List of Guidances for Statistics in Regulatory Affairs
This List presents a comprehensive source of references for statistical guidance documents and related articles that are relevant to regulatory affairs for those statisticians that work on clinical studies. The List is associated with the Wikipedia page Guidances for statistics in regulatory affairs that aims to address the various topics of the listed guidances. Regulatory guidances (draft and/or final ) are subject to revisions. Therefore, users of the guidances are advised to consult the original website to check for the latest version. Users are also encouraged to update the Wikipedia List. References classified by statistical topic Good clinical practice ICH E6(R2): Good clinical practice is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. FDA: Good Review Practice: Clinical Review of Investigational New Drug Applications. This good review practice (GRP) document was prepared to assist FDA clinical review staff in reviewing clinical submissions to an investigational new drug application (IND) from the pre-IND phase to the time of the pre-new drug application/biologics license application meeting. Data monitoring committees CHMP/EWP/5872/03: Data monitoring committees (EMA) deals with independent data monitoring committees. It highlights the key issues involved when sponsors include data monitoring committees as a part of their trial management. FDA: Establishment and Operation of Clinical Trial Data Monitoring Committees. This guidance discusses the roles, responsibilities and operating procedures of Data Monitoring Committees (DMCs) (also known as Data and Safety Monitoring Boards (DSMBs) or Data and Safety Monitoring Committees (DSMCs)) that may carry out important aspects of clinical trial monitoring. Adjustment by covariates EMA/CHMP/295050/2013: Adjustment for baseline covariates in clinical trials (EMA) provides advice on how to address important baseline covariates in designing, analysing and reporting clinical trials. It mainly focuses on confirmatory randomised trials. Small populations / rare diseases CHMP/EWP/83561/05: Clinical trials in small populations (EMA) addresses problems associated with clinical trials when there are limited numbers of patients available to study. FDA Rare diseases: Common issues in drug development. Guidance for industry. see also the subgroup analysis section Extrapolation / bridging EMA/199678/2016: Reflection paper on extrapolation of efficacy and safety in paediatric medicine development. EMA/189724/2018: Reflection paper on the use of extrapolation in the development of medicines for paediatrics. EMA/129698/2012: Concept paper on extrapolation of efficacy and safety in medicine development. FDA-2015-D-1376: Leveraging existing clinical data for extrapolation to pediatric uses of medical devices. Guidance for Industry and Food and Drug Administration Staff. ICH E5 (R1): Ethnic factors in the acceptability of foreign clinical data. This document addresses the intrinsic characteristics of the drug recipient and extrinsic characteristics associated with environment and culture that could affect the results of clinical studies carried out in regions and describes the concept of the "bridging study" that a new region may request to determine whether data from another region are applicable to its population. FDA-2016-D-2153: Use of real-world evidence to support regulatory decision-making for medical devices. Guidance for Industry and FDA Staff. Non-inferiority CPMP/EWP/2158/99: Choice of a non-inferiority (EMA) provides guidance