Real World Data

The Real World Data initiative aims to collaborate with global regulatory agencies to develop a framework for RWD that defines tools, methodologies, use cases, and appropriate levels of evidence to support regulatory decision-making.

Rationale

Supplementing or replacing clinical trial data with Real World Data (RWD) to inform regulatory decisions is a transformative, ambitious goal that has the potential to substantially contribute to the totality of evidence regarding the benefits and risks of drug products. Leveraging RWD can benefit both patients and researchers.

Benefits

  • Enhanced evidence generation through RWD potentially leading to improved patient outcomes
  • Enhanced credibility and increased awareness of appropriate use of RWD
  • Increased confidence in acceptance of RWD for regulatory decision making

Similar Initiatives

Historical Trial Data Sharing (Controls) Solutions

The Historical Trial Data Sharing Initiative enables the sharing of historical trial data to maximize the value of clinical data collected in the control arms of clinical trials. Explore the materials below to learn more about our findings. Please note, the Historical Trial Data Sharing Initiative was formerly known as “Placebo and Standard of Care.”

eSource Solutions

What is eSource? The Food and Drug Administration (FDA) defines eSource, or electronic source data, as data initially recorded in an electronic format. The TransCelerate eSource workstream further categorizes eSource into the four groups shown below: *The eSource team recognizes that some technologies may apply to more than one modality and that these modalities will

Digital Data Flow Solutions

TransCelerate’s Digital Data Flow initiative is an attempt to enable the flow of digital study protocol data in order to improve study design and accelerate start-up through automation of processes and setup of study execution systems. Currently, Study Start-Up (SSU) is comprised of a myriad of multifaceted, multifunctional, multisystem assets created and managed in a