Real World Evidence (RWE) 101 – Study Conduct

RWE 101 – Study Conduct

Once the study has been set up, the study conduct phase begins. This phase includes several key activities that ensure the smooth running of the study and the collection of high-quality data. Here are some of the key study conduct activities in the context of Real-World Evidence (RWE) studies:
[1] Patient Enrolment and Follow-up: After obtaining informed consent, patients are enrolled in the study according to the criteria outlined in the study protocol. The enrolled patients and/or their healthcare data are then followed up at regular intervals. Observational study designs seek to mirror routine clinical practice as closely as possible.
[2] Data Collection: This involves gathering data according to the study protocol. The data can come from a variety of sources, such as electronic health records (EHRs), insurance claims databases, patient registries, or directly from patients via surveys or interviews. Data collection must be systematic and standardized to ensure data quality and reliability.
[3] Monitoring and Quality Control: Monitoring is done (recommended by the FDA and AEMPs) to ensure that the study is being conducted according to the protocol and that data is being collected accurately and consistently (especially safety data). This could involve site visits by clinical research associates, remote monitoring, or data audits.
[4] Safety Monitoring: Any adverse events or side effects reported by patients to/by clinicians are recorded and reported to the appropriate authorities. Reporting requirements differ by region.
[5] Interim Analysis: Depending on the study design, interim analyses may be conducted at certain points during the study. This can allow early detection of safety issues or indications of effectiveness.
[6] Vendor Management: If vendors are being used for services such as data analysis or lab testing, regular communication is required to ensure that the work is being done according to the agreed timelines and standards.
[7] Regulatory Compliance: Throughout the study, all(regional) regulatory requirements must be followed. This includes maintaining proper documentation, protecting patient privacy, and reporting to regulatory bodies as required.
[8] Communication and Reporting: Regular updates about the study progress are typically provided by the study sponsor, to the investigators, the ethics committee or IRB, and any other relevant stakeholders.
These activities continue until all patients have been enrolled and all data has been collected. The study conduct phase is critical for ensuring that the data collected is reliable and that the results of the study will be scientifically valid and useful for informing healthcare decisions.

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