Over the past two decades, personalised medicine has moved from scientific ambition to clinical reality. Today, the evolution of personalised therapies has fundamentally changed how the industry thinks about evidence generation and patient inclusion.
Treatments are no longer designed for broad populations; they’re guided by molecular profiles, genetic markers, and increasingly specific disease subtypes. Therefore, precision has replaced population as the measure of progress. This shift has delivered meaningful benefits, improved efficacy, clearer benefit–risk profiles, and, in some cases, transformative outcomes for patients who previously had limited treatment options.
However, personalised medicine has also challenged many of the assumptions that historically underpinned clinical development. Traditional trial models, built around broad inclusion criteria and large, relatively homogeneous populations, are often poorly suited to precision therapies. As a result, operational success in personalised medicine now depends as much on understanding patients and their lived experience as it does on scientific innovation.
Patient-centricity is no longer an optional enhancement to clinical trials. As medicine becomes increasingly personalised, it is now a foundational requirement for feasibility, data quality, and regulatory credibility.
From Scientific Precision to Operational Reality
Personalised medicine is often framed as a scientific exercise driven by algorithms, biomarkers, and genetic profiles. While this level of precision is necessary, it reduces the number of eligible patients and adds complexity to recruitment. These approaches succeed only when they work for patients in real-world settings, where disease burden and treatment decisions are part of everyday life. As inclusion criteria become narrower, traditional recruitment models struggle: screen-failure rates increase, timelines lengthen, and recruitment assumptions are tested by routine clinical practice.
In practice, many precision trials face challenges not due to weak scientific rationale, but because operational planning does not fully reflect real-world patient pathways. Biomarkers may be validated in laboratory settings but are not always tested consistently in routine care. Patients who meet eligibility criteria on paper may encounter practical barriers related to geography, comorbidities, or treatment burden. These gaps contribute to higher screen-failure rates, slower enrolment, and protocol amendments that put pressure on timelines and budgets.
A patient-centric approach helps bridge this gap. This requires an understanding of diagnostic pathways, clinic capacity, travel demands, and health literacy, and how these factors influence participation. The question shifts from whether patients can meet study requirements to whether the trial makes sense within their daily lives.
At the same time, regulators are taking a closer look at who is included in clinical studies and on what basis. Sponsors are expected to show not only that eligibility criteria are scientifically justified, but that they are fair, feasible, and inclusive where appropriate. This is where regulatory expectations begin to intersect with patient experience.
Recruitment: Where Personalisation Begins
Every successful trial starts with a clear understanding of where and how patients can be reached. In precision medicine, this cannot be based on assumptions; it requires evidence. Epidemiological data, biomarker prevalence, and insights from routine clinical practice all play a role in determining whether recruitment targets are achievable.
At Alpha Clinical, recruitment is approached as a core component of early development planning rather than a downstream activity. We work with sponsors to assess feasibility at the level of specific diseases, patient populations, and diagnostic access. By combining feasibility analysis with investigator insight, we help align scientific goals with operational realities.
Recruitment, however, is not driven by data alone. It also relies on trusted relationships with investigators who treat patients regularly and with patients themselves. Clear, respectful communication and patient-facing materials written in plain language, adapted to local cultural and linguistic contexts, support informed participation. This approach fosters engagement well before the first patient is enrolled.
Engagement: Beyond Enrolment
In complex or rare conditions, trial participation often extends over months or years. During this time, study requirements sit alongside everyday responsibilities, symptoms, and uncertainty. Sustaining engagement requires ongoing connection, not just adherence to protocol milestones.
Engagement is supported by clarity. When patients understand the purpose of each visit, test, and follow-up, they are better positioned to remain committed. At Alpha Clinical, we encourage sponsors to approach engagement as a two-way exchange rather than one-way communication. Regular updates, openness about study progress, and clear points of contact help build and maintain trust.
Digital tools can support this process when used with care. eDiaries, tele-visits, and mobile reminders add value when they reduce burden and fit naturally into patients’ lives. When they add complexity or fatigue, they risk undermining participation. Technology should support patients, not demand more from them.
Retention: Designing Trials That Respect Patients’ Lives
Retention is a critical factor in modern clinical trials. While it may draw less attention than enrolment, it has a direct impact on data quality and study outcomes. In precision trials, where participant numbers are often limited, attrition can undermine both scientific validity and programme value.
Effective retention begins at the protocol design stage. Streamlined visit schedules, alignment of study assessments with routine care, and the removal of unnecessary procedures can reduce burden on participants. Hybrid and decentralised approaches offer additional flexibility, such as remote data collection or fewer on-site visits, but must be applied with careful consideration of safety, data quality, and operational feasibility.
Transparency is equally important. When patients understand what participation involves, from follow-up timelines to potential side effects. They are more likely to remain engaged. Strong retention is supported when participants feel informed, respected, and treated as active partners in the study.
Turning Philosophy Into Practice
At Alpha Clinical, patient-centric execution is not treated as a standalone initiative, but as a guiding principle for operational decision-making. By combining real-world data, investigator experience, and patient insight, we develop strategies that reflect how people move through illness and treatment in practice. We view personalised medicine as most effective when trial operations reflect the same focus on individual context.
As clinical research continues to evolve, the question is no longer whether patient-centricity matters, but how early and how deliberately it is embedded into development strategies. In precision medicine, patient-centricity is not an abstract ideal or a regulatory trend; it is a practical requirement for feasibility, credibility, and delivering outcomes that truly matter to patients.
Sophia Nematollahi
