The CONSORT Statement is an evidence-based, minimum set of recommendations for reporting RCTs. It offers a standard way to prepare reports of trial findings, facilitating their complete and transparent reporting, and aiding their critical appraisal and interpretation. 

 

The standard CONSORT statement focuses on trials in which individual participants are randomly assigned to study groups. This extension of the CONSORT statement concerns situations where it is preferable to randomly assign groups (such as patients clustered in medical practices).

 

Another extension of the CONSORT statement intended to improve the reporting of noninferiority and equivalence trials - the article explains the rationale for such trials and provides illustrative examples of good reporting practice.

 

This extension of the CONSORT statement is intended to improve the reporting of pragmatic trials - broadly defined as a randomised controlled trial whose purpose is to inform decisions about practice.

 

The CONSORT-PRO extention is intende to give guidance on the reporting of patient-reported outcomes (PROs) as proposed by the Enhancing the Quality and Transparency of Health Research (EQUATOR) Network.

 

The STROBE statement stands for an international, collaborative initiative of specialist involved in STrengthening the Reporting of OBservational studies in Epidemiology.

 

The STREGA recommendations (STrengthening the REporting of Genetic Association studies) provides additions to 12 of the 22 items of the STROBE statement.

 

The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate healthcare interventions is an update and expansion of the QUOROM statement published in 1999. See the PRISMA checklist and flow diagram.

 

Ethical Guidelines for Statistical Practice, prepared by the Committee on Professional Ethics and approved by the Board of Directors, August 7, 1999. These guidelines are intended to help statistics practitioners make and communicate ethical decisions and include: "Exposure of dishonest or incompetent uses of statistics."

This guidance on statistical principles drafted by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), is written primarily to attempt to harmonise the principles of  statistical methodology applied to clinical trials for marketing applications submitted in Europe, Japan and the United States. This document on statistical issues related to clinical trials underlines the role of statistics in clinical trial design and analysis. The focus of this guidance is on statistical principles. It does not address the use of specific statistical procedures or methods. 

This guideline by the European Medicins Agancy, Committee for Medicinal Products for Human Use (CHMP), was drafted in 2011 and outlines general recommendations on acceptable frameworks for handling missing data. It is important that an analysis is provided for which it is judged that it is unlikely that it is biased in favour of the experimental treatment (i.e. the method can be considered ‘conservative’). 

The Committee for Medicinal Products for Human Use (CHMP), a committee of the European Medicines Agency, drafted the guideline on adjustment for baseline covariates in 2013. The guideline aims to clarify when and why baseline covariates should be included in the primary analysis that will be specified in the protocol, and how the results in the study report should be presented and interpreted.