Pragmatic Studies

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.

Innovative Approaches to Trials

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

  • Patients with better information on treatment options, benefits and risks, and health outcomes that matter to them
  • Patients with multiple conditions and to compare the effectiveness of medical treatments
  • Medical providers with evidence needed to more effectively treat patients with multiple conditions and to compare the effectiveness of medical treatments
  • Medical product developers with new insights on both new and existing therapies and unmet medical needs
  • Regulators with better information to understand the effectiveness and safety of medical treatment options in broader patient groups
  • Payers with better information to understand the benefit risk and value of medical treatment options

We Can Help You Design and Execute Pragmatic Studies to

  • Study a broader patient population
  • Study comparators, outcome measures, treatment pathways, and sites/patients that are representative of usual care settings
  • Establish effectiveness in subgroups of the general population, especially those excluded from conventional RCTs
  • Measure differences in administration of an intervention (e.g. differences in routine practice versus RCT)
  • Understand real-world adherence
  • Understand acceptability for patients in real practice
  • Determine evidence gaps for comparisons with routine standard of care
  • Determine the position of new treatments within current treatment paradigms

Excellence in Study Design and Execution

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.

Experts

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