Real World Evidence (RWE): Paths to Enhancing Patient Access to New Medications

There is now global availability of robust and privacy protected electronic health records, as well as great advances in methodologies to collect, analyze and convert real world individual-level patient data into high quality effectiveness and safety information, especially in patient populations where conduct of gold-standard randomized controlled studies is challenging or overly time-consuming. In this context, why does real world evidence (RWE) generate from real world data (RWD) still face challenges in terms of helping patients with life-threatening diseases to access novel medications?

The goal of this special edition is to collect a series of high-quality, peer-reviewed manuscripts focusing on:

1) Challenges still existing in 2023 among regulatory and health technology agencies in accepting RWE as the formal and official evidence for regulatory and reimbursement decisions;
2) Advances in study design, data collection, data synthesis and novel methodologies to mitigate limitations inherent in engaging real world data; and
3) Moving towards the development of harmonized templates (eg HARPER) for the generation and reporting of RWE with eventual incorporation of RWE into modules of the Common Technical Document (CTD) for global regulatory submissions and approvals.

The editors aim for this Special Issue of the Journal of Pharmacy and Pharmaceutical Sciences to form a handbook of useful information for epidemiologists, other health researchers, health economists and regulators in the field of RWE to continue to overcome challenges facing the use of real world data to advance patient care.

For authors, please also review the journal's information regarding Author Guidelines and Article Processing Charges, or direct any questions to the Editorial Office.

Abstract Deadline: 1 May 2023
Manuscript deadline: 1 November 2023