ecentralized clinical trials (DCTs) have become a cornerstone of modern clinical research, driven by advancements in digital health technologies and artificial intelligence (AI). DCTs have grown rapidly, with a projected market value of $13.3 billion by 2030, growing at a compound annual growth rate (CAGR) of 6.6%. The integration of cutting-edge technologies such as wearable devices and AI-powered analytics has enhanced trial efficiency and patient monitoring. Despite this impressive growth and the sector’s importance in reshaping clinical trial methodologies, DCTs still face significant challenges in implementation, standardization, and global adoption.

magine a physician and a patient sitting quietly together in an examination room. The physician’s eyes are focused on a computer screen as she speaks in brief sentences about elevated A1C levels and the challenges of managing blood sugar through lifestyle changes and medication. The patient nods along silently and anxiously while holding an incomprehensible sheet of lab results and struggling to process her Type 2 diabetes diagnosis.

esmetirom, a novel therapy for metabolic dysfunction-associated steatohepatitis (MASH), the progressive subtype of metabolic dysfunction-associated steatotic liver disease (MASLD), was recently approved by the US Food and Drug Administration (FDA). Blue Cross Blue Shield of America (BCBSA) and other payers subsequently issued approval criteria for resmetirom that include specified thresholds for quantitative results from clinical imaging studies: i.e., magnetic resonance elastography (MRE) and magnetic resonance imaging-based proton density fat fraction (MRI-PDFF). This is one of the first examples where quantitative results from a clinical imaging study (i.e., an imaging assay) are being required to be used as a companion diagnostic.

n 2021, ClinicalTrials.gov listed approximately 350,000 registered trials. That same year, a call to action in The Lancet highlighted the need for collaboration to decarbonize clinical trials and led the Sustainable Healthcare Coalition (SHC) to develop a tool to measure the carbon footprint of clinical trials and highlight hotspots, gauge progress, and benchmark work to reduce associated emissions. Although the tool has been developed, a number of important questions remain about its widespread use and meaningful impact.

ost research sites do not participate in selecting the technology or processes used for clinical trials, as sponsors have traditionally designed protocols and selected tools without investigator feedback. This creates a heavy time and resource burden on site staff managing various systems while working with thousands of patients across hundreds of studies. The impact on site capacity is significant: According to WCG’s 2023 Clinical Research Site Challenges Survey, more than 50% of sites say resourcing issues don’t allow them to open new trials.

f there’s any positive to come out of the COVID pandemic, it might be this: That more and more mainstream humans are aware of clinical research as a care option, that it does not have to be the last option,” suggests Lani Hashimoto (then Associate Director, Patient Engagement Management, Novartis) in this DIA 2024 interview with Deep6 AI CEO and founder Wout Brusselaers. “A patient put that in perspective for me in a powerful way. She said: ‘My first trial was a registry. It was observational. Once I had a relationship with that physician and their staff, then I had confidence to participate in an interventional study.’

he African Union Smart Safety Surveillance (AU-3S) program represents a transformative initiative in strengthening pharmacovigilance (PV) systems across Africa. Designed to address the continent’s unique challenges, this ambitious 10-year program, funded by the Gates Foundation, aims to create a centralized PV infrastructure that enhances confidence in the safety of medical products for African regulators and patients alike.

riven by drugmakers’ growing interest in accessing the world’s second-largest pharmaceutical market, China has recently seen a steady increase in the approval of new drugs—defined as those granted marketing authorization for the first time in the country. In 2024, these newly approved drugs spanned a diverse range of technologies, indications, and origins.

ver the past decade, Europe’s share of global clinical research has declined. Even as the total number of global commercial trials rose by 38%, the European Economic Area share of commercial trials fell from 22% in 2013 to 12% in 2023. This has a real impact on patients: it represents an estimated 60,000 fewer people accessing trials involving an EEA country, and 20,000 fewer places available in EEA-only trials. These latest data, published in October 2024, reflect a long-running trend that must be reversed and illustrate that the European research system is slow and fragmented. Despite these challenges, there is a strong sense that all contributors to EU clinical research are committed to ensuring Europe fully realizes its potential as a great place to conduct trials. These contributors must turn this commitment into measurable results without delay. There has been progress in some areas, mixed with discouraging news on European competitiveness in clinical research.