RWE 101 – Project Managers

Real-World Evidence (RWE) observational studies and clinical trials are both key elements of medical research, but they involve very different methodologies, aims, and requirements. As a result, the role of a project manager in each type of study will differ significantly.
Here’s a high-level overview of how the role of a project manager differs for RWE observational studies versus clinical trials:
[1] Study Design and Execution: In RWE studies, the project manager has to deal with more varied and unpredictable study designs since these studies often rely on data that is collected during routine clinical practice. This role requires a higher degree of flexibility and the ability to adjust study plans and analysis methods as new data becomes available.
[2] Regulatory Compliance: Clinical trial project managers have to comply with strict regulations based on guidelines such as Good Clinical Practice (GCP). Whereas, the regulatory landscape for RWE studies is more varied, with guidelines and norms often differing by data source and locality. However, RWE studies are increasingly being used in regulatory decision-making, so there is a growing focus on maintaining data quality and ensuring appropriate use of data.
[3] Data Management: In clinical trials, project managers oversee data is gathered in a very structured way with predefined data points. Project managers in RWE studies deal with large, real-world data sets that can come from a variety of sources, like electronic health records (EHRs), insurance claims data, or patient registries. They have to manage complex, unstructured data and may have to deal with issues related to data cleaning, missing data, or data integration.
[4] Stakeholder Engagement: Project managers for clinical trials and observational studies must coordinate with a variety of stakeholders, including clinicians, patients, sponsors, regulatory bodies, and ethics committees. They have to manage patient recruitment and retention, monitor trial progress, and handle any issues that arise during the trial.
[5] Analysis and Reporting: For both clinical trials and observational studies project managers play a crucial role in ensuring that analysis is conducted as per the pre-specified statistical analysis plan and results are reported in a standardized format. Project managers overseeing RWE studies have to navigate more complex and varied analysis strategies due to the nature of the data. They may also have to engage more with stakeholders to communicate findings and their implications, and reporting may be more tailored to the needs of specific stakeholders.
In both types of studies, the project manager is responsible for ensuring the project is delivered on time, within budget, and to a high standard of quality. However, the specifics of what this involves can vary considerably depending on whether the study is a clinical trial or an RWE observational study.

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