Recommendations

This collection of recommendations and templates may be of interest and assistance to the wider diagnostics research community.

• Performance Standards Reporting Requirements for Essential Assays in Clinical Trials
  This document describes assay data that must be included in protocols submitted to the NCI for support of clinical trials that use those assays to guide patient treatment.
• Enhancing the QUAlity and Transparency of Health Research (EQUATOR) Network 
  The EQUATOR network is an international initiative that seeks to improve the reliability and value of published health research literature by promoting transparent and accurate reporting and wider use of robust reporting guidelines.
• REporting recommendations for tumor MARKer prognostic studies (REMARK)  and the REMARK Explanation and Elaboration 
  These guidelines were simultaneously published in multiple journals with the goal of encouraging transparent and complete reporting of results from tumor marker studies so that all relevant information is available for adequate assessment of the data and/or the generalizability of study results.
• Consolidated Standards of Reporting Trials (CONSORT) 
  The CONSORT 2010 guideline provides standard recommendations for reporting randomized trials, including reports of findings and the methodology of trial design, reporting, and interpretation.
• Standards for the Reporting of Diagnostic Accuracy Studies (STARD) 2015 
  STARD includes an essential list of 30 items that should be included in every report of a diagnostic accuracy study, as an updated version of the previous 2003 STARD Statement.
• Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) 
  STROBE provides a checklist of information for inclusion in reports of observational research studies, developed through collaboration between epidemiologists, methodologists, statisticians, researchers, and journal editors.
• Minimum Information Specification for in situ Hybridization and Immunohistochemistry Experiments (MISFISHIE) 
  MISFISHIE describes six types of information to be provided for gene expression localization experiments: experimental design, biomaterials and treatments, reporters, staining, imaging data and image characterizations.
• Harmonizing Cell-Free DNA Collection and Processing Practices through Evidence-Based Guidance
  BBRB staff worked with outside experts on this publication to put forward best practices for cell-free DNA biospecimen collection and processing.
• Biospecimen Evidence-based Practice (BEBP)
  The NCI BEBP series is an expanding collection of procedural guidelines developed using, and annotated with, evidence from primary research publications in the field of human Biospecimen Science.
• A series of templates for documenting the characteristics of molecular diagnostic assays proposed for use in NCI-funded clinical trials