Author: [AUTHOR] Published on 6/20/2024 12:00:00 AM
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CALL FOR PAPERS
Bench to Budget: Streamlining the Full Spectrum of Evidence Integration to Enhance Efficiency and Impact of Drug-Development and Patient Access
The path from drug development to population impact is complex and stakeholders often hold conflicting perspectives. Integration of the foundational but historically disparate disciplines of clinical pharmacology, clinical studies, pharmacoepidemiology, and health economic and outcomes research (HEOR) is critical to producing high-value evidence in an efficient and timely way, as the basis for decision-making by drug developers, regulators, and payers. Clinical Pharmacology and Therapeutics (CPT) is seeking submissions focused on the integration of these disciplines for an upcoming special themed issue “Bench to Budget: Streamlining the Full Spectrum of Evidence Integration to Enhance Efficiency and Impact of Drug-Development and Patient Access” scheduled for publication in April 2025.
The goal of the high-profile CPT “Bench to Budget” special issue is to explore the opportunities and challenges at the intersection of drug development, population health and economic evaluation. The theme is being led by CPT Editor-in-Chief Piet van der Graaf, PharmD, PhD, Certera and Leiden University; CPT Associate Editors Rebecca Miksad, MD, MMS, MPH, Boston University and Miksad MD Consulting, and Spiros Vamvakas, MD, European Medicines Agency; Guest Editor Sebastian Schneeweiss, MD, ScD, Harvard Medical School, and CPT Editors-in-Training Mai Mehanna, PhD, and Ya-Feng (Jay) Wen, PharmD, PhD.
We welcome submissions on a variety of topics, including but not limited to:
- Opportunities and application of integrated evidence generation in fields historically driven by clinical pharmacology, clinical studies, pharmacoepidemiology, or HEOR
- Drug discovery and development, including clinical trial design and analysis
- Payer, health technology access (HTA), and other funding decisions
- Pharmacovigilance and post-marketing surveillance
- Diagnostic and treatment guidelines
- Population health and policy decision-making
- Challenges and considerations for integrating multiple approaches to evidence generation at different points in the drug development to access processes
- Methodology
- Transportability of data from different contexts (e.g., US to EU or Asia)
- Ethics, population representativeness, bias, and equity
- Regulatory, particularly impact on labeling
- Future directions for integrating the full spectrum of evidence generation from early drug development to population health
- Artificial intelligence and machine learning to improve evidence generation
- Precision medicine
We strongly encourage the submission of original research; reviews, position/white papers or shorter perspectives are also welcome. Educational, tutorial-style papers will be considered. In the cover letter of your submission, please state that you are responding to the Bench to Budget Call for Papers.
To be considered for publication in this themed issue, manuscripts should be submitted via the online submission and tracking system no later than September 30, 2024.
Please contact cpteditor@ascpt.org for details about manuscript types and format requirements, or review our Author Guidelines here. If you would like to make a pre-submission inquiry, please contact the CPT editorial office at cpteditor@ascpt.org.
