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Achieving Meaningful Subgroup Data In Clinical Trial Design and Development: Scientific Considerations and Approaches Workshop

January 27, 2016 @ 8:00 am - January 28, 2016 @ 5:00 pm

Click here to download the meeting outputs.



DATE: January 27-28, 2016

LOCATION: Biotechnology Industry Organization Office
1201 Maryland Ave., SW, Ste. 900, Washington, D.C. 20024

ABOUT: An interactive workshop to share perspectives on key issues in drug development related to meaningful subgroup inclusion in clinical trials. Please note that participation in this event is by invitation only. 

Clinical trials that appropriately reflect the population at risk for a disease is the key to providing meaningful information to patients and healthcare providers on the use of medications.

Participants will include broad representation from clinical trials ecosystem. Dialogue will help advance a scientific framework for better understanding the drivers of variability in response to medicines amongst demographic subgroups; identify relevant opportunities to improve the drug development and approval processes; and improve communication to patients and healthcare providers.


This session will produce tangible feedback (e.g. white papers, meeting summaries) to share with the FDA, the broader clinical trials ecosystem, including:

  • Key takeaways from workshop discussions, noting points of alignment and disagreement
  • Identification of key questions for research by FDA and other stakeholders
  • Specific recommendations for additional regulatory guidance or policies; if and where participants have significant alignment around a position

*Note: Any summaries presented to the FDA and others will be on behalf of individual participants, not necessarily the organizations they represent.

This workshop will be a valuable step to advance the science of drug development, and utilize new regulatory tools and modern approaches to improve or change existing processes in service of patients.


Participants will be engaged in discussions on the following topics areas:

Topic 1: Variability in Drug Responses in Different Demographic Subgroups

How can we best determine:

  1. When differences in response to drugs are biologically plausible?
  2. What thresholds of plausibility should trigger the investigation of the apparent differences?
  3. How can these concepts be incorporated throughout the development process?

Topic 2: Innovative Tools & Methodologies

What science-based tools and methodologies (e.g., novel statistical analyses, dose-response computational models, adaptive clinical trial designs) could be used to effectively investigate variability of drug responses during: 

  1. Study design, 
  2. Analysis, and         
  3. Drug development?

Topic 3: Stakeholder, Patient, & Healthcare Provider Communications

How well does FDA’s posting of demographic information from pivotal clinical studies (Drug Trials Snapshots):

  1. Improve access to data describing demographic subgroups? 
  2. Increase stakeholders’ understanding of whether subgroup analyses included in clinical research data have resulted in clinically meaningful findings?


  • Theresa Devins, DrPH, MS, Senior Associate Director, Clinical Trial Management, Boehringer-Ingelheim Pharmaceuticals, Inc.
  • Rachael Fones, Director, Government & Public Affairs, Quintiles
  • Eldrin Lewis, MD, MPH, Associate Professor, Harvard Medical School
  • Monica Mallampalli, PhD, MSc., Vice President, Scientific Affairs, SWHR
  • Scott McGoohan, JD, Director, Science & Regulatory Affairs, BIO
  • Leslie Ritter, MA, Vice President, Public Policy, SWHR
  • Jocelyn Ulrich, MPH, RAC, Senior Director, Scientific & Regulatory Affairs, PhRMA
  • Dhananjay Vaidya, PhD, Associate Professor of Medicine, Johns Hopkins School of Medicine



















SWHR invites you to take advantage of our sponsoring opportunities. If you are interested in sponsoring the workshop, please contact Paris L.A. Moore by email at paris@swhr.org.

Sponsorship of this workshop does not imply agreement with any content and/or comments presented by the faculty during the workshop proceedings.


For questions regarding the workshop, please contact: science@swhr.org.


January 27, 2016 @ 8:00 am
January 28, 2016 @ 5:00 pm
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