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IBM tool reduces time and cost for clinical trials

Steve Rogerson
February 25, 2020

At this month’s Scope Annual Summit for Clinical Ops Executives in Florida, IBM Watson Health unveiled a cloud-based data-driven, study design tool designed to optimise clinical trial protocol design.
The tool merges automated access to real-world patient population data, standardising protocol template guidance and providing a collaborative workspace designed to facilitate efficiency.
On average, a single protocol amendment to a phase III clinical trial can result in approximately $500,000 in unplanned expenses and an additional 61 days to the project timeline.
IBM Study Advance is designed to offer critical insights during the process of study design to help reduce the number of amendments during clinical trials. The tool is designed with an interface to provide access to commercial and claims data from de-identified patient profiles covering 89 million lives from multiple employer-sponsored US healthcare beneficiaries, as well as tools to assess the impact of inclusion and exclusion criteria on the eligible patient population.
"Currently, 80% of trials experience delays in recruiting and one out of four amendments were considered completely avoidable," said Rob DiCicco, deputy chief health officer for IBM Watson Health. "Breakdowns in the clinical trial process, including issues caused by study design decisions, may potentially delay access to life-changing therapies for patients. IBM Study Advance aims to remove the barriers in clinical development to help researchers efficiently bring necessary therapies to patients."
Study Advance's collaborative workspace is designed to allow near real-time collaboration with study design team members who can manage and assign the team to specific sections of the protocol. The workspace is also designed to provide access to standard protocol templates and version control capabilities with complete traceability back to changes, aiming to reduce the average time required to author a clinical trial protocol.
Also at Scope, ConvergeHealth by Deloitte announced MyPath for Clinical, a cloud-based digital platform designed to enhance the patient experience as well as the success and efficiency of global clinical trials. The modular, patient-centric platform can help accelerate the execution of digital clinical trials by taking a holistic approach to connect clinical trial participants, investigators and clinical research associates.
It leverages modern cloud, mobile and connected medical device technologies to address the three core industry challenges of patient recruitment, patient engagement to drive retention and protocol management.