Agenda – 2nd Real-World Evidence Forum

Real-World Evidence Forum
The Agenda is currently under development

Topics under consideration:

Data Collection

  • Refining the outcomes by feeding patient information back to development groups to evaluate endpoints
  • Address the lack of standard universal data and how it presents a challenge in the effective analysis of Real World Data
  • Optimize bottlenecks to reduce the time between receiving data and preparing it for final research and analysis
  • Linking datasets (pharmacy claims, electronic medical records, laboratory data, social media and work habit demographics)
  • Building a platform
  • Using small-data sets instead of building out big data
  • Collection of better data

Safety

  • Safety vs. Marketing (public health and industry health)
  • Use RWD to identify a drugs usefulness and adverse events
  • Developing models to predict probability of events so that corrective measures can be taken

Regulations

  • Opportunities and challenges for generating industry-wide standardizations
  • Understanding regulatory framework in the US and worldwide
  • Having an awareness of regulatory and compliance safeguards to minimize risk
  • Identify regulatory contact points for help with trial approval
  • Identify submission elements for trial approval
  • Aggregate and submit the necessary pre-market data
  • Comply with necessary ongoing reporting, auditing, and monitoring requirements
  • EU vs. US regulation

Trial Design and Protocol

  • Determine the right type of post-market study
  • Application of late-stage protocol
  • Early planning of a drug’s approval
  • Site and patient retention
  • Bridging the gap between clinical data and commercial data

mHealth

  • Using technology for data collection
  • The growing use of EHRs
  • Virtual trials
  • Mobile tools supporting the development portfolio
  • Develop easier ways for patients to get information to their doctors

Establishing the right partnerships

  • Balancing scientific and commercial values of non-interventional studies
  • Utilize pharmacists and doctors for data collection
  • Supporting clinical trial success with RWE investments
  • Harnesses RWD before approving new and expensive treatments

Patient Centric Approaches

  • Understand the new types of options and strategies such as social media and electronic medical records
  • Identify challenges of patient recruitment and retention for observational studies
  • The advantages of patient recruitment using a centralized investigator, direct-to-patient (though the pharmacist) model
  • New ways to engage with and pre-screen patients through their pharmacist

Megan Heburn
T: 212-400-6230
mheburn@exlevents.com
494 8th Avenue, 4th Floor New York, NY 10001