The path from early scientific discovery to approved oncology therapy is increasingly complex. Precision medicine, biomarker driven development, global regulatory divergence, and rising trial costs demand integrated, evidence led decision making across the drug development lifecycle. Oncology drug development presents many challenges including:<\/p>\n
Successful oncology development begins with a deep understanding of disease biology, therapeutic mechanisms, and patient heterogeneity. Early development decisions must prioritise the correct tumour type and line of therapy, otherwise limiting the ability to demonstrate meaningful clinical value. Patient heterogeneity must also be well understood, factoring in biomarker status, disease stage, and prior treatments. \u00a0Clarivate\u2019s Discovery & Translational Sciences experts apply advanced bioinformatics, systems biology, and AI enabled analytics to support target identification, biomarker discovery, and translational decision<\/strong> making<\/strong> for oncology assets.<\/p>\n Recently, the team published research at the prestigious American Association for Cancer Research (AACR) on the novel role of INCB057643, a bromodomain and extra-terminal (BET) protein inhibitor, in myeloid cell regulation and immunosuppressive tumor environment remodeling in myelofibrosis (MF)[1]<\/u><\/a>, and research that identified that INCA33890 increases CD8+ T-cell effector function compared with pembrolizumab as assessed by single-cell RNA sequencing in human PD-1xTGF\u03b2R2 knock-in mouse model[2]<\/a>.<\/p>\n Leveraging Clarivate\u2019s large-scale biomedical knowledge graph \u2014which incorporates millions of curated molecular interactions, pathways, biomarkers, and clinical relationships, our experts help sponsors identify and prioritize novel oncology targets grounded in mechanistic evidence. Multi-omics integration, including genomic, transcriptomic, proteomic, and single-cell data, enables robust identification of predictive, prognostic, and safety biomarkers that support patient stratification and precision trial design.<\/p>\n Clarivate\u2019s translational teams also analyze large data sets to explore mechanisms of response and resistance, evaluate potential oncology drug combinations, and identify biomarker\u2011defined subpopulations most likely to benefit. These insights inform earlier go\/no\u2011go decisions, reduce late\u2011stage attrition, and strengthen the scientific rationale underpinning oncology drug development strategies.<\/p>\n Oncology drug development is frequently accelerated by skipping or combining phases. Such an approach is driven by a need to shorten overall development times. These strategies, although riskier, rely on early efficacy signals from smaller studies to conduct fewer confirmatory trials.<\/p>\n Clarivate<\/strong>\u2019<\/strong>s Centre for Medicines Research (CMR)<\/strong> International <\/strong>provides world\u2011class, amalgamated and anonymized proprietary benchmarking data that enables sponsors to understand how their oncology programmes compare with industry norms \u2013 and where meaningful improvements can be made.<\/p>\n With more than 40 years\u2019 experience in pharmaceutical benchmarking and proprietary data covering thousands of oncology drugs, development projects, and clinical trials, CMR enables evidence\u2011based assessment of trial cost, cycle time, attrition, protocol complexity, enrollment performance, and site performance<\/strong>. Sponsors can benchmark their oncology pipelines and clinical programmes against peer companies, therapeutic classes, and development phases, using data that are not available in the public domain.<\/p>\n These insights support more accurate forecasting, CRO proposal validation, protocol design optimization, and portfolio\u2011level resource allocation. By anchoring strategic decisions in real\u2011world industry performance, oncology sponsors can reduce uncertainty, anticipate operational risks, and set realistic development targets aligned with commercial and scientific objectives.<\/p>\n Clear differentiation in oncology increasingly depends on selecting the right clinical endpoints <\/strong>and navigating an evolving global regulatory landscape. Regulatory guidance does not always align between regulators and differing expectations can complicate important decisions such as endpoint selection and hierarchy. Clarivate\u2019s Clinical & Regulatory Consulting experts work with oncology sponsors to identify relevant<\/strong>, sensitive, and differential endpoints<\/strong> aligned with disease biology, patient benefit, and regulatory expectations.<\/p>\n Drawing on deep regulatory intelligence across more than 200 global markets, Clarivate advises on optimal development pathways, precedence cases, and submission strategies in the US, Europe, Asia\u2011Pacific, and emerging markets. This includes guidance on accelerated and conditional approval routes, biomarker\u2011linked indications, companion diagnostics, and post\u2011approval commitments.<\/p>\n Recently, the team provided support for regulatory intelligence for advanced therapy products for oncology in global markers, providing requirements for 6 countries and advising on dossier updates to make the sponsors\u2019 submission package compliant with the relevant agencies in each market.<\/p>\n Our teams integrate clinical, regulatory, and competitive intelligence to ensure that oncology trial designs are fit for purpose, globally scalable, and aligned with current and emerging health authority expectations. This reduces approval risk, supports efficient interactions with regulators, and helps sponsors position their oncology assets effectively across regions.<\/p>\n Clarivate\u2019s Clinical Outcomes Assessment (COA) experts help sponsors identify and understand meaningful aspects of health<\/strong> to patients with cancer. We provide support in selecting and developing fit-for-purpose COA measures for clinical trial endpoints that measure what matters most<\/strong>.<\/p>\n Traditionally, treatment endpoints in oncology have focused on increasing overall survival and progression-free survival. However, patients can experience severe symptoms, such as pain and fatigue, substantially impacting their quality of life. We recently published conceptual models of the pain and fatigue experience in oncology, and a preliminary conceptual model in follicular lymphoma to depict the patient experience and guide selection of COAs[3]<\/a> for future clinical trials. Our COA experts also contributed thought leadership on measuring patient-reported tolerability in clinical trials of oncology which was recently presented at ISPOR[4]<\/a>. Measuring symptoms, tolerability, and quality of life from the patient perspective helps drug developers to understand and communicate the totality of evidence, and helps doctors and patients understand the impact of a novel therapy.<\/p>\n We have successfully supported sponsors across many oncology indications. Our team members are experts in understanding how to elicit data from patients, caregivers and clinicians in this challenging disease area and are familiar with the specific guidance and preferred measures to capture concepts such as tolerability and quality of life in oncology. During our research we align with industry standards including the FDA Patient Focused Drug Development (PFDD) Guidance<\/strong> series and the Core Patient-Reported Outcomes in Cancer Clinical Trials[5]<\/a>.<\/p>\n Clarivate also conducts in-trial and exit interviews<\/strong> to explore patient experience, outcomes and understand meaningful changes. Recently, the team published the results of patient reported outcomes (PROs) and qualitative exit interviews from the Phase III EMBER-3 trial in ESMO Open[6]<\/a>. Combining qualitative insights with PRO and other clinical trial data provides valuable context for regulators, payers, and other stakeholders.<\/p>\n Clinical trials in oncology don\u2019t consistently include robust COA endpoints (e.g. patient-reported outcome [PROs]) to support regulatory submissions. Where they are included, the post-approval communication to different stakeholders is also lacking. At Clarivate, we conducted cross-functional research to understand how the inclusion of PROs can be made more consistent and how communication of the PRO related findings can be improved. This work was recently published in BMJ Oncology[7]<\/a>.<\/p>\n From early discovery through regulatory approval and patient centered value demonstration, Clarivate\u2019s R&D Consulting services support sponsors in overcoming the scientific, operational, and regulatory challenges inherent in oncology development.<\/p>\nCentre for Medicines Research International: Benchmarking oncology development against industry reality<\/strong><\/h3>\n
Clinical and regulatory consulting: Optimizing endpoints and global regulatory strategy<\/strong><\/h3>\n
Clinical outcomes assessment: Measuring what matters to patients<\/strong><\/h3>\n
An integrated partner for oncology innovation<\/strong><\/h3>\n