Discussions with sponsors and investigators at ESMO 2026 gave Novotech’s team an opportunity to hear how advances in oncology are influencing study planning and delivery. More precisely defined patient populations, new treatment combinations and development in earlier disease settings are creating opportunities to improve cancer care. Alongside these developments, conversations explored how diagnostic strategies, investigator input and operational planning can support clinical trials.
Reflections from Novotech’s Tanja Obradovic, Romain Pelle, Chris Christodoulou and Yooni Kim show how closely these perspectives are connected. A biomarker strategy influences where a study can recruit. A protocol decision affects whether a site can deliver the study and whether a patient feels able to participate. A global development plan benefits from an early understanding of differences in clinical practice across regions.
The value of considering these questions together, early in development, was a recurring theme in the team’s discussions.
Medical strategy and patient selection
From a medical and scientific perspective, Tanja Obradovic highlights the growing importance of precision patient selection. Molecularly defined populations are increasingly central to oncology development, with implications for when sponsors introduce diagnostic strategies and how they build evidence through successive phases of research.
This requires a clear biological rationale for selecting patients and a plan to test that rationale throughout development. For immunotherapy combinations, understanding the mechanism of action, the population most likely to benefit and the translational evidence needed to interpret outcomes should inform the programme from Phase I. Adding an agent to an established treatment creates a scientific question that the trial must be designed to answer.
Tanja also points to increasing interest in developing therapies in earlier disease settings, including adjuvant and perioperative treatment. These programmes bring different questions about the balance of benefit and risk, the duration of treatment and the evidence needed to demonstrate meaningful patient benefit. They also require careful consideration of endpoints such as disease-free survival and pathological response, alongside longer-term outcomes.
Circulating tumour DNA (ctDNA) and molecular residual disease (MRD) are part of this discussion. Their potential use in identifying patients at higher risk of relapse, informing stratification and assessing molecular response could influence future trial designs. The distinction between identifying risk and predicting treatment benefit remains important, however, and their role needs to be established within the specific disease and treatment setting.
As patient selection becomes more precise, planning for different patient populations and clinical settings becomes increasingly important. Differences in patient populations, diagnostic access and medical practice can affect how findings translate across regions. Tanja’s perspective supports considering international development early, so that the evidence programme can address the populations and clinical settings in which a treatment may eventually be used.
Connecting biomarker strategy with recruitment
These scientific choices also inform operational planning. In his discussions with sponsors and investigators, Chris Christodoulou observed how closely biomarker strategy is now tied to recruitment feasibility.
A well-planned biomarker strategy considers both the scientific basis for patient selection and how eligible patients will be identified within a clinically workable timeframe. Access to next-generation sequencing, the availability of suitable samples, central laboratory turnaround times and referral pathways all influence that process. Each can inform country selection, site readiness and recruitment assumptions.
These discussions highlighted the value of understanding testing pathways during feasibility assessment. Confirming sample requirements, laboratory turnaround times and referral arrangements early can help sites identify eligible patients and support timely enrolment. For sponsors, this provides a stronger basis for recruitment planning than disease prevalence and biomarker frequency alone.
Operational planning therefore needs to examine how patients actually reach a study. Where are they diagnosed? When does testing take place? Who receives the result, and how is the patient referred? Answering these questions early helps connect the scientific eligibility criteria with a realistic route to enrolment.
Investigator input into study design
The investigator perspective reinforces the value of early collaboration. Romain Pelle reports a recurring request from sites at ESMO: involve investigators in protocol discussions before the design is finalised.
Investigators can advise on how study requirements fit into routine practice, assess the available patient population and explain how other trials or treatment options may influence recruitment. Their input can also help teams consider the practical demands on sites and patients alongside the scientific objectives.
In highly competitive indications, including first-line non-small cell lung cancer, some investigators described giving particular consideration to studies of first-in-class or clearly differentiated therapies. Romain also observed strong interest in early-phase research. These discussions underline the importance of understanding both a site’s capabilities and its reasons for committing to a programme.
Protocol complexity was another topic raised in these discussions. Some patients need several conversations with the study team to understand the design, procedures and potential risks and benefits before making a decision. Those conversations are essential to informed participation, but they also prompt a practical question for development teams: which elements of the protocol are necessary, and which could be simplified? Investigators’ experience can also help development teams identify opportunities to simplify procedures and visit schedules while preserving the study’s scientific objectives.
Investigators also raised the importance of crossover options in studies comparing a new treatment with standard of care. Where appropriate, these options may matter to patients considering participation, while requiring careful consideration of the interpretation of overall survival. Such decisions require scientific, statistical and patient considerations to be discussed together.
Supporting sponsors, sites and patients
Yooni’s customer experience perspective brings these issues into the everyday experience of trial delivery. Sponsors, sites and patients have different needs, and a workable programme needs to account for each.
Sponsors need realistic assumptions, clear communication and timely information about study progress and any issues requiring attention. Early assessment of diagnostic infrastructure, access to eligible patients and site capacity can help ensure that plans reflect the conditions in which the study will run.
Sites value practical support that allows them to concentrate on patient care and study delivery. Coordinated systems, clear contracting processes and well-organised biomarker workflows can help site teams manage study requirements. Practical support for pre-screening and testing, clear responsibilities and responsive communication can make participation more manageable.
For patients, particularly those entering studies around surgery or during longer periods of follow-up, participation must fit alongside recovery, family responsibilities and daily life. Accessible information, appropriate flexibility in visit schedules and consistent communication deserve consideration during protocol development. Hybrid or decentralised approaches may help where they are clinically appropriate and suited to the study population.
Regular review of study progress supports this collaboration. Understanding screening outcomes, testing delays, reasons for screen failure and enrolment progress gives teams a stronger basis for deciding where additional support or adjustments may be needed. It also supports informed conversations between sponsors and delivery partners about what is working.
Reflections for development teams
Across the team’s conversations at ESMO, a recurring theme was the value of bringing scientific and practical considerations together early. Patient selection, diagnostic access, protocol requirements and site readiness were closely related parts of these discussions.
For Novotech, these observations reinforce the importance of working closely with sponsors and investigators to understand what each programme needs. Early discussion provides an opportunity to examine recruitment assumptions, incorporate site experience and consider participation from the patient’s perspective.
The team’s experience at ESMO highlighted where this collaboration can be most useful: translating scientific decisions into studies that answer meaningful questions, that sites can deliver and that patients can participate in.