strategic initiatives

ISPE-Funded Manuscripts Initiative

ISPE annually funds proposals for manuscripts that could be used for guideline development, or reference documents for pharmacoepidemiology, including pharmacovigilance, drug utilization research, outcomes research, comparative effectiveness research, and therapeutic risk management.


Suggested topics of interest to the Society include:

  • COVID-19
  • Real-world evidence
  • Precision medicine
  • Patient-generated health data
  • Signal detection in emerging large data sets such as EHR or social media
  • Use of pharmacological / mechanistic data in pharmacoepidemiologic studies
  • AI and machine learning approaches vs. classical PE to examine causal hypotheses
  • New methods in pharmacoepidemiology
  • Best practices related to specific approaches in pharmacoepidemiology
  • Formal evaluation of risk mitigation approaches
  • Measuring the impact of pharmacovigilance activities
  • Guidance/methods (design/analysis) of multi-database studies
  • Any topic contributing to ISPE’s strategic mission


Proposal are assessed against the following criteria:

  • Appropriateness of issue to the general ISPE membership
  • General interest of topic to ISPE membership
  • Feasibility to accomplish the stated objectives
  • Importance (or significance) of proposal to the field of pharmacoepidemiology
  • Visibility (the extent to which the proposed manuscript will be used and, if so, raise the visibility of pharmacoepidemiology)
  • Collaboration among multiple organizations, work sectors, and geographic regions, and
  • Consistency with ISPE strategic goals, objectives and priorities

Manuscript funding averaged USD 7800.00 for the seven accepted in 2019. As the total number of manuscripts funded is governed by the budget allocated by the Board, actual funding changes each year.

Proposals must conform to the format described in this document.

The submission process for 2020 has now closed and further submissions are no longer being accepted. If you missed this year's program, please consider applying next year.


General Timeline

Sep 28 – submission deadline

Oct 31 – Strategic Planning Committee completes first review

Nov 30 – author responses to SPC feedback due

Dec 31 – SPC makes final selections; notifications to lead contacts


Manuscript Proposals Previously Accepted

  • Guidance for the identification, collection and reporting of data source heterogeneity in multi-database pharmacoepidemiologic studies
  • Guidance for use of an external control group for uncontrolled long-term extensions of clinical trials
  • Guidance on use of quantitative bias analysis to evaluate quality of evidence in RWD external comparator studies
  • Using electronic health records for comparative effectiveness research in patients with coronavirus disease 2019: opportunities and trade-offs
  • Using manuscript retractions to inform real-world data (RWD) quality and reporting standards
  • Formal evaluation of risk mitigation/minimization measures for regulatory assessment: Recommendations for future approaches using the RIsk Minimization Evaluation Checklist (RIMEC)
  • Guidance on the Use of Narrative Prescribing Instructions in Pharmacoepidemiology and Drug Utilization Research: A Scoping Review
  • Guidelines and Best Practices for Evaluating the Causal Effects of Medications on Motor Vehicle Crashes and Driving Outcomes using Observational Data
  • Handling bias and confounding: High-dimensional propensity score (HDPS) for empirical covariate selection in secondary database studies
  • Pharmacoepidemiology: Core Competencies and Curricula for Academia, Government and Industry
  • Visualization in pharmacoepidemiology to design and communicate secondary database studies
  • Machine learning for improving high-dimensional proxy confounder adjustment in healthcare database studies: a review of the current literature


  • Propensity Scores in Real World Evidence.
  • Guidelines for Best Practices in Validation Studies in Pharmacoepidemiologic Studies that Use Routinely Collected Data.
  • Guidance for the Application of Longitudinal Methods for Exposure Profiling in Pharmacoepidemiologic Studies in Pregnancy.
  • Developing a Framework for Combining Randomized Controlled Trial and Non-Randomized Data in Evidence Synthesis for Informed Health Care Decision Making.
  • Observational External Comparator Cohorts as Controls for Long-Term Uncontrolled Extensions to Randomized Clinical Trial.


  • Quantifying the impact of outcome misclassification on the results of pharmacoepidemiology database studies (Database SIG)
  • Digital Patient Generated Data (Digital Epi SIG)
  • Developing a set of best-practice standards for the communication of risk in pharmacoepidemiological research
  • Publicly Available Data Sources for Drug Utilization Research in Latin American (LatAm) countries (LA-DURG).
  • Requirements for Conducting Multi-Country Safety Surveillance of Vaccines in the Asia-Pacific region (AsPEN SIG)
  • Guidance for the Application of Pharmacoepidemiological Research and Methods to Best Inform Therapeutic Decision Making for Off-Label Medicines Use


  • Importance of Pharmacoepidemiology for Advancing Precision Medicine
  • Guidance for the Application and Reporting of Self-Controlled Study Designs in Pharmacoepidemiology
  • Reporting of Pharmacoepidemiology Research Using Routinely Collected Real-World Evidence
  • Good Practices of Drug Utilization Studies in Countries from Latin America and African Regions
  • Linking Electronic Health Data in Pharmacoepidemiology.


  • ISPE Best Practices on the Conduct of Active Surveillance in Resource-Limited Countries
  • Good Practice Guidelines for Conducting and Reviewing Cross-National Drug Utilization Studies
  • Patient Engagement in Observational Pharmacoepidemiology Research and Registries: Where Are We, Where Do We Need to Be, And What Are the Steps for Getting There?


  • Managing Change for Good Pharmacoepidemiology Practice in Healthcare Databases and Related Tools (Published Bourke A, Bate A, Sauer B C, Brown J S, & Hall G C, Evidence generation from healthcare databases: recommendations for managing change. Pharmacoepidemiol Drug Saf, 25: 749–754. doi: 10.1002/pds.4004. 2016)
  • Importance of Feasibility Assessments Before Implementing Non-Interventional Pharmacoepidemiologic Studies of Vaccines: Lessons Learned and Recommendations For Future Studies (Published Pharmacoepidemiol Drug Saf. 2016 Dec;25(12):1397-1406. doi: 10.1002/pds.4081. Epub 2016 Sep 7.)