public health researchers are able to comment and edit the tool to inform future updates of the reporting guideline. [27]