Guidelines

The world of evidence is changing, with regulators and payers increasingly seeking the demonstration of value beyond clinical outcomes. YOLARX provides below a selection of guidelines and guidance documents established by international pharmacoepidemiology societies or organisations and regulators. They are listed in order of appearance with the most recent publication on top.

YOLARX has created these links for educational and research purposes only, and cannot take responsibility for content of third party web sites. Inclusion of a link does not imply endorsement of or association with YOLARX.

Pharmacoepidemiology and clinical studies:

• Guide on Methodological Standards in Pharmacoepidemiology (Revision 11, July 2023); European Medicines Agency (EMA)/European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP); last accessed 18 July 2023

• International Ethical Guidelines for Health-related Research Involving Humans (2016); Council for International Organizations of Medical Sciences (CIOMS) in collaboration with the World Health Organization (WHO); last accessed on 01 November 2022

• Guidelines for Good Pharmacoepidemiology Practices (GPP) (Revision 3, June 2015); ISPE – International Society of Pharmacoepidemiology; last accessed on 01 November 2022

• Guidance for Industry and FDA Staff. Best Practices for Conducting and Reporting Pharmacoepidemiologic Safety Studies Using Electronic Healthcare Data (May 2013); Food and Drug Administration (FDA); last accessed on 01 November 2022

• Guidelines for Good Database Selection and Use in Pharmacoepidemiology Research; Hall et al.; Pharmacoepidemiology and drug safety (2011); DOI: 10.1002/pds.2229; last accessed on 01 November 20222

• ICH Harmonized Tripartite Guideline. Statistical Principles for Clinical Trials E9 (1998); International Conference on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use; last accessed on 01 November 2022

• ICH Harmonized Tripartite Guideline. Addendum: Statistical Principles for Clinical Trials E9(R1) (2019); International Conference on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use; last accessed on 01 November 2022

• ICH Harmonized Tripartite Guideline. Structure and Content of Clinical Study Reports E3 (1995); International Conference on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use; last accessed on 01 November 2022

• Community code relating to veterinary medicinal products. Directive 2001/82/EC of 6 November 2001; Official Journal of the European Union; last accessed on 01 November 2022

• Food and Drug Administration (FDA) Good Clinical Practice (GCP). Electronic Records; Electronic Signatures (21 CFR Part 11); last accessed on 01 November 2022

Pharmacovigilance and risk management:

• Guideline on Good Pharmacovigilance Practices (GVP) Module VIII – Post Authorisation Safety Studies (Revision 3, October 2017); European Medicines Agency (EMA)/Heads of Medicines Agencies (HMA); last accessed on 01 November 2022

• Guideline on Good Pharmacovigilance Practices (GVP) Module VIII Addendum I – Requirements and recommendations for the submission of information on non-interventional post-authorisation safety studies (Revision 3, June 2020); European Medicines Agency (EMA)/Heads of Medicines Agencies (HMA); last accessed on 01 November 2022

• Practical approaches to risk minimisation for medicinal products: Report of CIOMS Working Group IX.  Geneva, Switzerland: Council for International Organizations of Medical Sciences (CIOMS), 2014. last accessed on 01 November 2022

• Performance of Pharmacovigilance Activities. Commission Implementing Regulation (EU) No 520/2012 of 19 June 2012; Official Journal of the European Union; last accessed on 01 November 2022

• EU Pharmacovigilance Legislation (2012); last accessed on 01 November 2022

• European Medicines Agency (EMA) Good Pharmacovigilance Practice (GVP); last accessed on 01 November 2022

• Food and Drug Administration (FDA) Guidance for Industry. Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment (March 2005); last accessed on 01 November 2022

• ICH Harmonized Tripartite Guideline. Pharmacovigilance Planning E2E (2004); International Conference on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use; last accessed on 01 November 2022

Systematic reviews and meta-analyses:

• PRISMA 2020 Statement for Reporting Systematic Reviews: Page MJ, et al. The PRISMA 2020 statement: an updated guideline for reporting systematic reviews. BMJ. 2021 Mar 29;372:n71. doi: 10.1136/bmj.n71; last accessed on 01 November 2022

• PRISMA for Systematic Review Protocols (PRISMA-P): Moher D, et al. Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols (PRISMA-P) 2015 statement. Syst Rev. 2015;4(1):1. doi: 10.1186/2046-4053-4-1; last accessed on 01 November 2022

• Preferred Reporting Items for Systematic Reviews and Meta-Analyses: The PRISMA Statement; Moher D, Liberati A, Tetzlaff J, Altman DG, The PRISMA Group (2009). BMJ 2009;339:b2535, doi: 10.1136/bmj.b2535; last accessed on 01 November 2022

• The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) Statement; last accessed on 01 November 2022

• The Meta-analysis Of Observational Studies in Epidemiology (MOOSE) Statement (2000); Stroup DF et al. Meta-analysis Of Observational Studies in Epidemiology (MOOSE) group. JAMA 2000; 283, pp. 2008–12. doi:10.1001/jama.283.15.2008; last accessed on 01 November 2022

Rapid & scoping reviews:

• Cochrane Recommendations for Rapid Reviews (2020); Garritty C, et al. Cochrane Rapid Reviews Methods Group offers evidence-informed guidance to conduct rapid reviews. J Clin Epidemiol. 2021 Feb;130:13-22. doi: 10.1016/j.jclinepi.2020.10.007. Epub 2020 Oct 15; last accessed on 01 November 2022

• PRISMA extension for scoping reviews (PRISMA-ScR): checklist and explanation (2018); Tricco, AC, Lillie, E, Zarin, W, O’Brien, KK, Colquhoun, H, Levac, D, Moher, D, Peters, MD, Horsley, T, Weeks, L, Hempel, S et al. PRISMA extension for scoping reviews (PRISMA-ScR): checklist and explanation. Ann Intern Med. 2018,169(7):467-473. doi:10.7326/M18-0850; last accessed on 01 November 2022