Purpose of Real-World Evidence/Real-World Data

To test new treatments, pharmaceutical companies adopt a method called “Randomized Controlled Trial” (RCT). There are two design groups within a trial. Participants from the “Randomized” group are chosen randomly to receive a new treatment, but it is a fake treatment. The “Controlled” group will not receive a new treatment, but they are going to obtain a similar treatment. There are limitations regarding this method because the sample size comparing to the population is inaccurate and the data is not consistent with real-world clinical practices. Real-World Evidence (RWE) and RCT are complementary to each other, however, Real-World Data (RWD) progresses beyond RCT. Real-World Data are collected from both internal and external sources. Comparing to RCT, RWD are diverse and contains a broad range of data. Real-World Data is based on:

  • Electronic health records (EHRs)
  • Insurance billing and claims
  • Disease or registering medication or devices
  • Patient-reported outcomes
  • Biometric monitoring devices

China Targeting on Real-World Evidence 

China’s Center for Drug Evaluation disclosed a draft on “Key Considerations in Using Real-World Evidence to Support Drug Development” for the public to examine. The deadline for examination is 3 months and the draft if available in both Chinese and English on the CDE website. There are five parts in the draft:

  1. Introduction (background and purpose of using RWE to support drug development)
  2. The Definition and Scope of Real-World Evidence on a Conceptual Level (relevant definitions of Real-World Search)
  3. Scenarios Where Real-World Evidence Supports Drug Development and Regulatory Decisions
  4. The Basics of Real-World Research Design (clinical trials and observation studies)
  5. Evaluation of Real-World Evidence (whether it can answer scientific questions and be scientifically analyzed)

In part three of the draft, the six scenarios described are:

  1. Treatment for rare diseases
  2. Revision of indications or drug combination labeling
  3. Post-marketing evaluation
  4. Clinical development of traditional Chinese medicine hospital preparations
  5. Guiding clinical trial design
  6. Identify the target population

Reference

An Important Step for RWE in China: China CDE Published the Draft Key Considerations in Using Real-World Evidence to Support Drug Development. (2019, June 12). Retrieved February 28, 2020, from https://www.accestra.com/2019/06/12/an-important-step-for-rwe-in-china-china-cde-published-the-draft-key-considerations-in-using-real-world-evidence-to-support-drug-development/

Commissioner, O. of the. (2019, May 9). Real-World Evidence. Retrieved February 28, 2020, from https://www.fda.gov/science-research/science-and-research-special-topics/real-world-evidence

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