RWE 101 – Challenges Pharma Companies Face when Using RWE to Support Marketing Authorisations

Real-world evidence (RWE) studies include observational studies that uses data collected in real-world settings to investigate the safety and effectiveness of drugs and medical devices. While RWE studies can provide valuable insights into the use of medications in real-world settings, pharmaceutical companies face several challenges when using these studies to support marketing authorizations:

1. Data quality and availability: The quality and availability of real-world data can be a significant challenge for pharmaceutical companies when running RWE studies. Data sources may be incomplete, inconsistent, or difficult to access, making it difficult to draw accurate conclusions from the data.

2. Data privacy and confidentiality: Data privacy and confidentiality regulations such as GDPR can make it difficult to obtain and use patient data for RWE studies. Companies may need to navigate complex legal frameworks to obtain the data they need while ensuring that patient privacy is protected.

3. Study design and bias: RWE studies are observational and not randomized controlled trials, which makes them more susceptible to bias. Companies need to carefully design and conduct RWE studies to minimize the risk of bias and ensure that the results are reliable and representative of real-world settings.

4. Data analysis and interpretation: Analyzing and interpreting RWE data can be challenging due to the complexity of the data and the potential for bias. Companies may need to employ advanced statistical techniques to ensure that the data is analyzed accurately and that the results are valid and reliable.

5. Regulatory acceptance: Regulatory authorities may be hesitant to accept RWE studies as evidence to support marketing authorizations. Companies need to work closely with regulatory authorities to ensure that their RWE studies meet the necessary standards for regulatory acceptance.

In conclusion, pharmaceutical companies face several challenges when running RWE studies to support marketing authorizations. To overcome these challenges, companies need to carefully design and conduct studies, ensure data quality and privacy, and work closely with regulatory authorities to demonstrate the validity and reliability of their results.

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