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.

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.

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).

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.

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.

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.

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.

Rivera, DR, Gokhale, MN, Reynolds, MW, et al. Linking electronic health data in pharmacoepidemiology: Appropriateness and feasibility. Pharmacoepidemiol Drug Saf. 2020; 29: 18–29.

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

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.

Bourke, A, Dixon, WG, Roddam, A, et al. Incorporating patient generated health data into pharmacoepidemiological research. Pharmacoepidemiol Drug Saf. 2020; 29: 1540– 1549.

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

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.

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.

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

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.

Real-World Evidence for Assessing Treatment Effectiveness and Safety in Pediatric Populations, Horton, Daniel B. et al. The Journal of Pediatrics,

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).

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.

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.

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.

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.

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,

Endorsed but not yet published (as of August 2021):


Policies & Statements


Good Pharmacoepidemiology Practices


Responses to Public Consultations


Other ISPE-Related Documents