EU | Mapping the Landscape of Data Intermediaries in the Context of the Data Governance Act
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LITHUANIA | Revision to the Law on Reuse of Health Data
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LITHUANIA | Revision to the Law on Biomedical Research Ethics
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- GERMANY | AKEK Statement on the Secondary Use of Patient Data for Research Purposes in Germany Gallery
GERMANY | AKEK Statement on the Secondary Use of Patient Data for Research Purposes in Germany
2023, August 2023, Data Privacy and Data Protection, EHDS, GDPR, Germany, Members-Only, Minor Update, RWD to Support Reg Decisions, Secondary Use of Existing Data
GERMANY | AKEK Statement on the Secondary Use of Patient Data for Research Purposes in Germany
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EU | HealthData@EU Landscape Analysis
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USA | Advancing Real-World Evidence Program Submission Deadline and New FAQs
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- FRANCE | CNIL Publishes Results from its Digital Health Regulatory Sandbox Gallery
FRANCE | CNIL Publishes Results from its Digital Health Regulatory Sandbox
2023, August 2023, Data Privacy and Data Protection, Digital Health, EU, France, GDPR, Members-Only, Moderate Update, RWD to Support Reg Decisions, Secondary Use of Existing Data
FRANCE | CNIL Publishes Results from its Digital Health Regulatory Sandbox
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RWE 101 – Secondary Use of Existing Data
Secondary use of existing data refers to the practice of analyzing data that was collected for a different purpose than the current research question. This approach is becoming increasingly popular in real-world research because of the large amounts of data that are available through various sources, such as electronic health records, administrative databases, and social media.
In many cases, secondary data analysis can provide valuable insights and answer research questions that would otherwise be difficult or impossible to answer with primary data collection. For example, researchers can use existing data to study disease trends, evaluate the effectiveness of health interventions, and identify risk factors for various health outcomes.
Secondary data analysis can also be more cost-effective than primary data collection, as the data has already been collected and often comes at a lower cost than conducting a new study. Additionally, secondary data analysis can allow researchers to study topics that may not have been feasible to study with primary data collection due to ethical or practical limitations.
However, there are also potential limitations to secondary data analysis, such as the lack of control over the quality and accuracy of the data, and the potential for biases and confounding factors that were not accounted for in the original data collection. Therefore, researchers must carefully evaluate the suitability of existing data for their research question and take steps to address any limitations or potential biases in the data.
Real World Evidence (RWE) 101 – Patient Retention
stuart.mccully2023-08-07T17:33:26+00:00August 7, 2023|2023, RWE 101|
RWE 101 - Patient Retention Long-term Real-World Evidence (RWE) studies face significant challenges when it comes to patient retention, for several reasons:[1] Time Commitment: Participants in RWE studies are [...]
Real World Evidence (RWE) 101 – Patient Recruitment
stuart.mccully2023-08-07T17:26:18+00:00August 7, 2023|2023, RWE 101|
RWE 101 - Patient Recruitment Real-world evidence (RWE) is health care information derived from real-world data (RWD). It can be generated through various study designs or analyses, including pragmatic [...]
Real World Evidence (RWE) 101 – HARPER
stuart.mccully2023-08-07T17:19:12+00:00August 7, 2023|2023, RWE 101|
RWE 101 - HARPER Regulatory agencies, health technology assessors, and payers are increasingly interested in studies that make use of real-world data to inform regulatory and other policy or [...]
Real World Evidence (RWE) 101 – STaRT-RWE
stuart.mccully2023-08-07T17:12:23+00:00August 7, 2023|2023, RWE 101|
RWE 101 - STaRT-RWE START-RWE (Structured Template for Planning and Reporting on the Implementation of Real World Evidence Studies) was developed to address the need for improved transparency and [...]
Real World Evidence (RWE) 101 – Protocol Design and ISPE GPP
stuart.mccully2023-08-07T17:03:05+00:00August 7, 2023|2023, RWE 101|
RWE 101 - Protocol Design and ISPE GPP The International Society for Pharmacoepidemiology (ISPE) Guidelines for Good Pharmacoepidemiology Practices (GPP) are a set of best practices for the conduct [...]
Real World Evidence (RWE) 101 – Protocol Design and Scientific Best Practices
stuart.mccully2023-08-07T16:51:55+00:00August 7, 2023|2023, RWE 101|
RWE 101 - Protocol Design and Scientific Best Practices Designing a robust Real-World Evidence (RWE) study is crucial for generating reliable and valid insights that are acceptable to regulators. [...]
GLOBAL | ICH Reflection Paper on Harmonised RWE Terminology
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