#12 Practical RWE – Training: Study Team Training


Study team training is crucial in both Real-World Evidence (RWE) studies and clinical trials, but the importance and focus of the training can vary significantly due to the different natures and objectives of these two types of studies.

  1. Nature of Data Collection:

– In clinical trials, data is collected under controlled conditions with predefined protocols. Training emphasizes adherence to these protocols, ensuring uniformity and minimizing bias.

– RWE studies, on the other hand, use data from sources like electronic health records, insurance claims, or patient registries. Training here focuses on understanding these data sources, identifying relevant data, and ensuring its quality and integrity.

  1. Regulatory Compliance and Guidelines:

– Clinical trials are highly regulated with strict guidelines for conduct. Training ensures compliance with these regulations, including patient safety and reporting requirements.

– RWE studies, while still subject to regulatory considerations, have different compliance requirements. Training helps in understanding these nuances and applying appropriate methodologies.

  1. Study Design and Methodology:

– Training for clinical trials includes detailed study design, placebo controls, blinding methods, and other experimental procedures.

– In RWE studies, training focuses more on observational study designs, statistical methods for handling real-world data, and techniques for reducing bias in non-randomized settings.

  1. Patient Interaction and Consent:

– Clinical trials usually require direct patient interaction, informed consent, and continuous monitoring. Training includes effective communication with participants and managing adverse events.

– RWE studies often use existing data where direct patient interaction is minimal. Training focuses more on data privacy, patient consent in the context of data use, and ethical considerations.

  1. Data Analysis and Interpretation:

– Clinical trial training includes specific methods for analyzing clinical data and interpreting results according to clinical endpoints.

– In RWE studies, training often covers a broader range of data analysis skills, including dealing with large datasets, diverse data types, handling missing data, and applying real-world evidence to clinical or policy decisions.

  1. Collaboration and Multidisciplinary Understanding:

– Both study types require understanding roles across disciplines. However, RWE studies often involve more diverse teams (e.g., data scientists, health economists, healthcare providers, policy makers) and thus require training in effective cross-disciplinary collaboration.

In summary, while study team training is fundamental in both clinical trials and RWE studies for ensuring quality, compliance, and reliability of results, the specific focus of the training differs to cater to the unique challenges and objectives of each study type.

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