Authors
- Kieran Davey – Senior Global Medical Affairs Leader, AstraZeneca
- Maureen Lloyd – Executive Director, LLOYDMJMC LLC
- Alka Shaunik – Global Head Evidence Generation, CSL
- Cerise James – Principal, Tilghman James Group LLC
- Clare Jackson – Independent consultant
A position paper by the MAPS Medical Communications Focus Area Working Group
Disclaimer: This paper represents the opinions of the authors and not those of their organizations
About this Position Paper
The insights within this paper are distilled from over 40 years of combined Medical Affairs experience and comes to you from our experts within the MAPS Evidence Generation domain.
Key learnings:
- How competitive levels of evidence, particularly real-world evidence, are increasingly important for therapeutic success
- The value that NCSR can bring to an integrated evidence generation plan throughout the product lifecycle
- Definitions and types of NCSR, including IIR and collaborative research, and when to use each one
- Key considerations to ensure NCSR delivers strategic value
- The importance of early risk mitigation through detailed contracts, processes, and agreements
- Important compliance and legal considerations for each type of NCSR
- Challenges and best practices for NCSR
- How to steer NCSR studies towards timely execution and lower risk
1.0 Executive Summary
Medical Affairs collaborates across functions to deliver integrated evidence generation plans and, ultimately, timely and relevant evidence that supports informed decision-making throughout the product lifecycle. While company-sponsored randomized controlled trials remain the foundation of regulatory submissions and are critical for informing clinical practice, they often raise further questions from a variety of stakeholders. Regulators, clinicians, payers, policymakers, patients, guideline societies, and patient advocacy organizations may require additional evidence beyond that provided by company-sponsored trials.
As the demand for increased levels of evidence grows, so too has the role of Non- Company Sponsored Research (NCSR)— in which a pharmaceutical company partners with an external organization or investigator who acts as the regulatory sponsor. NCSR encompasses Externally Sponsored Collaborative Research (Collaborative Research) and Investigator- Initiated Research (IIR) and has become well-established as a strategic asset in integrated evidence generation.
NCSR is positioned to address novel mechanistic and clinically relevant questions that inform decision-making, policy, and company strategy. These studies can generate data for patient populations that are underrepresented or excluded from pivotal trials, explore novel treatment combinations based on emerging data
more quickly than large trials, provide answers to practical questions encountered in clinical practice, and examine outcomes across geographically representative and diverse patient groups. Often, this is achieved through the generation of real-world evidence (RWE) in routine care settings.
This position paper provides a practical overview of how Medical Affairs teams can better leverage NCSR to address evolving stakeholder evidence needs. It outlines the different types of NCSR and explores how integrated evidence generation planning ensures alignment across functions.
When planned in coordination with broader evidence strategies, NCSR can be used strategically to fill evidence gaps, extend scientific knowledge, map product utility, understand patient experiences, and explore potential new indications. Key considerations are discussed—including strategic alignment, compliance and legal, and operational best practices— alongside common challenges and solutions gathered from MAPS subject matter experts within the Evidence Generation domain.
