Increasing capabilities in real-world evidence (RWE) development, a larger focus on patient centricity, and the limitations of evidence derived from randomized controlled trials (RCTs) have all led to a greater focus on the use of pragmatic studies to support health care decisions and market access. Pragmatic studies aim to quantify the risks, benefits and costs of an intervention in routine clinical practice, often helping to inform how a treatment may be applied by clinicians outside of the clinical trial environment. Considered quasi-experimental, pragmatic trials invoke randomization, typically involve a broader range of patients, study sites, and outcomes, including a greater emphasis on quality of life and long term functional impact, than the typical RCT.
Achieving stakeholder evidence needs requires a diverse portfolio of observational and interventional RWE research methods. The case is more compelling than ever for the conduct of more efficient clinical research to enhance the value of healthcare. Innovative approaches to randomized trials can bridge the intersection of observational RWE and the conventional RCT and provide
Evidera’s global team of over 1,000 operations professionals are experts in designing and executing studies that fall across the RCT-pragmatic study spectrum. We are able to leverage the depth of expertise of PPD’s therapeutic area strategy teams, working groups in adaptive design and collaborative trials, and technical expertise in biostatistics, regulatory affairs, biomarkers and other aspects of clinical development.