Author: [AUTHOR] Published on 3/15/2023 3:43:00 PM

Clinical & Translational Science Real-World Evidence/Real-World Data Special Collection

CALL FOR PAPERS

Clinical and Translational Science (CTS) is inviting submissions for a special collection on Real-World Evidence/Real-World Data (RWE/RWD) that is scheduled for initial, rolling publication in the second half of 2023.

RWD/RWE have been routinely used in epidemiology, clinical practice, and post approval regulatory decisions. This RWE/RWD special collection is built upon the foundation of the ASCPT March 21, 2023 preconference, Advancing the Utilization of Real-World Data (RWD) and Real-World Evidence (RWE) in Clinical Pharmacology and Translational Research, co-sponsored by the IQ Consortium.  The preconference and the special collection aim to advance understanding and application of RWD/RWE.  Selected content from the preconference will be highlighted in the CTS special collection; in addition, new original RWE/RWD articles are welcomed.  
The RWE/RWD special collection will focus on how RWE/RWD can be applied in clinical pharmacology and translational science. Areas of interest include, but are not limited to: 

• Application of RWD and RWE in the scope of clinical pharmacology, translational research, drug development, and regulatory approval 
• Data source, quality, and analytics involved in generation of RWE from RWD
• RWD/RWE applications in informing target product profile: e.g., target indication and target population selection, quantitative criteria for differentiation in efficacy and safety
• Applications in informing biomarker selection
• Applications of RWE to inform Drug Interaction 
• Applications to inform dosing in special populations
• Integration of RWD in disease progression modelling
• Application to support innovative and efficient clinical trial design, e.g., use of external controls from RWD especially in rare diseases, informed priors in Bayesian design
• RWE to support regulatory decision-making and label changes, e.g.., by supplementing Randomized Controlled Trials
• Frameworks for application of RWD and RWE application across clinical pharmacology, translational research, drug development, and approval

Submissions of original research are particularly encouraged, but reviews, position papers, or shorter perspectives are also welcome. Educational, tutorial-style papers, including basics of RWD/RWE will also be considered.  

Please contact ctseditor@ascpt.org for details about manuscript types and format requirements, or review our Author Guidelines here.

To be considered for publication in this high-profile themed issue, manuscripts should be submitted via the online submission and tracking system by September 1, 2023. 

If you would like to make a pre-submission inquiry, please contact the CTS editorial office at ctseditor@ascpt.org.