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.

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