
- FEATURE ARTICLES
- Breaking Financial Barriers: Making the Shift to Reasonable Compensation for Clinical Trial Participants
- Data Quality Assessment for EU Regulatory Decision-Making
EFPIA’s Perspective on Implementing EMA’s Data Quality Framework (DQF)
- Implementation of Critical to Quality Factors (CtQ) in a Clinical Trial
- A Continuously Learning Ecosystem: How AI Unlocks Hidden Stories in Millions of Patient Data Points
- Keys to Unlocking Regulatory Excellence
New eBook Explores and Explains the Value of Regulatory Information Management
- SPECIAL SECTION: REPRESENTATIVE CLINICAL TRIALS
- Clinical Trial Representation: Progress or the Muddy Middle?
- DEI Fatigue Misses the Point
- How to Address Misalignment in Clinical Trial Representation
- Barriers to Stakeholder Collaboration
- Operational Changes Necessary to Ensure Representative Clinical Trials
- MEETING HIGHLIGHTS: DIA India Annual Meeting
- Bridging Tradition with Modern Safety Standards: Exploring the Pharmacovigilance of Ayurveda and Unani Medicines
- AROUND THE GLOBE
- Local Manufacturing of Medical Products in Africa
Pipe Dream or Realistic Aspiration?
- European Medicines Agencies Network Strategy (EMANS) to 2028: Q&A with EMA and INFARMED
Interview with Melanie Carr (Head of Stakeholders and Communication Division, EMA) and Rui Santos Ivo (President, INFARMED & Member of HMA Management Group)
- The Evolving Regulatory Framework in India: Impact on the Pharmaceutical Industry
- WHITE PAPERS
- Dimensions-Digital Science: Navigating the AI Landscape: Understanding Trends, Jargon, and Data Readiness
- Think Company: Building a Successful Omnichannel Digital Strategy for HCPs
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Editorial Board
Content stream editors
Gary Kelloff US National Institutes of Health
Ilan Kirsch Adaptive Biotechnologies Corp.
regulatory science
Isaac Rodriguez-Chavez 4Biosolutions Consulting
Patient engagement
Natasha Ratcliffe Patient Engagement Specialist
Thomas Smith Independent Patient Consultant
Data and Digital
Lisa Barbadora Barbadora Ink
VALUE AND ACCESS
Wyatt Gotbetter Parexel
Editorial Staff
Sandra Blumenrath, Senior Scientific Project Manager & Executive Editor, Scientific Publications DIA Scientific Communications
Chris M. Slawecki, Managing Editor, Global Forum DIA Scientific Communications
Linda Felaco, Copy Editor and Proofreader
Regional Editors
David Mukanga Bill and Melinda Gates Foundation
ASEAN
Jin Shun Belief BioMed
AUSTRALIA/NEW ZEALAND
Richard Day University of New South Wales, Medicine, St. Vincent’s Hospital
CHINA
Ling Su Shenyang Pharmaceutical University, Lilly Asia Ventures
EUROPE
Emma Du Four Independent R&D/Regulatory Policy Professional
EUROPE
Isabelle Stoeckert Bayer AG Pharma
INDIA
J. Vijay Venkatraman Oviya MedSafe
JAPAN
Toshiyoshi Tominaga Keio University Hospital, Clinical and Translational Research Center
LATIN AMERICA
Cammilla Gomes Roche
US
Ebony Dashiell-Aje BioMarin
DIA Membership
Bringing together stakeholders for the betterment of global health care.
Clinical Operations Specialized Consultant
WCG
Equipoise Consulting, LLC
DIA
Mural Health
linical trials play a crucial role in bringing new therapies to market. However, participation rates in many trials remain alarmingly low, particularly among underrepresented groups, despite numerous initiatives designed to address this challenge. A significant barrier is the financial burden placed on participants. The absence of sufficient financial support is overwhelmingly a factor that limits participation in clinical trials, especially those from lower-income backgrounds*.
Janssen Research and Development, LLC, A Johnson and Johnson Company
Merck Healthcare KGaA
Merck & Co., Inc.
Novartis
Biogen
BMS
BMS
Astellas
Novartis
eal-world evidence (RWE) can potentially complement clinical trials and support regulatory decision-making, but only if underlying real-world data (RWD) are sufficiently relevant and reliable and if quality measures are applied during collection, handling, and processing. Regulators and other stakeholders would benefit from alignment of frameworks for evaluating RWD quality. As a first step towards this, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a Data Quality Framework (DQF) in October 2023, with a real-world evidence DQF annex expected in 2024. In response, the European Federation of Pharmaceutical Industries and Associations (EFPIA) sought to assess available tools for implementing the DQF, with the goal of trying to operationalize the framework and informing future efforts. EFPIA’s findings and recommendations were presented and discussed with EMA in May 2024 and are illustrated in this article.
Daiichi Sankyo
Genentech, Inc.
ritical to Quality (CtQ) factors, cited and explained in ICH E8 (R1), are designed to confirm that a clinical study is designed to answer the research questions and to focus on monitoring variables that matter. Application of CtQ factors, as part of Quality by Design, can eliminate nonessential activities and data collection from the study. This streamlined approach, from application of CtQ factors within the Common Technical Document (CTD) dossier, can assist Health Authorities with their review of a product application. However, during an interactive Content Hub at the DIA Global Annual Meeting 2024, the DIA Good Clinical Practice & Quality Assurance Community attendee survey revealed that only 10 of approximately 150 attendees (6.7%) stated that their company used CtQ factors.
PicnicHealth
VB Insights, LLC
FTI Consulting
he new eBook Achieving Excellence in Regulatory Information Management compiles industry knowledge and experience representing the spectrum of Regulatory Information Management (RIM) capabilities. For mature regulatory teams, the eBook provides best practices across the capability areas. For a young company investing in RIM for the first time or bringing its first product to market, there’s no better way to get educated on the scope of RIM processes, data, and documentation and how RIM capabilities leverage these assets. The eBook also gives an idea of the scale and magnitude of what is required to effectively implement a regulatory information management solution, including cross-functional interfaces.
White Paper
White Paper
Salem Oaks Consulting
Rare New England
VCahee Consulting LLC
Clinical Trials Transformation Initiative (CTTI)
AnthroSci LLC
Inspired Health Strategies, LLC
linical trials do not yet adequately reflect the populations who use the drugs once they are approved. This article introduces four challenges that could slow down progress in clinical trial representation.
- Collection of Race and Ethnicity Data in Clinical Trials (October 2016)
- Evaluation and Reporting of Age-, Race-, and Ethnicity-Specific Data in Medical Device Clinical Studies (September 2017)
- Enhancing the Diversity of Clinical Trial Populations — Eligibility Criteria, Enrollment Practices, and Trial Designs (November 2020).
AnthroSci LLC
VCahee Consulting LLC
Salem Oaks Consulting
Rare New England
Clinical Trials Transformation Initiative (CTTI)
Inspired Health Strategies, LLC
ealth disparities exist across racial and ethnic groups, income levels, and geographies. Recent heightened awareness of inequities in quality healthcare sparked a renewed social justice movement. DEI (diversity, equity, and inclusion) appears to be taken more seriously not only in healthcare, but across industries. It was in this charged environment that the US FDA released its final guidance on Enhancing the Diversity of Clinical Trial Populations in 2020 and updated Diversity Action Plan (DAP) draft guidance in 2024.
VCahee Consulting LLC
Salem Oaks Consulting
Rare New England
Clinical Trials Transformation Initiative (CTTI)
AnthroSci LLC
Inspired Health Strategies, LLC
isalignment on diversity in clinical trials continues. Some sponsors have proactively implemented Diversity Action Plans for their clinical programs ahead of FDA requirements, for example, while other sponsors choose to wait until firm requirements are in place. Even during implementation, some team members find diversity or representation critical; some don’t find it necessary; still others consider diversity a nice gesture but don’t prioritize it.
VCahee Consulting LLC
Salem Oaks Consulting
Rare New England
Clinical Trials Transformation Initiative (CTTI)
AnthroSci LLC
Inspired Health Strategies, LLC
onversations about including diverse populations in clinical trials have been ongoing for decades. It has been well established that trial representation should reflect the population of those affected with the disease or condition.
Inspired Health Strategies, LLC
VCahee Consulting LLC
Clinical Trials Transformation Initiative (CTTI)
Salem Oaks Consulting
Rare New England
AnthroSci LLC
t is a fundamental principle of drug development for sponsors to understand who is likely to use their product to manage their disease or condition. To ensure that clinical trials accurately represent the population who will potentially use the products once approved, we have to change how we work.
White Paper
White Paper
Himalaya Wellness Company
Jawaharlal Nehru Medical College
Aligarh Muslim University
Oviya MedSafe
he integration of pharmacovigilance (PV) with traditional medicine systems is an important yet underexplored area. As regulatory science, pharmacovigilance has grown considerably in the past two decades, predominantly focusing on modern medicinal products. However, the world of Alternative Medicine—comprising Ayurveda, Yoga, Unani, Siddha, and Homeopathy (AYUSH)—offers a vast array of health solutions that are used by millions globally. Despite their popularity, these systems have not yet been subject to the same level of scrutiny from a safety and efficacy standpoint as modern pharmaceuticals.
Bayer Pharmaceuticals
ecent pandemics have triggered calls for deglobalization in the production of medical products to ensure that these products are manufactured closer to those who need them.
he draft European Medicines Agencies Network Strategy EMANS to 2028 has recently been through a public consultation and is expected to be finalized in March 2025, with a workshop with stakeholders planned for February 2025.

Head of Stakeholders and Communication Division, EMA

President, INFARMED
Member of HMA Management Group
Takeda
ince 2001, the regulatory environment for clinical research and drug development in India has undergone a substantial transformation. Key regulatory changes have significantly impacted the pharmaceutical industry and led to ongoing and upcoming regulatory developments in India. These industries will need to adapt to this new environment to remain competitive on the local and international markets.

