linical research is undergoing its most significant transformation in decades. Digital health technologies (DHTs), decentralized clinical trials (DCTs), and increasingly complex data ecosystems promise broader access and faster evidence generation. But innovation has outpaced governance.

The greatest risk to decentralized trials is not technological failure; it is architectural fragmentation. Clinical trials are being redesigned faster than the industry’s quality frameworks that underpin them. Without structural alignment between digital innovation and Quality by Design (QbD), decentralization risks weakening the very foundations of safety, accountability, and data integrity it aims to strengthen. This is the hidden governance gap in modern clinical research.

espite decades of guidance encouraging the inclusion of women in clinical research, drug development continues to rely on evidence that is disproportionately generated from male participants. The result is a persistent female data deficit that affects safety, dosing, efficacy, and trust in medicines.

linical trials drive medical innovation and transform patient care—but success often hinges on more than science alone. The movement of drugs, supplies, data, and even people across borders is a puzzle that can determine whether a trial stays on track or stalls. The import, export, and local transit of clinical supplies and study medications are some of the most complex pieces of that puzzle.

hen performing clinical trials in small populations with a limited number of patients available, it is critical from a scientific and ethical perspective that the maximum amount of information is extracted from the available data. Therefore, traditional statistical approaches may not always be the most appropriate or informative.

urning the corner on 2026’s first calendar quarter presents a good opportunity to revisit the top ten, most-read Global Forum articles from 2025. Here’s what you read the most:

The Power of Nonverbal Communication: Saying Everything Without Saying Anything

Cannabis-Derived Drugs in Japan: New Legislation and Outlook

Developing Drugs for Rare Diseases: A New Approach to Generating Clinical Evidence

Artificial Intelligence and Machine Learning in Pharmacovigilance – Unlocking Potential to Drive Innovation in Patient Safety

Invitation to Comment: Warp-Speeding Regulatory Decisions

ur healthcare landscape is rapidly evolving and presenting us with complex challenges: modernizing clinical trials, ethically integrating artificial intelligence, and delivering patient-centric care. No single organization can tackle these issues alone. That’s why industry consortia, such as TransCelerate BioPharma Inc., Clinical Trials Transformation Initiative, and the Innovative Health Initiative, have emerged as powerful engines of innovation and progress, bringing together diverse minds to forge ecosystem solutions.

ith the tremendous development of China’s innovative drug industry as backdrop, 2025 saw the number of new drugs approved by the National Medical Products Administration (NMPA)—the country’s regulatory authority—reach triple digits for the first time, an increase that was driven primarily by therapies developed domestically. The new entrants cover an array of different modalities, therapeutic areas, and developers, showcasing the maturity and increasing diversification of China’s pharmaceutical landscape.

hina’s innovative drug business development (BD) transactions continued gaining momentum throughout 2025, again breaking records across all dimensions for outbound deals. Data from PharmCube’s NextBiopharm® database shows that the total annual transaction value soared from USD 51.9 billion to USD 135.7 billion, while upfront payments reached USD 7.0 billion, and activity jumped from 94 to 157 transactions. These figures reflect the new level of development of China’s pharmaceutical industry as part of the global innovation landscape.

cademic institutions in Japan produce abundant life science research “seeds,” yet many of these seeds never blossom into practical pharmaceuticals for patients (see Cabinet Secretariat Action Plan 2024). This article presents a case study led by the DIA Japan Open Innovation Community (see previous article) that tested this hypothesis: Direct, in-person scientific exchange between academic and industry researchers—within the familiar setting of a corporate research facility—could dismantle communication barriers, foster collaboration, and accelerate the societal implementation of academic discoveries.

igital transformation in regulatory systems is neither a single project nor a final destination. It is an ongoing process that reshapes how information is generated, governed, and used across health systems. Within this evolution, electronic product information (ePI) has emerged as a key enabler to modernize regulatory information governance, strengthen public trust, and improve decision-making throughout the product lifecycle. Now this transformation applies to the pharmaceutical package leaflet.