A Guide to Starting a Real-World Evidence Project: Self-Solutioning Steps
Before embarking on a real-world evidence (RWE) project, it’s crucial to ensure proper planning and preparation. Here is a self-solutioning checklist that outlines key steps:
Define Objectives and Research Questions:
- Define the objectives of the RWE project.
- List specific insights or evidence you are seeking to generate.
- Identify key research objective(s). Here are a few examples of RWE studies and use cases:
- Medical Affairs/HEOR use cases - natural history of disease, patient journey, treatment patterns, outcomes study, comparative effectiveness, HCRU, prevalence study, etc.
- Commercial use cases - market assessment, patient segmentation, provider mapping, market tracking, referral patterns, etc.
- Formulate research questions that align with the key objectives and will guide the study design, data requirements and analytical plan.
- Define timelines. Are there target conferences for publications? Is there an internal urgency?
Identify Stakeholders and Collaborators:
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Identify all cross-functional stakeholders involved in the project, including researchers, clinicians, data scientists, regulatory experts, and decision-makers.
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Establish collaboration with relevant partners to access necessary data sources and expertise.
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Determine if your organization could benefit from an RWE Center of Excellence.
Understand Regulatory Requirements:
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Familiarize yourself with the regulatory landscape governing RWE studies in your jurisdiction, such as FDA guidelines in the United States or EMA regulations in Europe.
Data Source Identification and Access:
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Identify fit-for-purpose data source(s) that will be utilized for the RWE study.
Datasets and data partners should be evaluated based on the following attributes:
- Quality trusted data sources
- Sufficient volume of data for the disease/treatment of interest
- Availability of key data elements (e.g., clinical outcomes)
- In-house data services expertise
- Data or services timelines to align with your deadlines
- Accessibility and availability of these data sources, including any data sharing agreements or access restrictions
Data Quality Assessment:
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Assess the quality, completeness and reliability of the selected data sources. Evaluate factors such as data accuracy, consistency, and timeliness.
By following these steps, you can lay a solid foundation for a successful RWE project, enabling you to generate meaningful insights that will help inform healthcare decision-making and improve patient outcomes.