Real-World Evidence (RWE) studies are on the rise in healthcare, offering valuable insights into how treatments fare in everyday clinical settings. Compared to traditional RCTs (randomized controlled trials), RWE studies boast the advantage of potentially lower costs. But even within the realm of RWE, expenses can vary. Let's delve into the key factors that contribute to the cost of RWE studies, along with a ballpark range of USD 80,000 to USD 2,000,000 to consider.

Data Source and Quality:

Data Type: Extracting and cleaning data from disparate sources like EHRs, claims databases, and patient registries can be labor-intensive. The cost hinges on the type and complexity of the data source. Readily available data (EHRs) might be cheaper than specialized data (patient registries) requiring additional processing (potential cost impact: low to high).

Data Cleaning and Harmonization: Messy or incomplete data from different sources necessitates cleaning and harmonization for consistency. This process requires expertise and specialized tools, impacting the overall cost (potential cost impact: moderate to high).

Study Design and Complexity:

Study Type: Retrospective studies, analyzing existing data, are generally less expensive than prospective studies that actively collect new data over time. Retrospective studies typically fall on the lower end of the cost range (USD 80,000 - USD 500,000), while prospective studies can climb higher due to additional requirements (prospective studies can range from USD 500,000 to USD 2,000,000+).

Number of Variables: Studies with a larger number of variables to analyze, requiring complex statistical methods, will likely cost more than simpler studies with fewer variables (potential cost impact: low to moderate).

Sample Size: Studies involving a larger patient population necessitate more data analysis and potentially more robust computing power, increasing the cost (potential cost impact: moderate to high).

Data Security and Privacy:

Data Security Measures: Ensuring patient privacy and data security throughout the research process necessitates robust security protocols and anonymization techniques. These measures add to the overall expense (potential cost impact: moderate).

Regulatory Compliance: Meeting data privacy regulations like HIPAA (US) or GDPR (Europe) can involve additional costs for ensuring compliance protocols are followed (potential cost impact: low to moderate).

Additional Considerations:

Study Duration: Longer studies require more data storage and potentially ongoing data cleaning efforts, impacting the cost (potential cost impact: low to moderate).

Frequency of Touch Points: Studies requiring more frequent interaction with participants, such as surveys or exams, will be more expensive than those with fewer touch points (potential cost impact: low to high).

Complexity of the Study Methodology: Studies with more intricate designs or methodologies will require more expertise and resources, driving up the cost (potential cost impact: moderate to high).

Regulatory Approvals: Studies needing extensive regulatory approvals may incur additional costs associated with the application process (potential cost impact: low to moderate).

Compensation Offered to Investigators and Participants: The cost of compensating investigators for their time and expertise, as well as any incentives offered to participants, can vary depending on the study (potential cost impact: moderate to high).

Remember, this is a ballpark range. The specific cost of your RWE study will depend on the unique combination of these factors. By understanding these variables, you can get a clearer picture of the potential costs involved and make informed decisions when planning your RWE study.

At Pro Pharma Research Organization we have Real-World Data/Evidence Services for Pharma and Healthcare Industry, within which are Data Collection and Integration, Data Cleansing and Validation, Evidence Generation, Healthcare Outcome Analysis, among others, contact us to access more information.

Publication date: June 2024

Author: Pro Pharma Research Organization Team