Guidances for statistics in regulatory affairs information
Guidances for statistics in regulatory affairs refers to specific documents or guidelines that provide instructions, recommendations, and standards pertaining to the application of statistical methodologies and practices within the regulatory framework of industries such as pharmaceuticals and medical devices. These guidances serve as a reference for statisticians, researchers, and professionals involved in designing, conducting, analyzing, and reporting studies and trials in compliance with regulatory requirements. These documents embody the prevailing perspectives of regulatory agencies on specific subjects. It is worth noting that in the United States, the term "Guidances" is used, while in Europe, the term "Guidelines" is employed.
Regulatory affairs, alternatively referred to as government affairs, constitutes a profession within regulated sectors like pharmaceuticals and medical devices. Professionals, including statisticians, in these fields are expected to incorporate regulatory guidance into their work practices.
Statisticians operating in regulated environments, such as the pharmaceutical and healthcare industries, are required to possess a comprehensive understanding of the regulatory requirements influencing the design, execution, analysis, and reporting of their studies.[1]
Regulatory guidance pertinent to the pharmaceutical and medical devices industries can be found at both international and regional/national levels. Examples of regulatory bodies include the European Medicines Agency (EMA) in Europe, the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom, the Institute for Quality and Efficiency in Health Care (IQWiG) in Germany, the Food and Drug Administration (FDA) in the United States, and the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan.
Additionally, statistical regulatory guidance is available for general topics such as Good Clinical Practice (ICH E6(R2)),[2] as well as specific areas explicitly related to statistics, such as Statistical Principles for Clinical Trials (ICH E9),[3] and some indirectly related areas like Special Populations: Geriatrics (ICH E7)[4] or Clinical Trial Endpoints in Oncology (FDA).[5] The extensive array of regulatory guidance, encompassing both draft and final versions, undergoes periodic revisions. Consequently, users of these guidance documents are advised to consult the original websites to access the most up-to-date versions.
^Gerlinger, C., Edler, L., Friede, T., Kieser, M., Nakas, C.T., Schumacher, M., Seldrup, J. and Victor, N. (2012). "Considerations on what constitutes a "Qualified Statistician" in regulatory guidelines". Statistics in Medicine. 31 (11–12): 1303–1305. doi:10.1002/sim.4345. PMID 21948351. S2CID 39562170.{{cite journal}}: CS1 maint: multiple names: authors list (link)
^ICH E6(R2) - Good clinical practice (GCP)
^ICH E9 - Statistical Principles for Clinical Trials
^ICH E7 - Studies in support of special populations: geriatrics
^FDA - Clinical trial endpoints for the approval of cancer drugs and biologics
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