We Are DIA

2018 Community Grand Challenges Winners


IA has invited Community members to submit suggestions for their Community’s number one top priority problem to help identify the most important challenges within each of the areas represented in our DIA Communities. These suggestions were then selected as the Community’s DIA Grand Challenge Topic for the year.

Community members worked individually or as part of a team on proposing solutions to these Grand Challenge topics. Their submitted solutions were judged by a panel of peer-reviewers with expertise in the various topic areas.

Congratulations to the winners of this year’s competition!

Clinical Research Community

Grand Challenge Topic: Moving Beyond Next Generation Clinical Trials: How Can We Develop More Efficient Ways to Get New Drugs to Patients Sooner?

Submission Title: PROMs: An Underutilized Tool in Orphan Drug Development, and a Proposal to Increase Use

Proposed Solution: In order to improve the drug development process for rare and orphan diseases, this team proposed the creation of a regulatory guidance document that builds on existing patient-reported outcomes (PROM) guidances from the FDA and EMA, but focuses on a rare disease PROM as a primary endpoint to support marketing approval.

Stay tuned for details coming up in future issues of Global Forum.

Samantha Miller
Registry/Program Coordinator, University of Pennsylvania Orphan Disease Center

Suzanne Thornton-Jones
Executive Director, Regulatory Affairs and Compliance, University of Pennsylvania, Perelman School of Medicine, Gene Therapy Program

Clinical Safety and Pharmacovigilance Community

Grand Challenge Topic: Implementing Artificial Intelligence/Machine Learning into Pharmacovigilance

Submission Title: Proposed Guidelines for AI Implementation in Pharmacovigilance

Proposed Solution: This community member proposed a set of best practices on how to most effectively implement artificial intelligence and machine learning solutions in the drug safety and pharmacovigilance workflows to maximize the accuracy and efficiency of the processes involved in these areas.

Stay tuned for details coming up in future issues of Global Forum.

Brittany Gerald
Founder and CEO, MobiDox Health Technologies

Statistics Community

Grand Challenge Topic: Getting the Question Right: How Can We Foster Better Engagement and Collaboration Across Communities, Roles, and Areas of Expertise to Help Us Generate Better Estimands?

Submission Title: Getting the Questions Right Webinar Series on Estimands

Proposed Solution: This team developed a new paradigm to enhance collaboration between statisticians and others engaged in clinical trials called “Getting the Questions Right” (GTQR). The goal of the GTQR effort is to create discussions among these stakeholders to promote a better understanding of what estimands are, how to begin using them, and how they matter to science and patients.

Stay tuned for details coming up in future issues of Global Forum.

Joan Buenconsejo
Senior Director, BiometricsTeam

Jürgen Kübler
Owner, Quantitative Scientific Consulting

Matt Baldwin,
Senior Biostatistician, PRA Health Sciences, Strategic Solutions Division, Janssen Pharmaceuticals, Inc.