n March 25, the Institute for Clinical and Economic Review (ICER) formally announced the launch of ICER’s Scientific Advice, a new program designed to help sponsors generate clinical trial evidence that supports more comprehensive assessment not only of clinical effectiveness but of value as well.

Sarah Emond (SE): ICER, the Institute for Clinical and Economic Review, was founded with the idea that the US system was making choices about price and access without a lot of transparency into how those decisions were made.

As a group that cares deeply about evidence-driving policy choices, we thought there was an opportunity to bring our independent lens to questions about price and access. This was motivated by the idea that a lot of patients are having trouble with the affordability of the US healthcare system. As an overarching goal, we believe that centering decisions about price and access around evidence will improve access and affordability for patients.

But what’s become apparent to us as we continue our work is how understanding how complicated our drug supply chain is also ends up being a really important piece of information as you think about driving change and about centering patient access in an affordable way using evidence as your guide.

SE: Every review has a component that looks at the cost effectiveness as well as the budget impact. What sometimes ends up happening in conditions that have a lot of patients or a lot of drugs is that we talk more about budget impact than cost effectiveness.

The GLP-1s for obesity are probably the perfect example of this tension. These drugs are wildly cost-effective. Zepbound might even be cost-saving at the prices announced through the Most Favored Nation agreement for expansion into the Medicare and Medicaid population, which we very rarely see.

or more than 25 years, access to new medicines in England and Wales’* National Health Service (NHS) has required a positive recommendation from the National Institute for Health and Care Excellence (NICE). This is based on assessment of clinical and cost effectiveness. To assess cost effectiveness, NICE committees consider both costs and health outcomes, with health outcomes measured in quality-adjusted life years (QALYs).

n clinical trials, outcomes are often clear. In real-world practice, they rarely are.

omen may be represented in clinical drug trials, but they remain invisible in evidence. The gender data gap is real.

s clinical trials become more complex, sponsors are increasingly shifting their performance evaluation criteria from site capacity to predictable performance. For example, multisite clinical networks, offering geographic reach and operational scale, have emerged as a preferred delivery model. However, mere scale (size alone) does not guarantee consistency. Many networks struggle to translate capacity into reliable execution across start-up, enrollment, and data quality. Tufts Center for the Study of Drug Development (CSDD) data indicate that enrollment delays account for ~40% of overall trial timeline overruns, demonstrating that larger site footprints have not translated into more reliable delivery.

rtificial intelligence (AI) and real-world evidence (RWE) are no longer emerging concepts; they are becoming the connective tissue across the entire life-science ecosystem, and they reflect a growing urgency: how do we scale data-driven innovation responsibly while keeping patients, quality, and societal trust at the center?

frica hosts fewer than 2% of global clinical trials despite carrying nearly a quarter of global disease burden. A major driver of this gap is regulatory fragmentation, with more than 40 national regulatory authorities operating at different maturity levels. Multicountry studies often face duplicative reviews, adding 60–90 days even under African Vaccine Regulatory Forum (AVAREF) joint reviews compared with 6–12 months individually.

he Philippines FDA currently manages a regulatory backlog of approximately 18,000 applications (statistics from PFDA), while companies continue to submit new applications.

hat is the European Health Data Space (EHDS) and Why Does It Matter?
The EHDS is a new piece of European law, forming part of a growing regulatory and policy ecosystem for digital and data, including artificial intelligence (AI) (see figure 1 below), and was established in line with the European Commission’s 2020 Strategy for Data. The EHDS ultimately aims to establish a common framework for the use and exchange of electronic health data across the EU and aims to address specific bottlenecks currently observed with data sharing in Europe: the lack of citizen access, power, and rights over their health data; lowered quality of care in primary settings due to the insufficient capacity for sharing and portability of patient data across borders; and the fact that health data is currently trapped in silos across Europe, with various legal and technical challenges prohibiting efficient secondary use.

apan formulated the “Third Term of the Health and Medical Strategy” (hereinafter referred to as the “Third Strategy”), with the approval by the Cabinet in February 2025 based on Article 17 of the Act on Promotion of Healthcare Policy. This overall Strategy aims to consolidate the government’s measures for research and development in the medical field. The Strategy considers current situations such as the decline in Japan’s research capacity and the issues of drug lag and drug loss, and outlines the future direction of research and development, basic policies, and specific measures for the five years from fiscal year 2025 to fiscal year 2029.