Session 25 - Increasing importance of Clinical Outcomes Assessments - Is DM Ready to Deal with it?

  • #pioneer
Wednesday, September 16, 2020: 10:15 AM - 11:15 PM
/ CEU Credits:0.2


Session Chair
Arshad Mohammed
Deepu Joseph
VP and Global Head of DM
Quanticate International
Jeff Beeler
Executive Director, Solutions Enabling, Connected Care
PRA Health Sciences
Chair & Speakers
Poulamee Pande
Manager, Clinical Data Management
Tanya du Plessis
VP, Data Strategies and Solutions


Clinical Outcomes Assessments (COAs) data is being increasingly recognized by clinicians and regulators as a valuable tool to collect patient-centered data. COAs including Patient-reported outcomes (PROs) are commonly collected in clinical trials, often included as primary or secondary endpoints. PROs assess a range of outcomes including symptoms, functional health, well-being and psychological issues from the patients' point of view. COAs, provide significant information on the impact of a health condition and its treatment from the patient's perspective increasingly being included in clinical trials to ensure that the impact of trial intervention is fully assessed. COAs, traditionally have been managed externally as a third-party data source, and there has not been a focus on DM related to systems, data collection, and processes around them. In this panel, we will discuss:

  • How COA endpoints have added value to clinical trials;
  • Problems with current practices in designing, implementing, and reporting COA;
  • studies and solutions to address, including DM's role on CDM planning, design, development, conduct, closeout and archival;
  • Technological improvements and device/sensor integrations to enable better COA data collection;
  • Avoiding missing PRO data - integration of COA data - how much?
  • Regulatory viewpoints on COA data and role of DM an exploration of the future and - is data management team ready for more?



1. Participants will be able to learn about eCOA and their types
2. Participants will appreciate the type of data expected from eCOA and similar technologies and solutions
3. Participants will understand the approach to planning, designing, managing and reporting on such data and patient engagement
4. Participants will learn about regulatory position on such data and also where is this going in the future


CDM Certification Competencies::
Clinical Trials Processes, Roles, and Responsibilities,Data Management Plans,Processing External Data

Target Audience:
DM Management,Programmer,Clinical Data Manager