IQ RWD working group provides industry perspective on clinical pharmacology applications of RWD and RWE in drug development

The International Consortium for Innovation and Quality in Pharmaceutical Development (IQ) real-world data (RWD) working group has published a White Paper, providing industry perspectives on clinical pharmacology applications of RWD and real-world evidence (RWE) in drug development and approval.  

Based on recent publications from member companies in the IQ RWD working group, the article published in the journal Clinical Pharmacology & Therapeutics provides a comprehensive review of present applications of RWD/RWE in clinical pharmacology. Cases using RWD/RWE in various applications are explored including:

• Drug–drug interaction assessments 
• Dose recommendations for patients with organ impairment 
• Pediatric plan development and dosing optimization 
• Model-informed drug development (notably disease progression modeling) 
• Prognostic and predictive biomarker/factor identification 
• Regulatory decision support 
• Synthetic/external control generation for rare diseases 

Alongside randomized controlled trials, RWD/RWE have been instrumental in pharmaceutical innovation and informed decision making across the entire drug-development life cycle. Case examples examined in the article cover both the use of RWE to address clinical pharmacology questions, as well as the application of quantitative clinical pharmacology approaches to analyze RWD, generating RWE. The paper also discusses considerations for selecting common sources of RWD to guide appropriate data selection for clinical pharmacology analysis.  

To achieve broader applications of RWD/RWE, several approaches for adoption by the clinical drug-development industry are suggested: 

• Effective collaboration forming cross-functional teams with various expertise (e.g., epidemiologists, biostatisticians, and clinical scientists) to successfully analyze RWD for evidence and insights generation 
• Development of user-friendly RWD dashboards and interfaces to increase RWD accessibility and usage 
• Inclusion of RWD/RWE at initial stages in clinical pharmacology plans for drug development, with ongoing assessments throughout the process, to maximize the impact 
• Engagement with health authorities and regulators to improve the quality and acceptability of RWD/RWE for new intended labeling claims 

The idea is that with increased understanding and impactful applications of RWD/RWE in clinical pharmacology, the industry can better leverage opportunities for RWE use in addressing key questions pertaining to clinical pharmacology in drug development and regulatory decision making. This publication serves as a key step in these efforts.