Use cases

A sampling of use cases for applying Aspen to your programs today

| Use Case

Empowering unprecedented real-world analyses of breast cancer screening outcomes

Client Challenge

Generate robust real-world data to evaluate the comparative effectiveness of select mammography screening modalities
Collect patient-level data from diverse real-world sources and transform them into a rich, usable platform for analysis and dissemination
Generate high quality evidence efficiently and quickly to inform national clinical guideline development timelines and support marketing claims

Solution

We developed a large-scale, automated patient registry to:

Collect longitudinal data rapidly, and at scale
Get deep data on cancer risk profiles and outcomes
Reduce enrollment burden on sites
Publish results rapidly
Enable additional studies as needed with minimal effort

| Use Case

Empowering unprecedented real-world analyses of breast cancer screening outcomes

| Use Case

A Reusable Real-World Evidence, Patient Experience and Provider Interaction Platform

Challenge

Traditional study approaches do not provide an automated, leverageable platform and community around a disease. Typically, they are one-way programs with high burden and lower participation than desired. Each study stands on its own rather than being a reusable platform for more programs.

Solution

This evidence generation network provides:

Data to meet a growing range of sponsor evidence needs and a reusable infrastructure for multiple studies
Patient interaction with PRO collection and a patient portal with access to analytics and a daily health journal
Physician portal with individual patient, population and benchmarking insights

Retrospective & prospective
10,000 patients
~10 sites

| Use Case

Support post market commitments and expand label for a lower age group

Challenge

RWD is needed to evaluate the effectiveness of a screening device for colorectal cancer (CRC) in high-risk patients. Study is currently in progress

Solution

We are conducting an observational, prospective multi-center study to collect data, including:

EMR, laboratory, pathology and radiology, and in vitro diagnostic data
Structured and unstructured data (e.g., pathology reports)

from Integrated Delivery Networks (IDNs), hospital systems and large medical practices

~50,000 total patients
~10 sites
5 years

| Use Case

Evaluate real-world effectiveness on burden of disease

Challenge

CF is associated with significantly lower quality of life and a high disease burden
Evaluate the change in patient-reported and caregiver-reported burden of disease after initiating CF treatment.

Solution

Conducted an observational study to evaluate the real-world effectiveness of treatment on patient and caregivers’ burden of illness
PROs and Caregiver Reporter Outcomes were collected every 2 months
Described select clinical outcomes

Targeting ~300 patients for enrollment
Retrospective & Prospective
2 year study

| Use Case

Gain a Deeper Understanding of the Patient Experience with a RWD Research Platform

Challenge

Rare oncology conditions are difficult to study because of competing trials and difficulties in accruing patients. Regulatory and other RWE study needs can be met using a more automated approach that significantly increases the numbers of patients participating.

Solution

OM1 designed a research network for regulatory-grade, RWD to supplement results from a previous Phase 3 study. The approach:

Enabled rapid collection, digitization and continuously flowing data including LTFU and death data on a real-world cohort of oncology patients
Supported overall survival analysis to bolster client’s RWE needs.

Retrospective & prospective
300 patients
~10 sites
~24 months