Ben Enejo, partner at Arthur D. Little, argues that the future of clinical development will be defined by the ability to translate scientific innovation into patient impact.
The biggest threat to many clinical trials is no longer science. It is time.
Pharmaceutical companies have long understood the importance of being first to market with new drugs and treatments. According to Arthur D. Little’s analysis of first-in-class oncology assets, first movers can capture up to 60% of market share within a few years of launch. Yet despite the growing importance of speed, clinical trials are, on average, taking longer and becoming increasingly difficult to execute.
This challenge is being driven by multiple forces. Competition for patients is intensifying as more companies pursue the same populations. A wave of patent expirations between 2025 and 2030 is increasing pressure on biopharma companies to replenish pipelines and sustain growth. At the same time, the 2022 US Inflation Reduction Act introduces price controls for small-molecule drugs after nine years on the market, leading to pricing pressure before companies have fully recouped their investment.
Finally, AI-enabled drug discovery companies are shortening development timelines and raising expectations for speed across the industry. The result is a new reality: clinical trial execution has become a strategic differentiator. The organisations that can consistently move promising therapies through development faster and more predictably will be best positioned to create value and deliver innovation to patients.
All of this increases the focus and importance of clinical trial success. Yet, despite the huge level of investment made in the process and its critical impact on revenues, many companies still treat clinical execution as a functional challenge rather than a board-level priority.
Having worked across dozens of global clinical programs, one observation stands out: delays are rarely caused by a single issue. More often, they arise from a series of assumptions that go unchallenged until they become difficult and expensive to address.
What is needed is a more holistic approach that includes better alignment of R&D with enterprise strategy, more strategic use of data and analytics, and more integrated governance. Here are four capabilities of faster clinical development…
Elevate trial speed to board level
Clinical development leaders today must navigate increasing competition for patients, evolving regulations, geopolitical challenges, rising development costs and growing stakeholder expectations. These pressures are making trial speed a strategic issue rather than an operational one. As a result, leading organisations are beginning to elevate clinical trial speed from an operational concern to a board-level priority. This requires greater visibility into execution risks and stronger alignment between r&d, finance and commercial functions. Organisations that treat speed as a strategic capability will be best positioned to accelerate innovation, maximise return on r&d investment and bring new treatments to patients faster.
One example is the appointment of a senior executive accountable for the end-to-end success of pivotal trials. Unlike traditional models, this role combines the authority, visibility, and cross-functional influence needed to rapidly resolve bottlenecks and protect critical timelines.
Design protocols for success
All too often, clinical trial velocity is constrained by protocols that prioritise scientific, regulatory, and statistical requirements at the expense of operational feasibility. For trial speed, the protocol design should be assessed not only for scientific robustness but also for patient burden, investigator and site burden, comparator relevance, endpoint practicality and alignment with evolving standard of care.
Leading organisations are beginning to view protocol design through a broader lens that balances scientific rigour with operational feasibility. This involves assessing protocols against real-world treatment patterns, competing studies, patient preferences, and site capabilities before the first patient is enrolled. In an environment where months can determine market leadership, protocol design should no longer be viewed solely as a scientific exercise but as a strategic lever for accelerating innovation and maximising value.
In our experience, even small reductions in patient burden can have a disproportionate impact on recruitment rates, retention, and overall study timelines.
Pivot from reactive reporting to predictive intelligence
Many clinical trial teams continue to rely on lagging indicators such as monthly recruitment reports, site activation status updates and historical performance metrics to manage trial execution. By the time these indicators reveal a problem, valuable time has often already been lost. In an increasingly competitive environment, sponsors need to move beyond retrospective reporting and adopt predictive intelligence that identifies risks and opportunities before they materialise. This requires integrating diverse data sources such as epidemiology, competing trial activity, referral patterns, patient behaviour, site performance and real-world treatment dynamics to generate forward-looking insights that support faster and better decisions.
This same shift is transforming how leading organisations approach country and site selection, as an example. Historically, site selection has relied heavily on prior relationships, investigator familiarity, and past performance. While these factors remain important, they are no longer sufficient. Today’s sponsors have access to a wealth of external data that can be triangulated to identify the locations most likely to succeed. Competitive trial density, disease prevalence, referral networks, patient sentiment, regulatory timelines, healthcare infrastructure, and site capacity can all be assessed together to create a more accurate picture of recruitment potential.
The value of predictive intelligence is already being demonstrated in practice. In one global Phase III study facing significant recruitment challenges, a predictive monitoring approach combined multiple leading indicators to identify risks months before they appeared in traditional status reports. This enabled targeted interventions, improved visibility across stakeholders, and helped the study recover lost ground and complete recruitment on schedule. The lesson is clear: the future belongs to organisations that can anticipate problems rather than simply report on them.
Underlying each of these capabilities is a common principle: the willingness to challenge assumptions before they become problems.
Challenge assumptions earlier
Many clinical trials are built on assumptions that are rarely challenged until execution problems emerge. Teams assume patient enrolment targets are achievable, sites will perform as expected, and competitors will have limited impact on recruitment. By the time these assumptions prove incorrect, months of valuable time may already have been lost.
The most successful organisations are beginning to apply greater rigour before pivotal studies begin. This includes externally validating enrolment assumptions, assessing protocol competitiveness, evaluating competing studies, and stress-testing execution risks. The objective is not to eliminate uncertainty, but to identify the factors most likely to derail a study and address them before they become costly delays. As with any major investment, stronger decisions begin with a more objective understanding of risk.
Bringing clinical trials into the real world
The future of clinical development will not be defined solely by better science, but by the ability to translate scientific innovation into patient impact faster and more predictably. As competition intensifies and value increasingly concentrates among first movers, trial speed can no longer be viewed as an operational metric delegated to study teams. It must become a strategic capability embedded across governance, protocol design, data-driven decision-making, patient engagement, and execution discipline.
The organisations that succeed in the next decade will not simply discover better medicines. They will develop the capability to move those medicines from concept to patient faster, with greater confidence, and with fewer surprises along the way. In an increasingly competitive healthcare landscape, speed is no longer just an advantage, it is becoming a prerequisite for success.
