In the world of clinical trials, we mustn’t lose sight that the patient is at the center of what we do. Patients are invested in sharing their disease experience and in giving their time and energy to help inform new treatments. As a result, the importance of capturing the patient voice in clinical trials has paved the way for adoption of eCOA. In today’s technologically advanced world, cutting edge technology and rapid study build are very much at the forefront of the eCOA industry. An eCOA solution will only be as robust as the scientific strategy that it is built upon. Marrying scientific strategy with eCOA implementation is key to building a successful study and minimizing patient burden.

Join IQVIA experts Melissa Mooney and Stephanie Philpott to explore the role of the scientific strategy within your eCOA implementation.

Topics covered include:

• Considerations needed during endpoint development and COA strategy creation
• Successful eCOA implementation techniques
• Technical and Scientific considerations for paper to electronic migration

Attendees will learn how to:

• Minimize patient burden via a COA strategy and eCOA design
• Confirm that your eCOA implementation and scientific strategy are working in tandem
• Implement faithful migration best practice recommendations

Speakers:

Melissa Mooney
Director, eCOA Solutions Engineering, eCOA Technologies
IQVIA

Stephanie Philpott
Scientific Manager, Patient Centered Solutions, Real World Solutions
IQVIA

Clinical Outcomes Assessments (COA / eCOA) are an accepted component of clinical research; however, a one size fits all approach when it comes to aligning the eCOA strategy to the trial objectives is not a robust approach and the eCOA strategy needs to be aligned with the specific patient population and the desired clinical differences that are being assessed. As clinical research adapts to the needs of the Oncology and Rare disease space, a change is required to ensure that the eCOA strategy is fit for purpose and meets the needs of both the patient as well as the study objectives.

In this talk we will discuss:

• Why eCOA is an important part of your trial design
• Why Patient insights are key to both trials design and your eCOA strategy
• Why it is important to ensure that the right eCOA are selected for your study population by identifying the unique challenges of Rare disease and oncology patient populations
• Highlight the lessons learned from Covid and how we can define a new norm for research which puts the participants at the center
• How your eCOA strategy needs to focus on the global perspective and to ensure inclusivity
• Why it is important to monitor your eCOA compliance and identify triggers early so that sites can be active partners in the study

Speaker:

Chris Watson
Director, Consulting
THREAD Research

• Optimizing electronic capture of clinical outcome assessment data in clinical trials: the case of patient-reported endpoints
• Considerations for requiring subjects to provide a response to electronic patient-reported outcome instruments
• “Bring your own device” (BYOD): the future of field-based patient-reported outcome data collection in clinical trials?
• Establishing equivalence of electronic clinician-reported outcome measures
• Selection of and evidentiary considerations for wearables devices
• Best or recommended practices from the clinical trials transformation initiative, drug information association initiatives, and electronic clinical outcome assessment consortium

Speaker:

Joseph Cappelleri
Executive Director of Biostatistics
Pfizer Inc

Many clinical trial sponsors and CROs are still on a quest for the perfect, one-size-fits-all solution for eCOA and patient engagement. Instead, sponsors and CROs should be seeking a partner whose solution is offers maximum flexibility. But what does that look like in a modern clinical trial? In this session, we’ll explore how the right solution aligns not only to your workflows but also with your trial. And how you can apply a nuanced approach to trial design and execution for certain indications, ensuring the ability to expertly tailor every component of the trial solution.

Speaker:

Kyle Hogan
President
Datacubed Health

The eCOA/ePRO is directly collected from subjects, requiring sponsors to monitor the data quality and have appropriate quality gates to ensure the data integrity. The session will provide details on Abbvie’s data monitoring approach for eCOA data and best practices around this capability

Speakers:

Nikala Kwech
eCOA & Digital Operations Manager, Clinical Data Strategy & Operations
AbbVie

Aman Thukral
Director, Systems and Digital Operations, Clinical Data Strategy & Operations
AbbVie