Real World Database Studies: Eight Key Steps to Success
White Paper
Dec 04, 2019

Interested in using secondary real world data (RWD) to answer specific research and business questions? Read this white paper and discover eight key steps for planning, executing, and reporting high-quality retrospective database studies to ensure robust results for submissions to healthcare decision-makers.

This white paper is designed for individuals within the pharmaceutical industry who are looking to use secondary real world data (RWD) sourced from preexisting administrative or clinical databases to answer specific research and business questions. It is intended as a top-level guide on planning, executing and reporting a high-quality retrospective database study to ensure robust results for submission to healthcare decision-makers.


Healthcare decision-makers have become increasingly aware of the need to understand the impact of interventions in the real world setting, using RWD. The greater reliance on RWD in part stems from a gradual shift in the timing of drug appraisals, which are now being conducted much sooner in the product lifecycle. It also reflects growth in models of earlier access to treatment, adaptive licensing and management entry agreements, which generally involve provisional approval contingent on further data. Re-assessment of these treatments using data collected through product use can help to support subsequent decisions. RWD also now plays a key role in informing decisions about appropriate access and reimbursement, better outcomes measurement and drug development decisions across the lifecycle.

Retrospective database studies are of growing interest to decision-makers seeking to measure the effects of treatments in real world use. There are numerous challenges to conducting these studies. However, by applying rigorous epidemiological principles, involving subject matter experts, and using a robust delivery model, companies can significantly enhance the validity of the results. Best practices for conducting retrospective pharmacoepidemiologic studies using RWD have been published in recent years, providing guidance and recommendations on designing, analyzing and documenting the results.2–12 In this white paper, we provide an overview of the main points that companies should consider when initiating a retrospective study to ensure robust, reliable results.


Given the growing role of real world retrospective database studies and the potential implications of the results, it is important to conduct them with high scientific rigor. We suggest a structured, scientific approach to overcome operational barriers and increase study validity, recognizing the need for a strong epidemiologic design and proven analytical methods to reduce the potential for bias.

Standard operating procedures (SOPs) are essential to ensure consistent practices in RWD study execution across different teams. They are also key to confirming that all research tasks are conducted in accordance with institutional, local and federal guidance. SOPs are typically linked to working documents that provide step-by-step instructions to project teams on the various study-related activities (protocol development, data management, statistical analysis plan (SAP) development, quality control plans, reporting, etc).

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