Case studies

**How we help overcome complex evidence and access challenges**

Review selected case studies to see how we support critical life sciences decisions across therapeutic areas through evidence, experience, and judgment

EVIDENCE SYNTHESIS CASE STUDY

Targeted literature review for lung cancer RWE to support HTA submission

There was a lack of literature and randomized controlled trial data evaluating the post-surgery follow-up care among early non-small cell lung cancer (eNSCLC) patients who experienced locoregional recurrence. The client required literature review expertise to assess the current state of the eNSCLC outcomes.

Genesis Research Group collaborated with the client to design and conduct a targeted literature review (TLR) to analyze survival and treatment patterns outcomes in observational studies.

Ultimately, the data obtained were used to support inputs for economic models and a health technology assessment (HTA) submission.

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EVIDENCE STRATEGY/IEP CASE STUDY

Strategic support with new rare disease indication

The client requested support in planning short- and long-term HEOR strategies.

Because the client’s pipeline indications involved rare disease populations with limited existing data, developing an evidence base required a tailored approach, including natural history studies, registry-based analyses, and de novo data collection.

We collaborated with the client to develop a customized strategy to build an evidence base for pipeline indications and a custom integrated evidence platform (IEP) that boosted internal communication and knowledge management across the global organization.

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HEOR CASE STUDY

Evaluating HCRU and burden of illness in focal segmental glomerulosclerosis

Focal segmental glomerulosclerosis (FSGS) is a varied, complex pattern of kidney damage with several different causes, names, terminology, and proposed classification systems.

Evidence generation required (1) claims to summarize the cost and HCRU burden and (2) clinical data (e.g., labs from EHR) to accurately identify patients in the study cohort.

We collaborated with the client to develop a protocol and analysis plan.

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RWE DASHBOARD CASE STUDY

RWE dashboards using EHR and claims data

A client responsible for guiding internal decision-making with real-world evidence needed to generate RWE in a way that was rapid, rigorous, transparent, and easy to communicate internally.

Genesis Research Group collaborated with the client to create a set of highly customized RWE dashboards for a solid tumor using EHR and claims data. These dashboards enabled the client to share RWE insights internally through a rigorous, transparent, and accessible format.

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RPR CASE STUDY

Obtaining insights on a trial design for an external control arm in multiple myeloma

A new drug was being investigated in a single-arm study to evaluate its efficacy and safety in participants with multiple myeloma (MM). The client needed to generate evidence on the standard of care, achievable by creating an external control arm using real-world data.

RPR was used to obtain key KOL and payer insights on the appropriate study design elements required to build a robust external control arm.

Within three weeks, RPR gathered insights that allowed the client to identify best and worst practices for designing an external control arm (ECA) and confirmed that publication of final results in a peer-reviewed journal was the evidence payers considered most important.

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115

innovative companies supported by our work

1,000

scientific publications by current team members

3,500

experts in our stakeholder engagement network

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