Real-World Evidence

Costello Medical understands the importance of real-world evidence (RWE) in demonstrating the clinical and economic value of pharmaceuticals and medical technologies to key stakeholders throughout the product lifecycle. Our team combine clinical, epidemiological and statistical expertise to deliver high-quality real-world studies using a variety of data sources.

Our Expertise

Gap analysis, data landscaping and strategic support

We conduct rigorous gap analysis and identify the most suitable data sources to generate evidence to fill these gaps. All of our RWE projects are designed from the ground up; we do not have proprietary data sources and can therefore tailor our approach to your specific evidence requirements.

Development of protocols and analysis plans

From the outset of each project, we bring together a core project team of disease specialists, epidemiologists and statisticians to design methodologically robust and clinically appropriate RWE studies that meet the identified evidence needs. Our protocols align closely with the Guidelines for Good Pharmacoepidemiology Practices (GPP) from the International Society for Pharmacoepidemiology (ISPE). Our transparent analysis plans provide a comprehensive description of each step of the analysis, from data cleaning to the final statistical models. Where necessary, we prepare all materials for ethics committee or institutional review board (IRB) approval and take on a full project management role for this process.

Analysis of diverse data sources

We design and conduct analyses using a wide range of data sources, including:

Healthcare insurance claims databases
Electronic medical record (EMR) databases
Disease-specific registries
Surveys of patients, clinicians and caregivers
Bespoke chart reviews

Studies on clinical and economic outcomes

We have conducted studies on natural history, clinical and economic burden of disease, treatment landscapes and treatment outcomes. We understand the challenges of developing and validating algorithms to identify specific conditions or events in real-world data sources, and we collaborate closely with the client and external experts to ensure that each step in the analysis is clinically relevant.

Case Studies

Risk Analysis using Claims Data: We designed, conducted and reported an analysis of a large claims/EMR database to explore the risk of a recurrent clinical outcome in patients who had already experienced one event. We prepared the full protocol and analysis plan (including seeking clinical validation of key definitions), dual-programmed the analysis, performed survival analysis and logistic regression to explore the risk factors associated with recurrence of the outcome, and presented our findings in a detailed report that met STROBE reporting guidelines.
Patient and Clinician Surveys: We conducted two surveys (one for patients and one for clinicians) exploring medication adherence, patient-reported outcomes and cost of illness. We started with a targeted literature review and gap analysis, and designed the survey to fill the identified gaps. Content and wording of the survey were designed in collaboration with clinical experts and patient organisations. We also supported the application for ethics review, recruitment of patients, distribution of the survey, statistical analysis, and developing a suite of publications. The results were used as cost-utility inputs model inputs for NICE submissions, and we have developed lay summaries that will be shared on patient organisation newsletters, websites and social media.
Registry Analysis for a Rare Disease: We supported an investigator-initiated retrospective analysis of clinical outcomes collected by a registry of patients with a rare disease. This involved using novel techniques to account for the limited dataset, analyses to assess the appropriateness of the current gold-standard clinical composite outcome measure, and development of a manuscript to communicate the results.