SCOPE Preview: Patient Engagement, Real World Data, And Biomarkers In Clinical Trials

December 21, 2017 | Clinical Informatics News will be attending the Summit for Clinical Ops Executives*—SCOPE—in Orlando, Fla. from February 12-15, 2018. Over those three days we are looking to seeing the challenges, solutions, and advances facing clinical trials. SCOPE covers a wide range of content covering 18 different conferences, 3 plenary keynote sessions, and the ever-popular interactive breakout discussions focused on advances and innovative solutions in all aspects of clinical trial planning, management, and operations. Here are just a few of the items from the agenda we’ve flagged so far.

--The Editors


Shwen Gwee of Biogen will kick off the summit’s keynote sessions by covering three easy steps that are used by MIT Hacking Medicine, a student organization that runs health hackathons around the world, to help hack innovative solutions for medicine and healthcare. The approach draws principles and learnings from Design Thinking, Lean Startup, and other innovation processes, which when applied to your organization or corporate approach, can help you hack your way to creative, valuable solutions that can engender value and drive true innovation.

Harnessing the power of collaboration can alter the healthcare landscape as we know it today. This session, lead by Robert DiCicco of GlaxoSmithKline, will bring together a diverse panel representing some of the industry’s most influential organizations for a candid and innovative conversation about what is needed to shake up the current ecosystem and truly transform patient health. This panel discussion will address: What is working today, and how will the ‘next generation of collaborations’ be different? Is collaborative R&D, pooling data and insights from academia, sponsors, and CROs in our near future? What roles will FDA, consortiums, technology providers, and other stakeholders play?

The presentations of the Fifth Annual Clinical Informatics News Best Practices Awards and SCOPE’s 2018 Participant Engagement Award will take place during the keynote sessions as well. The Best Practices Awards program seeks to recognize outstanding examples of applied strategic innovation—partnerships, deployments, and collaborations that manifestly improve the clinical trial process. The Participant Engagement Award recognizes innovation and change in how the industry communicates with participants in the fields of recruitment and retention in clinical trials.

The Clinical Data Strategy and Analytics track features several sessions bringing together clinical research informatics experts to discuss the challenges and find solutions necessary to navigate and thrive in the clinical research industry and healthcare IT’s rapidly changing environment. Ken Getz of Tufts Center for the Study of Drug Development and Richard Young of Veeva Systems will present new research from Tufts Center for the Study of Drug Development on current and evolving EDC practices across the drug development enterprise.

The inaugural Sensors, Wearables and Digital Biomarkers in Clinical Trials track will be looking at how the clinical research industry is moving toward end-to-end digital clinical trials. Amir Lahav of Pfizer will provide an approach to developing and validating digital biomarkers using remote health monitoring of daily activities. Aman Thukral of AbbVie will discuss key considerations in integrating wearables/sensors data in a clinical trial sponsor’s ecosystem.

During the Patient Engagement, Enrollment and Retention through Communities and Technology track, session leaders will cover the topics one should consider when planning and strategically implementing a patient retention plan in the digital age. Therese Johnsen of Novartis will discuss how companies and vendors protecting the patient information gathered during engagement activities is a rarely studied topic. Hassan Kadhim of Boehringer Ingelheim Pharmaceuticals will discuss qualitative and quantitative research conducted by the Clinical Trials Transformation Initiative to understand the perspectives of patients and site investigators of mobile clinical trials.

Managing Outsourced Clinical Trials will feature case studies and lessons learned from sponsors and CROs on vendor quality and performance in light of the new ICHE6 R2 changes, as well as the outsourcing partnership and working with third party suppliers to achieve more efficient clinical trials. Sagarika Bollini of Bristol-Myers Squibb will discuss key components to CRO/sponsor relationship management and building a framework of trust within the partnership. Marija Nikolic of Astellas Pharma Global Development will focus on how to go about understanding the true business levers and drivers to make meaningful supplier segmentation.

The Leveraging Real World Data for Clinical and Observational Research track will feature sessions and discussions centered on challenges and solutions with secondary use of existing healthcare data for assessing the effectiveness and safety of medical products. Jane Fang of AstraZeneca will present on how the innovative approach of linking RWE analysis with clinical trial research and patient recruitment is critical for today and future precision trial conduct. Sean Mooney will discuss the University of Washington’s efforts to leverage data and IT platforms to support research activities throughout the enterprise.

*The Advanced Registration deadline for SCOPE ends January 5, 2018. Register here for your chance to save up to $200.


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