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Real World Evidence (RWE) 101 – Verifying the Source of Data (Not to be Confused with Source Data Verification…Yup! Confusing!)

RWE 101 – Verifying the Source of Data (Not to be Confused with Source Data Verification…Yup! Confusing!)

Verifying the source of data is critical in the context of real world evidence (RWE) because the quality and reliability of the data are essential for generating accurate and trustworthy evidence. RWE is derived from real-world data (RWD), which is often collected from a variety of sources, including electronic health records (EHRs), claims databases, patient registries, and wearable devices.

There are several reasons why it is important to verify the source of RWD used to generate RWE:

Data quality: The quality of RWD can vary depending on the source, and it is essential to ensure that the data used to generate RWE are of high quality. Verification of the data source can help ensure that the data have been collected and managed in accordance with accepted standards and best practices.

Data completeness: Ensuring that the RWD used to generate RWE are complete and accurate is critical to the validity and reliability of the evidence. Verification of the data source can help ensure that all relevant data have been captured and that there are no gaps or inconsistencies in the data.

Data relevance: RWE is generated from RWD that may come from diverse sources, and it is important to verify that the data are relevant to the research question or hypothesis being investigated. Verification of the data source can help ensure that the data used to generate RWE are appropriate for the research question being addressed.

Data bias: RWD can be subject to various types of bias, including selection bias, measurement bias, and confounding bias. Verification of the data source can help identify potential sources of bias and enable appropriate adjustments to be made to the analysis to account for any bias.

In summary, verifying the source of data used to generate RWE is critical to ensure that the evidence generated is accurate, reliable, and trustworthy. It can help ensure that the data are of high quality, complete, relevant, and free from bias, which are all essential for generating high-quality evidence that can inform clinical decision-making and healthcare policy.

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Real World Evidence (RWE) 101 – Verifying the Source of Data (Not to be Confused with Source Data Verification…Yup! Confusing!)2023-08-07T11:35:44+00:00

Real World Evidence (RWE) 101 – Is ‘Retrospective Data’ the Same as ‘Secondary Use of Existing Data’?

RWE 101 – Is ‘Retrospective Data’ the Same as ‘Secondary Use of Existing Data’?

Retrospective data generally refers to data that has already been collected for another purpose and is being used retrospectively to answer a new research question. This data can come from various sources, such as electronic health records, claims databases, or patient registries, and is often used to generate RWE.

On the other hand, secondary use of existing data refers to the practice of using existing data for a purpose other than the one for which it was originally collected. This can include using data from clinical trials for post-market surveillance or using data from a patient registry for comparative effectiveness research.

While retrospective data can be one type of existing data that is used for secondary purposes, not all secondary uses of data involve retrospective data. For example, prospective data collected for one purpose, such as routine clinical care, can be used for secondary purposes, such as generating RWE.

In summary, retrospective data and secondary use of existing data are related but not interchangeable terms in the context of RWE. Retrospective data is a type of existing data that can be used for secondary purposes, but not all secondary uses of data involve retrospective data.

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Real World Evidence (RWE) 101 – Is ‘Retrospective Data’ the Same as ‘Secondary Use of Existing Data’?2023-08-07T23:11:48+00:00

Real World Evidence (RWE) 101 – EHDS and GDPR – How does GDPR support the secondary use of existing health data for the purposes of scientific research?

RWE 101 – EHDS and GDPR – How does GDPR support the secondary use of existing health data for the purposes of scientific research?

The GDPR (General Data Protection Regulation) includes provisions that support the secondary use of existing health data for scientific research purposes, while also protecting the privacy and data protection rights of individuals.

One of the key ways that the GDPR supports the secondary use of health data for research is through the concept of “legitimate interests”. Article 6(1)(f) of the GDPR allows for the processing of personal data if it is necessary for the legitimate interests of the data controller or a third party, provided that those interests do not override the fundamental rights and freedoms of the data subject. Scientific research can be considered a legitimate interest, provided that appropriate safeguards are in place to protect individuals’ rights and freedoms.

In addition, the GDPR includes provisions that specifically address the use of health data for scientific research. For example, Article 9(2)(j) allows for the processing of special categories of personal data, such as health data, for scientific research purposes, provided that appropriate safeguards are in place.

The GDPR also requires that data controllers implement appropriate technical and organizational measures to ensure the security and confidentiality of personal data, including health data. This includes requirements for data pseudonymization and encryption, as well as procedures for data breach notification.

Overall, the GDPR strikes a balance between protecting individuals’ privacy and data protection rights, and supporting the important public interest in scientific research. By providing a framework for the responsible and transparent use of health data for research purposes, the GDPR can help to facilitate the development of new treatments and interventions that can improve public health outcomes.

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Real World Evidence (RWE) 101 – EHDS and GDPR – How does GDPR support the secondary use of existing health data for the purposes of scientific research?2023-08-07T23:09:58+00:00

Real World Evidence (RWE) 101 – The Impact of GDPR on RWE Research

RWE 101 – Real World Evidence (RWE) 101 – The Impact of GDPR on RWE Research

The General Data Protection Regulation (GDPR) is a regulation in EU law on data protection and privacy for all individuals within the European Union (EU) and the European Economic Area (EEA). Its implementation in May 2018 has had a significant impact on research, particularly in the context of real-world evidence (RWE).

RWE refers to data collected outside of the traditional clinical trial setting, such as electronic health records (EHRs), claims data, and patient-generated data. RWE is increasingly being used to support regulatory decisions and to inform clinical practice. However, the use of RWE must comply with GDPR, which has implications for the collection, processing, and use of personal data in research.

Under GDPR, personal data must be collected and processed lawfully, fairly, and transparently, and individuals have the right to be informed about how their data is being used. This means that researchers must obtain explicit and informed consent from individuals to use their personal data for research purposes. In addition, the data must be pseudonymized or anonymized to protect individuals’ privacy.

GDPR has also increased the administrative burden for researchers, who must ensure that their data management practices are compliant with GDPR. This includes developing and implementing policies and procedures for data protection, privacy, and security, as well as appointing a Data Protection Officer to oversee data management activities.

Overall, GDPR has had a positive impact on research by increasing transparency and protecting the privacy of individuals whose data is used in research. However, compliance with GDPR can be challenging, particularly in the context of RWE, where large volumes of data are collected from multiple sources. It is essential for researchers to work closely with data protection and privacy experts to ensure that their research practices are compliant with GDPR.

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Real World Evidence (RWE) 101 – The Impact of GDPR on RWE Research2023-08-07T22:51:18+00:00

Real World Evidence (RWE) 101 – Primary Data versus Secondary Data

RWE 101 – Primary Data versus Secondary Data

Primary data and secondary data are two types of data used in research. The main difference between the two is that primary data is collected directly from the source, while secondary data is collected from sources that have already collected the data.

Primary data is original data that is collected for a specific research project. This type of data can be collected through various methods, including surveys, interviews, observations, and experiments. Primary data is collected with a specific research objective in mind, and the data is usually more focused and targeted than secondary data.

On the other hand, secondary data is data that has already been collected by someone else for a different purpose. This type of data can be collected from a wide variety of sources, including healthcare organisations, government agencies, academic institutions, and commercial organizations. Secondary data can be used to supplement primary data or to answer research questions that are not directly related to the original research objective.

There are advantages and disadvantages to both types of data. Primary data is more likely to be accurate and relevant to the specific research question being studied, but it can also be more time-consuming and expensive to collect. Secondary data is generally less expensive and easier to access, but it may not be as accurate or relevant to the specific research question being studied.

In general, researchers will use a combination of primary and secondary data to address their research questions and achieve their research objectives

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Real World Evidence (RWE) 101 – Primary Data versus Secondary Data2023-08-07T22:47:38+00:00
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