Weathering the Shifting Trial Landscape

The clinical trial industry is navigating a period of regulatory uncertainty, geopolitical tension, and potential targeted tariffs. This climate of economic uncertainty is forcing sponsors to reassess their pipelines and scrutinize the efficiency of their R&D investments, while emerging biotechs face a tougher funding environment.

While tariffs and macroeconomic pressures dominate headlines, they’re only part of the story. The broader reality is that trial starts dropped for several quarters before stabilizing again more recently. This change feels structural as much as cyclical, and its ripple effects are being felt across sponsors, CROs, and research sites alike.

Trial starts are stabilizing — and evolving

While new trial starts finally increased again in 2024, the focus of these trials has shifted toward high-impact areas like oncology, rare diseases, and CNS disorders. This reflects prioritization on unmet medical needs and innovation potential. At the same time, interest is moving from small molecules, particularly in late-stage trials, toward biologics and advanced therapies. Emerging biopharma companies now lead much of this innovation, especially in rare disease research, where their trial share has nearly doubled over the past decade.

Interestingly, biopharma funding into Chinese trials, an area of rapid growth in recent years, has dropped dramatically. In 2023, healthcare investment in China fell to $12 billion, down from $31 billion in 2021. Much of this is fueled by global capital flight and regulatory concerns.

In a world where the focus of R&D has quickly changed, the accuracy and timeliness of clinical trials becomes imperative. Sponsors, both large and small, are prioritizing the best candidates in their pipelines for progressing through the trial process and parking the less promising candidates, at least for now.  There is simply no room for delays or overruns for any reason.

De-risking as a differentiator

This new environment creates an imperative to refocus on efficient and agile execution for everyone. Faced with funding cuts to government agencies, regulatory shakeups (such as the FDA’s move to eliminate mandatory animal testing), shifts in global trial geography, and investment prioritization, sponsors are no longer looking for just capacity or scale but also for risk reduction.

How? The answer lies in three pillars.

Operational stability: Staff shortages and burnout are common across sites and CROs, and sponsors increasingly view stability as a proxy for reliability and quality

From a CRO perspective, low project team turnover is increasingly valuable in a talent-constrained world. Every handoff introduces risk: delays, protocol deviations, retraining, and communication breakdowns. A single project manager change can set a trial back weeks. By contrast, consistent teams deliver tighter timelines, better site relationships, and higher data quality.

Sponsors often take notice. Staff continuity is perpetually among one of the top priorities. When clinical programs span years and continents, familiarity matters. Teams that stay together move faster, flag issues earlier, and require less oversight. These are the traits that are what’s needed in a risk-averse environment.

Global flexibility: Multi-region execution capabilities give sponsors contingency planning. If one region becomes politically or economically unstable, trials don’t need to suffer if geographic diversification has already been created.

Beyond just risk mitigation, global diversity also leads to specific competitive advantages. Early-phase trials in Australia, for example, offer low-cost, low-risk entry points, with tax authorities giving significant tax advantages for companies investing in first-in-human insights. Combined with a favorable regulatory environment, this leads to accelerated timelines and reduced investor exposure.

Therapeutic focus: Working with partners who have specialized knowledge in high-priority areas creates executional confidence. For instance, working with therapeutically specialized business partners and CROs ensures that your most important partners understand not just the science, but also the nuances that reduce friction across regulatory, recruitment, and operational milestones.

Defining certainty for the next 3–5 years

There will always be fluctuation in the market, and given the current regulatory and economic uncertainties, no one can afford to wait it out passively. Sponsors that use this period to reassess their trial portfolios, rebalance geographic exposure, and align with CROs who offer real operational stability will be far better positioned when more certainty around tariffs and regulations are reached.

It is imperative to understand which therapeutic areas still attract capital and deprioritize those that are stalled due to market or funding uncertainty. Auditing partnerships for consistency and continuity is also essential as frequent team turnover or vague accountability structures are red flags. Stable, experienced teams not only reduce trial risk but also improve site relationships and data quality.

Finally, this is the moment to build flexible plans. Organizations that develop operational models with built-in scenario planning, ready to scale up or down as the capital environment shifts, will be positioned to take advantage of greater investment when it comes.

In short, the time to position for the next cycle is now. Wait too long, and you may be reacting to change rather than leading through it.

Picture: Gremlin, Getty Images

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