Good Morning Meeting | Promise and Perils of Subgroup Analysis in Early Drug Development

June 21, 2023

Copenhagen, Denmark

We are pleased to invite you to the IDDI & MVA complimentary meeting to explore the advantages & challenges of subgroup analysis in early drug development.

Wednesday, June 21  |  9am – 11am CEST    
Medicon Valley Alliance, Arne Jacobsens Allé 15, 2300 Copenhagen S, Denmark – Meeting room: Auditorium

Defining patient subgroups more likely to benefit from novel treatments is an increasing imperative in this era of precision medicine. Moreover, an increasingly competitive market space provides further incentive for defining such patient subgroups. Predictive biomarkers play a key role in creating and assessing subgroups, and the very definition of a predictive biomarker is predicated on subgroup analyses demonstrating a statistical interaction between the biomarker level and the treatment effect. Thus, subgroup analyses now play a larger role in drug development, and arguably in earlier stages than in the past.

Early definition of subgroups more likely to benefit often becomes a crossroads leading to higher chance of success and a swifter development if the right subgroup is chosen, but the alternative road entails greater safety by postponing these early choices, albeit at the cost of a slower development. Unfortunately, the well-known risks of false-positive and false-negative findings from subgroup analyses in phase 3 trials are compounded by smaller samples sizes, uncertainties about the analytic performance of the biomarker, and the fact that early-phase trials are often plagued by the phenomenon of “regression to the mean”.

In this presentation, we will attempt to outline the key aspects that need to be taken into account when looking at subgroups in early development. This can hopefully allow for more informed decisions and explicit understanding of potential trade-offs between choices. The main examples will come from the oncology space, but the concepts discussed are applicable to any other indication where precision medicine is of interest.

KEY LEARNING OBJECTIVES:

• Central aspects of subgroup analysis in early drug development
• Potential trade-offs associated with defining patient subgroups

AGENDA:

• 09:00 Networking, registration and light breakfast
• 09:30 Welcome
  David Munis Zepernick, Director, Member Engagement & Communication, Medicon Valley Alliance
  Erik Falvey, Senior Director Business Development Europe, International Drug Development Institute
• 09:35 Promise and Perils of Subgroup Analysis in Early Drug Development
  Everardo D. Saad, MD, Medical Director, International Drug Development Institute
• 10:20 Q&A
• 10:30 Networking
• 11:00 End of Good Morning Meeting

SPEAKER:

Everardo D. Saad, MD, Medical Director, International Drug Development Institute (IDDI)
Dr. Everardo Saad has nearly 20 years of experience in Medical Oncology and clinical-trial design. He graduated in Medicine and trained in Internal Medicine in Sao Paulo, and did his fellowship in Medical Oncology at the University of Texas M.D. Anderson Cancer Center, in Houston. After practicing for several years, he shifted his professional career towards education and research in Medical Oncology, and has a special interest in clinical trial methodology, the assessment of endpoints, and the development of novel therapies for cancer patients.