Oncology is often discussed as a single therapeutic area, but a trial in metastatic breast cancer and a trial in a rare sarcoma share little beyond the word “cancer.” Tumor biology, standard imaging methods, response criteria, and even how patients are found and referred differ substantially between solid tumors, hematologic malignancies, and rare cancers. This is why specialized oncology CROs often structure their teams and processes to account for tumor-specific requirements rather than applying a single generic oncology approach across every study
Why Oncology Requires Its Own Organizational Approach
A CRO running an oncology-heavy portfolio typically needs staff who understand disease-specific endpoints, imaging conventions, and site networks well enough to spot problems in a protocol before a study begins, not after enrollment stalls. Tigermed describes its own approach along these lines, with a dedicated oncology cros project team structured around medical science, operations, regulatory affairs, and participant recruitment specifically for cancer studies, rather than folding oncology into a broader general-medicine team.
This kind of dedicated structure matters because oncology protocol design decisions — which response criteria to use, how often to schedule imaging, which sites can realistically identify eligible patients — depend heavily on which category of cancer a study is targeting. A generalist approach applied uniformly across solid tumors, blood cancers, and rare indications tends to produce protocols that are a reasonable fit for none of them.
Solid Tumors and RECIST-Based Protocol Design
For many solid tumor trials, RECIST 1.1 is a widely used framework for assessing whether measurable disease is shrinking, stable, or progressing. RECIST 1.1 defines specific rules — up to five target lesions total, a maximum of two per organ, defined size thresholds for what counts as a measurable lesion, and specific percentage thresholds separating partial response, stable disease, and progressive disease.
Because these rules are technical and specific, protocol design for a solid tumor trial has to account for imaging frequency, the qualifications of the radiologists reading scans, and whether independent central review of images will be required. A team experienced in solid tumor trials generally recognizes these requirements as a baseline expectation rather than a special request, which can reduce the number of protocol amendments needed after a study is already underway.
Hematologic Malignancies: A Different Response Framework Entirely
Lymphoma trials generally require lymphoma-specific response criteria rather than relying solely on RECIST 1.1. The Lugano classification, which incorporates both PET and CT imaging, is the standard response framework for lymphoma trials, and it differs meaningfully from RECIST’s approach — Lugano criteria interpret metabolic activity captured by PET scans alongside anatomical tumor size, rather than relying on anatomical measurement alone.
This distinction has direct consequences for protocol design and site selection. A site with strong CT-based tumor measurement infrastructure is not automatically equipped to support PET-based lymphoma response assessment, and radiologists trained primarily in solid tumor imaging may need additional support interpreting Lugano-based scans. A CRO’s hematology-oncology experience is generally reflected in whether these imaging and interpretation requirements are addressed at the protocol design stage rather than discovered mid-study.
Rare Cancers and the Site Selection Problem
Rare and less common cancers can create a different enrollment challenge because eligible patients may be fewer and more geographically dispersed, with referral patterns often concentrated around specialized centers. Tigermed‘s own published oncology experience spans a range of indications, including lower-incidence cancers and tumor types such as bile duct cancer and brain glioma alongside more prevalent cancers such as breast and colorectal cancer.
For a rare cancer study, site selection generally has to prioritize centers with an established referral pattern for that specific tumor type, since a site without existing patient flow for a rare indication may struggle to enroll even a small target number of participants. This is different from a common solid tumor trial, where a broader network of general oncology sites may be sufficient to meet enrollment targets.
Patient Recruitment Strategies Adjusted by Tumor Type
Recruitment approaches also shift depending on tumor category. Trials for biomarker-defined subsets of a common cancer — for example, a specific mutation within non-small cell lung cancer — generally require prescreening infrastructure to identify eligible patients from a larger population, since the qualifying biomarker itself narrows the pool substantially even when the overall cancer type is common. Rare cancer trials, by contrast, often depend more on relationships with a small number of high-volume referral centers and patient advocacy networks than on prescreening large general populations.
Hematologic malignancy trials sit somewhere between these approaches, often drawing on a mix of academic hematology centers and community oncology practices depending on the specific blood cancer and treatment line being studied. A CRO’s recruitment strategy is generally more effective when it is built around these distinctions from the start, rather than applying one recruitment playbook across every oncology protocol regardless of tumor type.
Matching CRO Experience to Tumor-Specific Needs
Sponsors evaluating a partner for oncology drug development are generally advised to ask specifically about a CRO’s experience with their tumor type’s response criteria, imaging requirements, and relevant site networks, rather than treating general oncology experience as sufficient on its own. A CRO with extensive solid tumor experience under RECIST 1.1 should not be assumed to have equivalent experience with lymphoma-specific response assessment or with identifying referral networks for rare sarcoma studies.
Companies such as Tigermed, which describe organizing oncology work around a dedicated project team spanning medical science, operations, regulatory affairs, and recruitment, illustrate one structural approach to addressing this kind of tumor-specific variation. As with any specialized therapeutic area, sponsors are advised to confirm a CRO’s specific experience with their particular tumor type and study phase before finalizing a selection.
