Use of External Controls for Oncology RWE Studies to Enhance Development and Accelerate Knowledge of New Treatments

August 12, 2021

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Open to all ISPOR Members and Non-members


Presented by:

  • Sarah A. Alwardt
  • Nicholas Robert
  • Robert L. Coleman
  • Janet Espirito
  • Marley Boyd

August 12, 2021
2:00PM EDT | 7:00PM BST | 8:00PM CEST 

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Study designs utilizing external control arms have been suggested as a methodological approach to be able to efficiently assess outcomes in oncology studies using real-world and observational evidence. Although randomized control trials (RCTs) are considered the gold standard, you will hear from physicians, clinical trialists, statisticians and other real-world research experts on their perspective of current and future applications of synthetic controls to enhance development and increase knowledge of new oncology treatments. They will address challenges faced by the pharmaceutical industry with clinical trials and the potential benefits that may be addressed with external controls, including lower costs, increased efficiency, time savings and potential ways to introduce real-world data elements for regulatory decisions. Our experts will address:

1. What are External Control studies? How are they designed? And how are they beneficial in clinical development to biopharma?
2. Clarifying industry “definitions” surrounding external controls
3. Addressing challenges with the eligibility criteria of oncology clinical trials
4. Considerations of using real-world data for oncology external control studies
5. Describe previous use cases and potential future uses and applications 

Learning Objectives:

  • Defining an external control study design
  • Identify challenges with eligibility criteria of oncology clinical trials
  • Considerations of using RWE for oncology external control studies
  • Understanding potential future uses and applications for external controls

Register Here

Sponsored by: Ontada 


Sarah A. Alwardt,
PhD, Vice President, Real World Research, Ontada, Texas, USA

Nicholas Robert, MD, Vice President, Medical Affairs, Ontada, Texas, USA

Robert L. Coleman, MD, Chief Scientific Officer, The US Oncology Network, Texas, USA

Janet Espirito, PharmDDirector of Real World Research, Ontada, Washington, USA

Marley Boyd, MS, Research Manager, Real World Research, Ontada, Texas, USA

Please note: On the day of the scheduled webinar, the first 1000 registered participants will be accepted into the webinar. For those who are unable to attend, or would like to review the webinar at a later date, the full-length webinar recording will be made available at the ISPOR Educational Webinar Series webpage approximately 2 days after the scheduled Webinar.

Reservations are on a first-come, first-served basis.

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