What Sponsors Get Wrong When Initiating an Oncology Study
How CRO selection significantly influences study outcomes
By Luke Gill and Claudio Hegenberger, M.D.
A groundbreaking oncology protocol only delivers if the team can navigate a crowded, chaotic trial landscape and generate reliable clinical data. While novel science gets the headlines, and pending regulatory agency dossier takes immediate priority as focused milestone, the success of a trial is dictated by therapeutic area focus and the deep, indication-level fluency required to both find right patient population and to manage evolving standards of care.
Oncology trials are not simply more complex versions of other studies. Targeted therapies with biomarker-driven development is only one reason. A target population may look viable on paper, but that says very little about the number of reachable patients in the real world. In addition to disease incidence, sponsors must also account for geographical diverse biomarker prevalence, testing rates, tissue availability, referral pathways, diagnostic turnaround times, and the density of competing trials targeting the same population.
This reality exposes weaknesses in traditional feasibility models. Historical enrollment performance often receives too much weight, while diagnostic pathways, real world testing behavior, and competing trial density are underestimated. A protocol that appears feasible during planning can struggle once it meets the realities of fragmented testing infrastructure and uneven access to the right patient populations.
Competition compounds the problem because when multiple studies pursue the same treatment paradigm, bifurcated by molecular target or biomarker defined subgroup, the margin for error compresses substantially. And this narrow patient population increases the consequences of small mistakes. Sponsors simply cannot afford to lose time due to small inclusion criteria mistakes, preventable startup delays, or a poor regional strategy.
In our experience supporting and leading oncology studies at both sponsors and CROs, we have personally seen that choosing the right CRO partner with real indication-level experience is one of the earliest and most consequential decisions a sponsor makes. This is because selecting a CRO based on their overall volume of trials instead of focus, speed and value will often turn promising science into delays, amendments, and missed milestones.
Where oncology expertise actually changes outcomes
What should sponsors look for when searching for a partner? Simply saying they want an oncology-experienced CRO is too vague to be useful. The better question might be to understand where, specifically, oncology fluency improves operational execution. A few specific areas very quickly reveal whether that expertise is real.
Protocol design: One important area is protocol design, particularly inclusion and exclusion criteria. Criteria that appear scientifically rigorous can be difficult to operationalize in real world clinical settings. They may not align with how patients present in clinic, how biomarkers are tested locally, or how treatment pathways actually unfold. Teams with deep oncology experience are often better positioned to challenge unrealistic assumptions early and distinguish between scientific idealism and operational feasibility.
Country / Site selection: Another common fault line is whether you’re actively de-risking regulatory and enrollment risk, or defaulting to familiar countries and sites. Sponsors often gravitate toward either their personal historical experience or some prestigious academic centers with strong reputations in oncology research. While these institutions can play an important scientific role, reputation alone does not guarantee consistent enrollment performance.
The countries and sites that enroll effectively are often those with access to the relevant molecular patient population, strong referral networks, and experienced study coordinators who can identify and move eligible patients through screening efficiently. Therefore, the question is not simply whether a site conducts cancer research but whether that site sees the specific patients the study requires.
Patient retention: operational execution also extends to patient retention. Oncology trials frequently impose significant logistical demands on participants, including repeated imaging, frequent visits, and complex monitoring schedules. Patients who qualify for a study may still withdraw if travel burdens, scheduling challenges, or communication breakdowns make participation difficult. Maintaining engagement often depends on site staff experience and the ability to manage the patient journey effectively.
Strategic guidance: oncology expertise also helps teams anticipate problems before they become amendments. Many protocol amendments arise from operational blind spots that could have been identified earlier, such as unrealistic screening assumptions, imaging logistics, or workflow friction at participating sites. When these issues surface after the trial has begun, they can trigger delays, increase costs, and reduce access to already limited patient pools.
Safety monitoring and endpoint execution: the same principle applies to safety monitoring and endpoint execution. Oncology trials often involve complex toxicity profiles, dense assessment schedules, and coordination between multiple clinical specialties. These factors influence how studies must be staffed, monitored, and supported from the beginning. They are not operational details to resolve after the trial starts.
Collectively, these operational realities are not nearly as sexy as the novel science behind the study, but they can determine whether a study meets its enrollment and data quality goals.
Our recommendation: what sponsors should actually probe in a CRO
The mistake sponsors sometimes make is assuming that oncology capability is easy to recognize. Large teams, polished proposals, and broad therapeutic coverage can create the appearance of strength without demonstrating the specific type of expertise that matters once a study is underway. In rapidly evolving therapeutic areas, the relevant knowledge often lies in teams that understand the current treatment landscape and modalities, diagnostic environment, and competitive trial activity in specific tumor types.
Sponsors evaluating CRO partners should look beyond general oncology claims and focus on several practical questions.
1. Depth in the specific scientific expertise with specific indications.
Oncology experience is not interchangeable across tumor types. Operational realities differ significantly between disease settings, lines of therapy, and biomarker strategies. Teams that understand the nuances of a particular indication are better equipped to anticipate feasibility challenges and enrollment risks.
2. Experience with biomarker stratified and adaptive trial designs.
Precision oncology has made diagnostic infrastructure a central operational variable. CRO teams should be able to discuss how testing pathways, pathology workflows, specimen handling, and turnaround times influence enrollment feasibility across regions.
3. The relevance of the investigator network.
Having relationships with oncology investigators is valuable, but the critical question is whether those relationships provide access to the specific patient subpopulation required for the study. If a protocol depends on a narrowly defined molecular segment, general oncology reach may not be enough.
4. Integration between medical insight and operational planning.
Oncology trials require close coordination between scientific strategy and execution logistics. Protocol design, feasibility modeling, site selection, regulatory planning, and operational delivery are deeply interconnected decisions. Organizations that integrate these perspectives early are better positioned to identify risks before they disrupt the trial.
5. Sponsors should consider global strategy earlier than they often do.
Clinical trials now operate across healthcare systems with varying diagnostic capabilities, regulatory requirements, and infrastructure maturity. A protocol that functions smoothly in one region may face unexpected challenges elsewhere. Anticipating those differences early can reduce delays and improve enrollment stability.
Choosing a CRO is ultimately a risk decision
We have seen how some sponsors in the past have turned CRO selection into a procurement exercise when it should actually be a strategic corporate decision about how execution risk will be managed.
This is because sponsors do not engage a CRO merely to execute tasks. They should rely on that partner to anticipate operational challenges, align trial design with real world clinical practice, and maintain access to the patient populations that determine whether the study succeeds.
The right partner should demonstrate how its expertise will materially influence protocol design, site strategy, patient identification, regulatory planning, and the countless operational decisions that shape the trajectory of a clinical trial. That is why sponsors should stop treating oncology expertise as a marketing claim and manage it as a core diligence question when initiating an oncology study.