2 Expectations & 2 Warnings For The Year Ahead

By Dan Schell, Chief Editor, Clinical Leader

Just when I thought I was done with 2026 predictions for the clinical trial industry, three members of my editorial board emailed me some great ones, hence, part 3 of this series. What’s interesting is that two of these submissions, coincidentally, are focused on optimism for AI. In contrast, Denise Bronner’s forecast for the coming year is much more … well, dire.

Let me know what you think about these predictions or any of the others in part 1 and part 2 of this series. Send me an email at dan.schell@lifescienceconnect.com or message me on LinkedIn, and let’s continue this conversation.

In 2026, the use of AI and digital tools in clinical research will shift from experimentation to large-scale deployment, transforming how studies are designed and executed. By streamlining and automating processes, anticipating bottlenecks, and improving data flow, these technologies will aim to reduce operational challenges for sponsors and sites and enable a robust focus on what matters most — clinical trial participants. This shift will lead to more efficient clinical research, accelerating the delivery of potential new medicines to patients.

• Trial Data Transparency shifts from compliance burden to competitive edge:
  The first sponsor to systematically return meaningful trial data to participants (not marketing summaries, not legal disclaimers) will reset expectations for the entire industry. Patients are no longer passive participants because they expect access to meaningful trial information, clear explanations of outcomes (including failure), and an understanding of how their data contributed to decisions. There is a heightened public skepticism fueled by inconsistent and inflammatory rhetoric from high-profile figures like RFK Jr. Conflicting narratives about science, safety, and “hidden data” are amplifying distrust and leaving patients unsure who to believe. In this environment, silence or minimal disclosure will be interpreted as avoidance.

• Rising Healthcare Costs Will Fracture Trial Participation Into Two Extremes   
  Rising healthcare costs, amplified by recent policy shifts tied to the Big Beautiful Bill and expanded subsidies, will fundamentally reshape who can and cannot participate in clinical trials. Rather than a simple increase or decrease in participation, the system will fracture. For some patients, financial instability, caregiving burdens, and competing survival priorities will suppress interest in research altogether. For others, clinical trials will become a last-resort pathway to care, diagnostics, or novel therapies.

This dynamic will introduce new challenges. Patients seeking trials out of necessity are more likely to present with uncontrolled comorbidities, fragmented care histories, and higher clinical complexity: driving up screen failure rates, protocol deviations, and safety oversight demands. At the same time, the clinical research infrastructure itself will be under strain. Caps on financial assistance for trainees, consolidation driven by private equity, and shrinking academic pipelines will reduce the number of research-ready sites and investigators.

The result is a widening gap between trial ambition and operational reality. In 2026, trial participation will increasingly reflect who has the stability to engage, not who is most affected by disease. This will force sponsors to rethink eligibility criteria, site strategy, and the ethics of access in a cost-constrained healthcare system.

In 2026, pharma will stop experimenting and start choosing who to build/partner with. Sponsors are facing rising costs, crowded pipelines, and an overload of point-solution technology, which is forcing them to shift toward fewer, more strategic partners who can plan and not just place studies with. Multisite Clinical Research Companies are moving AI out of pilot mode and into core site operations, including feasibility, pre-screening, and monitoring. While consolidation accelerates across sites, CROs, and pharma itself, the winners will be the organizations that can reliably deliver speed, quality, and scale across multiple therapeutic areas.