Putting patients first: 5 strategic shifts making clinical trials patient-centric
In clinical research, every day counts, especially for patients awaiting access to potentially life-changing therapies. This creates a meaningful link between every point of clinical trial design and execution and the patient’s needs and potential barriers.
Knowing that meaningful patient engagement leads to better health outcomes, pharmaceutical and biotechnology companies are investing in and gauging patient-centric approaches. But what are these companies doing to put into play the right combinations of services to accelerate trial activities and to address patient recruitment and engagement issues?
From gamified digital platforms to remote sample collection and agile site activation, sponsors are reimagining trial design to meet patients where they are physically, emotionally, and cognitively to improve recruitment and retention and enhance operational efficiency and data quality.
Upping agility in study start-up processes
In today’s fast-paced and competitive R&D environment, accelerating study start-up is a necessity. Delays in trial starts can derail timelines, inflate budgets, and slow patient access to promising therapies.
As part of a multi-pronged approach to proactive study start-up planning, some trial sponsors and clinical research organisations are integrating site networks to anticipate operational needs, adapt to shifting timelines and streamline trial processes. This is especially important in complex trials with challenging protocols.
In practice, this involves standardised turnaround benchmarks, flexible resourcing, and proactive communication among sponsors, sites, CROs, technology providers, etc. To help create predictability and reduce lags, site network management experts can help identify sites able to commit to internal service-level agreements, like feasibility responses within 24 to 48 hours, and include them in trials with aggressive timelines.
With this level of agility and consistency, teams can escalate quickly, flag bottlenecks earlier, and maintain transparency. For sponsors, this translates into faster recruitment and first-patient-in status, improved forecasting and reduced risk of study delays.
Parallel processing
Traditional trial start-up workflows often follow a sequential path, from feasibility to contracting, then regulatory submissions and, eventually, site staff training. This often creates bottlenecks that can delay the first-patient-in milestone by weeks or months and slow treatment access to those in need.
Within any therapeutic focus, parallel processing allows multiple start-up activities to run concurrently, which compresses timelines if quality and compliance standards are not compromised. And the impact on patients is tangible. By initiating contracts, budgets, regulatory submissions, and site training in tandem, sponsors and CROs improve operational efficiency while delivering care without delay.
To fully realise these benefits in real-world settings, stakeholders must align on expectations early in trial planning, use standardised tools and invest in technology that supports concurrent workflows. More than a process shift or upgrade, parallel processing is a strategic commitment that requires clear communication among stakeholders and robust project oversight and tracking.
Game-design elements
Within a broader patient-centric retention strategy, sponsors are integrating intuitive, global technology platforms into trials to help prioritise engagement, collaboration, and transparency,
which patients are demanding. More than just digital interfaces, these platforms are strategically designed to help empower participants with real-time access to their data, personalised support, and clear communication throughout the trial journey.
By enabling collaboration before, during, and after the trial, sponsors are aiming to foster long-term relationships with participants, creating an “alumni” community of sorts that contributes to future trial design and innovation. This approach not only enhances the patient and caregiver experience, but also aligns with regulatory mandates.
The European Union Directive 536/2014 requires sponsors to offer plain language summaries so potential participants can better understand trial information and results. The US Food and Drug Administration has issued guidance outlining how sponsors can collect and submit data on patients’ symptoms and treatment experiences to ensure the patient voice is central to the R&D process and can help shape trial protocols, endpoints, labelling decisions, etc.
Further, “gamification”, the use of game-design elements in non-game contexts, is emerging as a mechanism to watch within the tech platforms for its potential to boost patient motivation and engagement strategies. In the broader healthcare environment, studies show that gamification can help improve users’ health behaviours. With that in mind, sponsors aim to incorporate gaming elements to help transform trial participation into a more rewarding and personalised experience. These elements can tap into intrinsic motivators, like milestone celebrations, recognising purpose of participation, and social connection, to help patients feel more in control and invested in their role within the research and their own care journey. Potential gaming elements can include:
- Core game mechanics, such as awarding “points” for completing trial activities (e.g., surveys, taking medication as required, attending study visits, etc.) or unlocking new levels as patients progress through trial phases.
- Dynamics, like visual trackers to show the participant’s progression through the study timeline or immersive and interactive educational modules that visually explain the study purpose or procedures using plain language, rather than complex medical terminology.
- Aesthetics, such as creating a friendly, consistent theme throughout the experience to make it more engaging or narration framing the trial as a mission to complete. This element also includes visually appealing and intuitive interfaces to increase usability.
- Motivation elements that recognise and celebrate milestones with small incentives (e.g., gift cards or philanthropic donation). Additionally, carefully implemented leaderboards with anonymised rankings among trial participants or site-based challenges, can foster a sense of community and friendly competition, while boosting adherence.
Sponsors can adjust tone and complexity to meet the emotional and cognitive needs of different patient populations. But whether animating interfaces for paediatric trials or using sophisticated dashboards for adults, tailoring these features to specific demographics helps make information and activities relevant and accessible.
It is important to note that gamification is not solely about making trials fun or more interesting for patients. It is about improving outcomes that impact them. Studies show that some gamified components can lead to higher adherence rates, such as compliance rates for daily diary entry completion. These features also help facilitate the collection of high-quality patient-reported outcomes and experience data. For example, playful survey interfaces and challenge-based prompts can encourage timely and accurate data submission, supporting both the FDA and European Medicines Agency’s expectations for robust, patient-centred evidence.
The integration of gamification within compliant, patient-friendly platforms can represent a strategic convergence of innovation and regulation. Sponsors can better meet global transparency standards while creating a more meaningful experience for participants. This approach could be a valuable way to foster long-term relationships with patients, where prioritising their needs can help build trust while allowing for clinical research to reach more patients. As such, it is important for R&D stakeholders to further explore how to evolve gamification as part of broader efforts to strengthen patient engagement in clinical trials.
The human touch
Clinical Trial Educators (CTEs) are emerging as pivotal figures in the shift toward patient-centric clinical research. With backgrounds in nursing, therapy and/or education, these research specialists serve as trusted guides for sites and patients navigating complex trial protocols, especially those with early-stage or asymptomatic conditions, like Alzheimer’s disease. Their ability to assist sites to address emotional concerns and foster trust helps overcome barriers to participation and improve recruitment and retention. For example, these experts can help to ensure trial materials explain complex health information in plain language or determine when translation in materials may benefit communities of interest.
CTEs also strengthen local site operations and community outreach. They engage directly with local patient populations through health fairs and cultural events to raise trial awareness among various racial, ethnic, and socioeconomic groups. Their deep local knowledge enables them to activate referral pathways, collaborate with primary care providers, and identify eligible patients who may not yet be under specialist care. CTEs can also help sites review medical charts and support prescreening efforts.
As clinical trials grow in complexity and scale, the strategic involvement of CTEs helps ensure sites are equipped to support patients with the resources, empathy, and education needed to make research efficient, impactful, and accessible to all.
Redefining sample collection and care
As trial design emphasises accessibility, remote sample collection, as practiced during the COVID-19 pandemic, is emerging as a useful patient-centric approach. It is widely recognised that one of the most significant barriers to trial participation is its travel requirements. Many patients are unwilling to travel for study visits, but many others are unable to, especially when living with a rare disease, cancer, etc. Also, travel adds to the burden of caregivers assisting paediatric patients and those with mobility limitations.
Allowing routine procedures like blood sample collection for lab tests to be conducted in the patients’ homes is helping to reduce participants’ burdens and improve retention, with while improving site adoption and expanding access to participants who would otherwise have been excluded.
Again, having home care and remote collection options helps to humanise trials, is helpful for long-term trials and sustained engagement, and can build trust when there’s continuity among the clinicians who conduct home visits. This can be especially valuable for vulnerable patient populations, such as those with debilitating conditions or high-frequency sampling needs, who may prefer undergoing procedures in private and in the comfort of their home.
Additionally, by decentralising sample collection and care visits, site teams offload these routine tasks and can reallocate resources to complex procedures.
In a new but lasting era of patient centricity
Today, patients are not just participants; instead, they are valued partners in research, and their experience is central to successful drug development. When trial sponsors recognise the shift toward patient-centric trials as a necessity, not a trend, they align trial design and operations with patient needs.
Through innovative, yet tangible approaches that involve fine-tuned tech advances, updates to operational frameworks, humanising the process and more, sponsors are not only improving medical outcomes, but also redefining what it means to participate in clinical research by putting patients first.
About the authors
Sheela Gallardo, MSc, is senior director, medical affairs global delivery head, Clinical Trial Educators, at IQVIA. With more than 25 years of experience in medical marketing, clinical research, and government affairs, Gallardo leads IQVIA’s global Clinical Trial Educator team to drive strategic planning, effective execution, and cross-functional collaboration. As global delivery head, she oversees a therapeutically aligned team of experienced clinicians who partner with sites and sponsors to address recruitment challenges and support robust enrolment and retention across clinical studies. With a deep understanding of the global clinical trial recruitment landscape across many therapeutic areas, she helps to deliver innovative, multidisciplinary solutions that empower sites and sponsors to achieve optimal research outcomes.
Colleen Elizabeth Gosa Nalepinski, MPAS, DMSc, is director of patient and site centric solutions strategy at IQVIA. She is a strategic leader and solutions-driven innovater with deep expertise in clinical research, decentralised trial delivery, and physician assistant education. Her career spans nearly two decades, beginning in Phase I research as a principal investigator and head of medical operations, and with IQVIA, where she specialises in decentralised trials, home visits, and digital patient engagement. Nalepinski is dedicated to driving innovation in patient recruitment, engagement, and retention through technology-enabled strategies.
Jessica Taylor Jones is director, head of digital patient engagement – PRE, for patient and site centric solutions at IQVIA. She is a solutions-oriented innovator with nearly 20 years of combined experience in clinical research and technology development and delivery across pharmaceutical, public health, and academia research sectors. In her current role, she leads a team of innovators focused on delivering custom tech-enabled strategies to help drive successful patient recruitment, engagement, and retention outcomes.
Kimberly Ponder is director of project optimisation at Avacare Clinical Research Network. She brings more than 16 years of experience in clinical research operations to her current role at Avacare, where she leads the internal project management team and guides site activation optimisation across the network. This includes building scalable, agile systems that align with clinical trial sponsor and CRO expectations. Having started her career as a clinical research coordinator, she has deep, hands-on expertise across the full lifecycle of site management, with a focus on accelerating study start-up and driving operational excellence.
