From insight to impact: Why the patient voice will redefine the future of clinical research for mid-size pharma

The clinical research landscape has undergone a noticeable shift as clinical trial sponsors contend with rising trial complexity, tighter timelines, persistent recruitment challenges, and competition for engagement. Despite these pressures, some solutions have moved from a tactical add on to a comprehensive strategic focus to optimise clinical research: integrating the patient voice into trial design.

But is the shift toward patient-centred trial design making tangible progress toward meeting sponsor goals and improving patient care? Within that, how do mid-size pharmaceutical companies, who face a distinct set of operational and strategic pressures, ensure they address unmet patient needs while also meeting business goals?

In understanding what makes the patient voice so essential to successful drug development, let’s take a critical eye to what is showing to be beneficial, particularly for mid-size pharmaceutical sponsors, and what design and operational staples may further enhance patient-centred trials in 2026 and beyond.

Progress towards a fundamental reshape of trial design approaches

The growing body of data behind this move toward patient-centred trials has become difficult to ignore. Trials that methodically incorporate patient input into study design consistently outperform those that do not. Protocols shaped with patient advisory boards or community insights are experiencing faster start-up timelines, fewer substantial amendments, and improved budget adherence.

In some analyses, cycle times improved by up to 17%, while budget deviations swung from an increase of 3% in traditional trials to a 28% decrease in patient informed ones.

Yet, the most striking observation from recent insight work is how simple gaps in outreach and communication still undermine participation, even among highly engaged patient communities. In a 2025 analysis of cancer survivors, 87% reported they were “never offered” the opportunity to participate in a trial. The barrier was not interest, but awareness.

Also, when patients do hear about trials, real life burdens often overshadow scientific promise. Travel distance, inflexible visit schedules and family care responsibilities are logistical realities that frequently outweigh their concerns about drug safety or side effects. These everyday nuances can stall even the best-designed study.

Sponsors are beginning to confront these barriers more proactively by tapping into platforms capable of capturing real time, real world patient insights. Dynamic online communities, including those like ClinicalResearch.com, are showing to be valuable resources for patients, volunteers, care partners, and healthcare providers who are interested in exploring clinical research as a care option. Through tailored communications, these user-friendly resources aim to encourage engagement and can provide large-scale data that help sponsors better understand patient journeys.

This shift has quietly created a new operational muscle: continuous patient listening, not periodic input.

Mid size pharmaceuticals: Under unique pressure and with unique opportunity

While patient centred design benefits every type of sponsor, its value is particularly pronounced for mid size pharmaceuticals. Unlike large global pharma with diversified pipelines, mid size organisations often have limited assets, narrower therapeutic scope, and fewer internal resources, leaving little room for error across feasibility, recruitment, and timeline management.

For this segment, patient centred design becomes a direct risk mitigation strategy. When one amendment, one feasibility misstep, or one underestimated patient burden can jeopardise a pivotal study and, at times, company viability, integrating real world patient insight early in the design process is a necessity.

The human aspect

While technology enables trial scalability, human expertise is the essential bridge between strategic insight and execution.

Originally conceived as field based recruitment support, Clinical Trial Educators (CTEs) are now strategic partners for sites, especially in complex areas like pulmonary arterial hypertension (PAH). They bring deep therapeutic area knowledge, help identify eligible patients earlier, support protocol adherence, troubleshoot operational bottlenecks, and educate both staff and participants with nuance and empathy.

In global PAH studies, CTE involvement has coincided with accelerated recruitment, sometimes closing months ahead of schedule, alongside higher randomisation rates and measurably reduced screen failure rates.

Their value is amplified for mid size pharmaceuticals, where clinical teams are often lean and multitasking across programmes. Leaders in this segment consistently report challenges such as site staffing shortages, protocol complexity, and inconsistent global readiness, all areas where CTEs’ field based expertise becomes indispensable.

From R&D tactic to strategy: 7 markers of a patient-focused turning point

Looking ahead, 2026 will mark a turning point – a year when patient voice and on the ground human expertise shift from “valuable extras” to core infrastructure in clinical development.

Several markers point toward this shift.

1. Patient voice becomes a regulatory expectation, not a differentiator.

Regulators worldwide have intensified their focus on patient inclusive evidence, and this momentum will only grow. The question is no longer “Did you gather patient insights?”, but “How early, how often, and how meaningfully did they shape the design?”
In 2026, sponsors will face heightened expectations to demonstrate how patient input shaped endpoints, feasibility assumptions, visit schedules, and risks and benefits messaging.

2. The industry moves from episodic patient research to “continuous listening ecosystems”.

In addition to traditional surveys, sponsors will adopt more ongoing pulse checking models. This includes short surveys, digital communities, rapid response listening panels, and more to secure signals earlier and often. This will reduce course corrections during the process and shrink the gap between protocol assumptions and patient realities.

3. Clinical Trial Educators expand into new therapeutic areas.

The success of CTEs in rare and complex diseases will drive adoption in oncology, CNS, metabolic disorders, and other high burden areas. Sponsors will look to CTEs not only to improve recruitment, but also to support protocol comprehension, strengthen trust, and reduce dropout through ongoing education. The CTE model will increasingly blend scientific literacy with empathetic, humanised communication.

4. Trial accessibility becomes a competitive advantage.

With logistical burdens listed as top barriers to participation, sponsors will differentiate themselves through reimbursement clarity, travel solutions, flexible scheduling, decentralised options, and transparent communication. The organisations that translate patient voice insights into operational simplification will optimise potential for trial success.

5. Hybrid roles will define the next evolution of trial support.

2026 will likely see the emergence of roles that blend patient insight analysis, educator expertise, and digital engagement. These hybrid professionals will be able to interpret quantitative patient journey data, synthesise it into actionable site guidance, and facilitate communication directly with study teams. As trial complexity grows, this cross functional skill set will become even more valuable.

6. Messaging strategy will become as important as recruitment strategy.

One of the more subtle predictions involves language. Trials will increasingly compete on clarity, empathy, and trustworthiness in their communications. When informed by real lived experience insights, the right message can unlock participation for historically underserved and underreached communities.

7. Early feasibility will be reimagined through patient insight integration.

Traditional feasibility assessments rely heavily on historical site performance and investigator databases. In 2026, sponsors will augment these with patient derived data on travel constraints, perceived burdens, caregiver dynamics, and willingness to engage. This richer understanding will make feasibility more predictive, potentially expanding accessibility.

Taken together, these predictions point toward a patient inclusive future that is more efficient, predictable, and human.

Patient centred design: A strategic equaliser for mid-size pharmas

For mid size pharmaceutical companies, navigating rapid growth, limited pipelines, and constrained resources, patient centred trial design is emerging as a competitive equaliser.

In 2026, for more predictability and operational stability, these sponsors may lean on:

Patient insight platforms to refine feasibility and reduce amendments.
CTE style roles to supplement lean internal teams.
Patient advocacy partnerships to navigate new regions and more diverse populations.
Hybrid outsourcing models, where CRO partners provide patient engagement strategy and trial design expertise tailored to the sponsor’s maturity.

These approaches also reduce the inherent risk in scaling from Phase II to Phase III studies, a transition mid size leaders regularly describe as one of their most difficult challenges. By partnering with educators and clinical research organisation partners who understand their unique pressures, mid size sponsors can better ensure their innovations reach the patients who need them.

Growing impact of designing with patients, not for them

As clinical research grows more complex and competitive, one lesson from the past year stands out: trials perform better when they are shaped by the people they aim to serve. When lived experience informs scientific ambition, research becomes more effective, resilient, and meaningful.

In 2026, the organisations that excel will be those that treat patient voice not as a box checking exercise, but as an operating principle. Continuous listening, real time adaptation, and human centred delivery will matter as much as scientific rigour. Educators will stand shoulder to shoulder with site teams, and accessibility will be recognised as a core performance driver, not an afterthought.

Ultimately, the shift ahead will be a change in mindset, from designing trials for patients to designing them with patients.

About IQVIA

IQVIA (NYSE:IQV) is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. IQVIA’s portfolio of solutions are powered by IQVIA Connected Intelligence™ to deliver actionable insights and services built on high-quality health data, Healthcare-grade AI®, advanced analytics, the latest technologies and extensive domain expertise. IQVIA is committed to using AI responsibly, with AI-powered capabilities built on best-in-class approaches to privacy, regulatory compliance and patient safety, and delivering AI to the high standards of trust, scalability and precision demanded by the industry. With approximately 88,000 employees in over 100 countries, including experts in healthcare, life sciences, data science, technology and operational excellence, IQVIA is dedicated to accelerating the development and commercialisation of innovative medical treatments to help improve patient outcomes and population health worldwide.

IQVIA is a global leader in protecting individual patient privacy. The company uses a wide variety of privacy-enhancing technologies and safeguards to protect individual privacy while generating and analysing information on a scale that helps healthcare stakeholders identify disease patterns and correlate with the precise treatment path and therapy needed for better outcomes. IQVIA’s insights and execution capabilities help biotech, medical device and pharmaceutical companies, medical researchers, government agencies, payers and other healthcare stakeholders tap into a deeper understanding of diseases, human behaviours and scientific advances, in an effort to advance their path toward cures. To learn more, visit www.iqvia.com.

About the author

Sinéad Callinan, Head of Patient Centered Delivery, IQVIA

Sinéad Callinan is a clinician‑turned–life sciences executive with 20 years of experience leading strategic growth, digital transformation, and operational innovation across global research environments. As head of patient centered delivery at IQVIA, she focuses on expanding access, inclusion, and continuity in clinical research by reimagining how studies meet patients where they are. Callinan brings a unique perspective rooted in her clinical foundation and extensive experience shaping the infrastructure that makes modern clinical research more accessible and effective.

Throughout her career, Callinan has operated at the intersection of people, process, and technology - translating emerging capabilities into scalable delivery models that strengthen site operations, enhance patient engagement, and improve the overall clinical trial experience. She is recognised for her ability to drive complex transformation initiatives, operationalise decentralised and hybrid research approaches, and champion governance models that improve both compliance and the human experience of participating in research.

Passionate about empowering clinical research sites and the patients they serve, Callinan continues to influence how the industry evolves toward more flexible, inclusive, and digitally enabled trial delivery.