ISPE Policies & Manuscripts
ISPE Policy Manual
Endorsed Manuscripts
Bourke, A., Bate, A., Sauer, B. C., Brown, J. S., and Hall, G. C. (2016) Evidence generation from healthcare databases: recommendations for managing change. Pharmacoepidemiol Drug Saf, 25: 749– 754. https://doi.org/10.1002/pds.4004
Willame, C., Baril, L., van den Bosch, J., Ferreira, G. L. C., Williams, R., Rosillon, D., and Cohet, C. (2016) Importance of feasibility assessments before implementing non?interventional pharmacoepidemiologic studies of vaccines: lessons learned and recommendations for future studies. Pharmacoepidemiol Drug Saf, 25: 1397– 1406. https://doi.org/10.1002/pds.4081
Majid, T., Heath, N., Kim, J. et al. Integrating the patient voice into pharmacoepidemiology research on the benefits and harms of medication. J Public Health (Berl.) (2021). https://doi.org/10.1007/s10389-021-01477-2
Cadarette, SM, Maclure, M, Delaney, JAC, et al. Control yourself: ISPE-endorsed guidance in the application of self-controlled study designs in pharmacoepidemiology. Pharmacoepidemiol Drug Saf. 2021; 30: 671– 684. https://doi.org/10.1002/pds.5227
Issa, AM, Carleton, B, Gerhard, T, et al. Pharmacoepidemiology: A time for a new multidisciplinary approach to precision medicine. Pharmacoepidemiol Drug Saf. 2021; 1– 8. https://doi.org/10.1002/pds.5226
Salas, M, Lopes, LC, Godman, B, et al. Challenges facing drug utilization research in the Latin American region. Pharmacoepidemiol Drug Saf. 2020; 29: 1353– 1363. https://doi.org/10.1002/pds.4989
Pratt, NL, Mack, CD, Meyer, AM, et al. Data linkage in pharmacoepidemiology: A call for rigorous evaluation and reporting. Pharmacoepidemiol Drug Saf. 2020; 29: 9–17. https://doi.org/10.1002/pds.4924
Rivera, DR, Gokhale, MN, Reynolds, MW, et al. Linking electronic health data in pharmacoepidemiology: Appropriateness and feasibility. Pharmacoepidemiol Drug Saf. 2020; 29: 18–29. https://doi.org/10.1002/pds.4918
Langan Sinéad M, Schmidt Sigrún AJ, Wing Kevin, Ehrenstein Vera, Nicholls Stuart G, Filion Kristian B et al. The reporting of studies conducted using observational routinely collected health data statement for pharmacoepidemiology (RECORD-PE) BMJ 2018; 363 :k3532 https://doi.org/10.1136/bmj.k3532
Duszynski, KM, Stark, JH, Cohet, C, et al. Suitability of databases in the Asia?Pacific for collaborative monitoring of vaccine safety. Pharmacoepidemiol Drug Saf. 2021; 1– 15. https://doi.org/10.1002/pds.5214
Bourke, A, Dixon, WG, Roddam, A, et al. Incorporating patient generated health data into pharmacoepidemiological research. Pharmacoepidemiol Drug Saf. 2020; 29: 1540– 1549. https://doi.org/10.1002/pds.5169
Sarri G, Patorno E, Yuan H, et al Framework for the synthesis of non-randomised studies and randomised controlled trials: a guidance on conducting a systematic review and meta-analysis for healthcare decision making. BMJ Evidence-Based Medicine Published Online First: 09 December 2020. doi: 10.1136/bmjebm-2020-111493 http://dx.doi.org/10.1136/bmjebm-2020-111493
Wang, C.-Y., Berlin, J.A., Gertz, B., Davis, K., Li, J., Dreyer, N.A., Zhou, W., Seeger, J.D., Santanello, N. and Winterstein, A.G. (2021), Uncontrolled Extensions of Clinical Trials and the Use of External Controls – scoping opportunities and methods. Clinical Pharmacology & Therapeutics. Accepted Author Manuscript. https://doi.org/10.1002/cpt.2346
Cocoros, N.M., Arlett, P., Dreyer, N.A., Ishiguro, C., Iyasu, S., Sturkenboom, M., Zhou, W. and Toh, S. (2021), The Certainty Framework for Assessing Real?World Data in Studies of Medical Product Safety and Effectiveness. Clin. Pharmacol. Ther. https://doi.org/10.1002/cpt.2045
Wang Shirley V, Pinheiro Simone, Hua Wei, Arlett Peter, Uyama Yoshiaki, Berlin Jesse A et al. STaRT-RWE: structured template for planning and reporting on the implementation of real world evidence studies BMJ 2021; 372 :m4856 https://doi.org/10.1136/bmj.m4856
Franklin, JM, Liaw, K-L, Iyasu, S, Critchlow, CW, Dreyer, NA. Real-world evidence to support regulatory decision making: New or expanded medical product indications. Pharmacoepidemiol Drug Saf. 2021; 30: 685– 693. https://doi.org/10.1002/pds.5222
Real-World Evidence for Assessing Treatment Effectiveness and Safety in Pediatric Populations, Horton, Daniel B. et al. The Journal of Pediatrics, https://doi.org/10.1016/j.jpeds.2021.06.062
Burcu, M., Manzano-Salgado, C.B., Butler, A.M. et al. A Framework for Extension Studies Using Real-World Data to Examine Long-Term Safety and Effectiveness. Ther Innov Regul Sci (2021). https://doi.org/10.1007/s43441-021-00322-8
Wang, SV, Schneeweiss, S, Berger, ML, et al. Reporting to Improve Reproducibility and Facilitate Validity Assessment for Healthcare Database Studies V1.0. Pharmacoepidemiol Drug Saf. 2017; 26: 1018–1032. https://doi.org/10.1002/pds.4295
Berger, ML, Sox, H, Willke, RJ, et al. Good practices for real?world data studies of treatment and/or comparative effectiveness: Recommendations from the joint ISPOR?ISPE Special Task Force on real?world evidence in health care decision making. Pharmacoepidemiol Drug Saf. 2017; 26: 1033–1039. https://doi.org/10.1002/pds.4297
Burcu, M, Dreyer, NA, Franklin, JM, et al. Real-world evidence to support regulatory decision-making for medicines: Considerations for external control arms. Pharmacoepidemiol Drug Saf. 2020; 29: 1228– 1235. https://doi.org/10.1002/pds.4975
Webster-Clark, M, Stürmer, T, Wang, T, et al. Using propensity scores to estimate effects of treatment initiation decisions: State of the science. Statistics in Medicine. 2021; 40: 1718– 1735. https://doi.org/10.1002/sim.8866
Mollie E Wood, Angela Lupattelli, Kristin Palmsten, Gretchen Bandoli, Caroline Hurault-Delarue, Christine Damase-Michel, Christina D Chambers, Hedvig M E Nordeng, Marleen M H J van Gelder, Longitudinal Methods for Modeling Exposures in Pharmacoepidemiologic Studies in Pregnancy, Epidemiologic Reviews, 2021;, mxab002, https://doi.org/10.1093/epirev/mxab002
Lopes, LC, Salas, M, Osorio-de-Castro, CGS, et al. Data sources for drug utilization research in Latin American countries—A cross-national study: DASDUR-LATAM study. Pharmacoepidemiol Drug Saf. 2022; 31( 3): 343- 352. https://doi.org/10.1002/pds.5404
Jodi B. Segal, Ravi Varadhan, Rolf H.H. Groenwold, et al. Assessing Heterogeneity of Treatment Effect in Real-World Data. Ann Intern Med.2023;176:536-544. [Epub 21 March 2023]. doi:10.7326/M22-1510. https://doi.org/10.7326/M22-1510.
Sarri, G., Liu, W., Zabotka, L., Freitag, A., Claire, R., Wangge, G., Elvidge, J., Dawoud, D., Bennett, D., Wen, X., Li, X., Rentsch, C.T., Uddin, M.J., Ali, M.S., Gokhale, M., Déruaz-Luyet, A., Moga, D.C., Guo, J.J., Zullo, A.R., Patorno, E. and Lin, K.J. (2023), Prognostic factors of COVID-19: an umbrella review endorsed by the International Society for Pharmacoepidemiology. Clin Pharmacol Ther. Accepted Author Manuscript. https://doi.org/10.1002/cpt.2977
Endorsed but not yet published:
- Guidance on the Use of Narrative Prescribing Instructions in Pharmacoepidemiology and Drug Utilization Research: A Scoping Review, May 2021
- Validation of algorithms in studies based on routinely collected health data: general principles, August 2021
- Machine learning for improving high-dimensional proxy confounder adjustment in healthcare database studies: an overview of the current literature, endorsed September 21, 2021
- ISPE-endorsed guidance in using electronic health records for comparative effectiveness research in COVID-19: opportunities and trade-offs, endorsed October 28, 2021
- A road map for peer review of real-world evidence studies on safety and effectiveness of treatments, February 28, 2022
- Updated core competencies in pharmacoepidemiology to inform contemporary curricula and training for academia, government, and industry, October 18, 2923
- Contemporary Practice and Considerations for Real-World Data Source Identification and Feasibility Assessment, March 7, 2024
Policies & Statements
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ISPE comments to International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) public consultation on International Harmonisation of Real-World Evidence Terminology and Convergence of General Principles Regarding Planning and Reporting of Studies Using Real-World Data, with a Focus on Effectiveness of Medicines, September 2023
- EuroDURG's Glasgow Declaration: Increasing Access to Drug Utilization Data, endorsed February 2022
- International Network for Epidemiology in Policy (INEP) Position Statement on Conflict-of-Interest and Disclosure in Epidemiology, endorsed November 2020
- Real-world Evidence Studies Require Full Transparency to Ensure Appropriate Interpretation of Results, endorsed July 2020
- ISPE's Position on Real-World Evidence (RWE), endorsed February 2020
- IJPC-SE (International Joint Policy Committees of the Societies of Epidemiology) Policy Brief – Climate Change and Epidemiology, endorsed March 15, 2018
- Declaration of the Health of People, Health of Planet and Our Responsibility Climate Change, Air Pollution and Health Workshop, November 2-4, 2017
- Principles for Effective Academic-Industry Collaboration in Pharmacoepidemiology, endorsed April 1, 2017
- ISPE Statement on ASA Statement on the Misuse of P-values, endorsed April 1, 2017
- ISPE Statement on March for Science, endorsed April 14, 2017
- Evaluating the Effectiveness of additional Risk Minimisation Measures via Surveys in Europe, endorsed November 14, 2016
- Pharmacoepidemiology: Defining the field and its core content; Jones, J.K., Tilson, H.H. and Lewis, J.D. (2012)
- Guidelines for quality conduct in database research in pharmacoepidemiology, endorsed February 28, 2011
- ISPE Statement on the Registration and Public Disclosure of Pharmacoepidemiology Research Protocols, endorsed August 18, 2010
- GRACE Principles (Good ReseArch for Comparative Effectiveness), endorsed April 10, 2010
- Guidelines for Submitting Adverse Event Reports for Publication (published in Pharmacoepidemiology & Drug Safety 2007; 16:581-587)
- Press Release: ISPE Statement on Regulatory Systems to Improve Pharmaceutical Safety, February 22, 2005
- ISPE Statement on Regulatory Systems to Improve Pharmaceutical Safety, accepted by Board February 10, 2005
Good Pharmacoepidemiology Practices
Responses to Public Consultations
- ISPE's official response to the U.S. Food and Drug Administration's (FDA) draft guidance for industry on Benefit-Risk Assessment for New Drug and Biological Products, endorsed November 24, 2021
- ISPE's official response to the FDA's public consultation on the draft guidance for industry on use of electronic health records (EHR) and medical claims to support regulatory decisions on drug and biological products, endorsed November 14, 2021
- ISPE's commentary for submission to PDS, Assessing Feasibility of Using Electronic Health Records and Medical Claims Data for Regulatory Decisions, endorsed November 7, 2021
- ISPE comments to a public consultation of a National Institute of Standards and Technology (NIST) publication, A Proposal for Identifying and Managing Bias in Artificial Intelligence (NIST Special Publication 1270), prepared by ISPE's Real-World Evidence Task Force subgroup, RWE and Real-World Data Sources, endorsed September 3, 2021
- ISPE's comments to the EMA's public consultation on Guideline on good pharmacovigilance practices (GVP): Module XVI - Risk minimisation measures: selection of tools and effectiveness indicators (Rev 3); and Module XVI Addendum II - Methods for effectiveness evaluation, April 2021
- ISPE's comments to the UK's MHRA draft guidance on randomised controlled trials generating real-world evidence to support regulatory decisions, December 2020
- ISPE's comments to a consultation request issued by the International Medical Device Regulators Forum (IMDRF) Medical Devices Clinical Evaluation Working Group on Post-Market Clinical Follow-Up (PMCF) Studies, December 2020
- ISPE President's statement on retraction of Surgisphere-related research papers, June 2020
- ISPE Comments on "Key Considerations in Using Real-World Evidence to Support Drug Development (Draft for Public Review)" by Center for Drug Evaluation, National Medical Product Administration, China, August 2019
- ISPE Comments on FDA Real-World Evidence Program, July 11, 2019
- ISPE's Comments on the Core Recommendations in the Summary of the Heads of Medicines Agencies (HMA) – EMA Joint Big Data Task Force, April 15, 2019
- ISPE BRACE-SIG Comments on FDA’s Public Meeting on the Benefit-Risk Framework, November 17, 2017
- ISPE Response to FDA Questions. Standardization and Evaluation of Risk Evaluation and Mitigation Strategies (REMS) — Public Meeting on July 25-26, 2013, March 5, 2014
- ISPE Statement on American Society of Clinical Oncology’s New Policy for Relationships with Companies, August 24, 2013
- ISPE Comments on Docket Number: HHS-OPHS-2011-0005 Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators, October 20, 2011
- ISPE Comments on U.S. Food & Drug Administration Docket No. FDA 2011-D-0057 Draft Guidance for Industry and FDA Staff on Best Practices for Conducting and Reporting Pharmacoepidemiologic Safety Studies Using Electronic Healthcare Data Sets, April 15, 2011
- ISPE Comments on Approval Pathway for Biosimilar and Interchangeable Biological Products, December 23, 2010
- ISPE Comments on EMA/95098/2010, ENCePP Guide on Methodological Standards in Pharmacoepidemiology, December 23, 2010
- ISPE Comments on European Medicines Agency Road Map to 2015, April 30, 2010
- ISPE Comments on ENCePP Code of Conduct for Independence and Transparency, December 24, 2009
- ISPE Comments on FDA Guidance for Industry Postmarketing Studies and Clinical Trials — Implementation of Section 505 (o) of the Federal Food, Drug, and Cosmetic Act (FDA-Draft - 505(o) - Guidance -7-16-09)
- ISPE Letter to Secretary, US DHHS, Comments on Possible Medicare Part D Public Use and Supplemental Characteristics Files, June 8, 2009
- ISPE Comments on Proposed Part D Public Use Files, submitted to CMS, June 5, 2009
- ISPE Response to U.S. Food and Drug Administration Docket No. FDA-2008-N-0234, Developing Guidance on Conducting Scientifically Sound Pharmacologic Safety Studies Using Large Electronic Data Sets; Public Workshops, June 7, 2008
- ISPE Comments on US Food and Drug Administration Docket No 2007N-0005, Prescription Drug User Fee Act, February 20, 2007
- ISPE Comments on 2006 CIOMS draft "Special Ethical Considerations for Epidemiologic Research" as proposed supplement to the updated 2002 CIOMS International Ethical Guidelines for Biomedical Research Involving Human Subjects, December 12, 2006
- ISPE Response to European Commission Public Consultation: An Assessment of the Community System of Pharmacovigilance, June 29, 2006
- ISPE Response to Statement on JAMA Guidelines for Authors, November 7, 2005
- ISPE Comments on March 2005 draft of the revision of the 1991 CIOMS International Guidelines for Ethical Review of Epidemiologic Studies
- ISPE Comments on EMEA Guideline on Risk Management Systems for Medicinal Products for Human Use, October 4, 2005
- Final ISPE Comments on FDA Draft Guidance for Industry, July 2, 2004
- ISPE Comments on FDA Guidance for Industry Pharmacogenomics Data Submission, February 3, 2004
Other ISPE-Related Documents
