How Should Scientific Focus Change In 2026? Researchers Weigh In

As told to Clinical Leader Executive Editor Abby Proch

A new year is often accompanied by the phrase “out with the old, in with the new,” and the clinical research space is all-in on this sentiment. When asked what should be left behind in 2025, clinical researchers resoundingly pointed to “the old way of doing things.”

Specifically, many are reflectingly critically on the scientific thinking behind drug development and how researchers need to change their approach, whether that’s focusing more attention to cures not treatments or understanding that independent research sites can hang with academic powerhouses.

So Long Single-Agent Therapies?

“A trend that should be retired is the narrow focus on single-agent therapies when combination approaches are proving to be more effective across a range of therapeutic areas. The science has moved on, but clinical development frameworks have been slow to follow. This inertia is compounded by regulatory expectations that continue to favor legacy processes rather than modern data-driven pathways that better reflect today’s evidence-generation capabilities.” — Joel Latham, president and CEO, Incannex Healthcare Inc.

Welcome, N=1 Studies

“We must leave behind the reliance on narrow, homogeneous cohorts and rigid trial structures that no longer reflect the diversity and complexity of the populations we serve. Historically, trials were conducted on small samples of individuals who were relatively similar in age, ethnicity, and health profiles. This approach simplified statistical analysis but fails to capture the rich variety of human biology.

“Today, we have access to advanced tools such as Big Data, AI-driven analytics, wearable devices, and continuous biomarker monitoring. There is no reason to confine ourselves to such restrictive designs any longer. Our population is more varied and physiologically individualized than ever before. Genetics, epigenetics, environmental exposures, microbiomes, metabolic flexibility, and lifestyle patterns differ dramatically among individuals. A therapy that works exceptionally well for one person may yield minimal effects, or even counterproductive results, for another. This isn’t just noise; it’s valuable data.

“This underscores the importance of n=1 studies. They enable us to understand response patterns beyond mere averages and help identify subgroups based on their responses — intense, moderate, or none at all. These studies also allow for tracking adaptation, dose-response relationships, and synergy across multiple treatment modalities.” — Jason Sonners, DC, DIBAK, DCBCN, clinician researcher, University of Miami Department of Molecular Biology

No More Incremental Innovation

“As we head into 2026, it’s time to retire the idea that incremental innovation is enough in clinical research — particularly in areas like ovarian cancer and autoimmune disease, where patients have been underserved for far too long. We’ve spent years talking about repurposed mechanisms, combination tweaks, and marginal gains. But incrementalism hasn’t delivered the breakthroughs patients urgently need.

“We should also leave behind the assumption that patient-specific cell therapies must remain the standard for next-generation treatments. Custom manufacturing adds enormous cost, complexity, and time — barriers that delay care and limit access. Biology is giving us the tools to move past that.

“What we need now is bold, modality-level innovation: scalable, off-the-shelf therapies engineered for consistency, durability, and precise targeting. Synthetic allogeneic iMSCs represent exactly that shift. By using a single donor-derived iPSC line, we can create reproducible, ready-to-use therapies — cells that don’t just circulate systemically but actively home to tumors or inflamed tissue.

“2026 should be the year we stop accepting incremental progress and start demanding therapeutics designed to fundamentally change outcomes. Patients deserve nothing less.” — Sanjeev Luther, CEO, Ernexa Therapeutics

What’s Worse? Innovation For Innovation’s Sake

“Let’s put an end to innovation theater. Policy decisions in 2025 have reshaped clinical research, making this the moment to challenge a dangerous trend — pursuing innovation for its own sake rather than for patient benefit. True progress means measurable gains —greater efficacy, less toxicity, lower cost, and improvements that tangibly enhance daily living. Yet, too often, technology-driven trials proceed without rigorous assessment of incremental patient value. When ‘innovation’ adds complexity or burden, we lose sight of our purpose.

“Aesthetic medicine shows what patient-centric innovation should look like. The rise in demand for less invasive, natural-looking results isn’t just a fad. It’s patients telling us what truly matters to them: minimally invasive technologies that remove excess skin, boost natural collagen, and provide visible, natural results with minimal downtime. Every field should follow this example, asking with each new therapy or device whether we are genuinely serving patients’ goals or just chasing the latest technology.

“As we plan research investments for 2026 and beyond, let’s insist on clear evidence-backed improvements before allocating trial funds. Patient centricity is nonnegotiable. If an innovation cannot demonstrate value over existing options, it shouldn't progress. Otherwise, patients will bear the consequences of our distractions rather than benefit from our discoveries.” — Denise Dajles, CEO, Cytrellis Biosystems

Science Does Happen Outside Academia

“First, we must abandon the idea that meaningful research only happens in academic institutions. Community-based sites consistently deliver high-quality data, reflect the real-world patient population, and often outperform academic centers in both speed and trial execution. Along the same lines, we should drop the assumption that academic centers inherently enroll better. In reality, patients want convenience, familiarity, and access close to home — three advantages community sites provide every day.

“The industry also needs to move past the belief that research is too time-consuming for private practices or that it distracts from scoping or clinic volume. Modern research infrastructure proves the opposite: When properly supported by a research network that strengthens and streamlines key operations, research becomes an efficient, scalable extension of patient care rather than a drain on productivity.

“Finally, we must stop framing clinical research as a passion project or as something that burdens patients. When offered thoughtfully, research expands access to cutting-edge care, reduces financial barriers, and becomes a meaningful, mission-aligned part of a practice’s work.

“If we let go of these outdated narratives, we can move into 2026 with a more inclusive, realistic, and patient-centered understanding of what clinical research should be.” — Jonathan Obert, MD, principal investigator, Gastroenterology Health Partners/One GI

Support Biosimilars

“In 2026, we should evolve our thinking about who benefits from the adoption of biosimilars. It’s still true that the widespread production and adoption of biosimilars represents billions in potential savings for the U.S. healthcare system. But what matters even more is the potential impact biosimilars can have for patients.

“Biosimilars are a key tool for expanding patient access and addressing affordability challenges in the U.S. health care system. Since the first U.S. biosimilar approval in 2015, the FDA has approved more than 75 biosimilars that together have supported more than 460 million incremental days of therapy through competition.

“In recent months, there has been significant momentum with FDA approvals of new biosimilars as well as efforts from the FDA to reduce unnecessary clinical testing and streamline regulatory requirements. The FDA’s guidance removes the requirement for comparative efficacy studies, typically one of the most costly and time-consuming parts of development.

“Historically, the primary takeaway from this would be that streamlined development and regulatory efficiency may encourage more companies to enter the market, increasing competition for key biologics. Just as important, this regulatory change has the potential to meaningfully expand development into therapeutic areas with significant cost barriers and limited options. When more affordable therapies are available, patients may be enabled to better adhere to their treatments and have improved outcomes — the true end goal we share in healthcare.

“As we move into 2026, I hope to see a shift in the conversation around biosimilars toward their potential to contribute to a more sustainable healthcare system by improving patient access and affordability.” — Jon Martin, U.S. commercial lead, biosimilars and established brands, Organon