Appropriate Recruitment
The success of a trial may depend on clinical teams across multiple sites accommodating complex sets of eligibility criteria—lists of variable exclusion and inclusion standards that must be met before a patient begins a new treatment. Gaps in communication together with cumbersome processes may cause inappropriate recruitment, which can result in the halt of a clinical study and endanger viable results. Life Sciences processes require extensive data to flow between stakeholders, participants, and decision-makers. A lack of transparency in the data flow and an inability to quickly address inefficiencies inhibits the speed of decision-making. This increases the duration and cost of clinical trials and delays the delivery of vital new therapies that improve lives of patients.
The Problem
A United States-based biotechnology company required a unique combined solution for a pivotal clinical trial to test the safety and efficacy of a novel immunotherapy designed to treat refractory or recurring Multiple Myeloma. The American Cancer Society estimates that in 2024 in the U.S., over 35,000 new cases of Multiple Myeloma will be diagnosed. Worldwide, more than 100,000 people die of this progressive form of cancer each year. Although recent advances in treatment options are improving the lives of patients, Multiple Myeloma is still considered an incurable cancer. The success of the sponsor’s trial will provide a new treatment option that significantly extends lives of people with Multiple Myeloma worldwide.
The Situation
The CRO and trial sponsor selected Judi in Eligibility for its 100% configurable workflow, real-time communication, and ability to facilitate a patient screening process with complex criteria of eligibility review, combined with quality control of dossier and forms, and customized automated notifications to radiologist and pathologist reviewers—dependent on the uploaded document type. The sponsor and CRO added Judi in Adjudication for its best-in-class adjudication of clinical data, real-time collaboration and query generation, de-identification of DICOM data, including PET and CT scans; event tracking, and organized reporting—over 600 endpoints, multiple sites, and over 100 patients.
Enhanced Collaboration
Employing AG Mednet’s CORE principals—Client Centricity, Orchestrated Collaboration, Robust Simplicity, and Efficient and Secure Workflows, Judi helps clinical trial teams around the world come together to seamlessly manage complex interactions and insights, allowing them to do their best work, faster.
Along with a fast and secure adjudication workflow, the Judi platform provided an efficient way for the biotech sponsor and partner CRO to manage complex patient eligibility review, including automated customized notifications to radiology and pathology teams, depending on the type of document uploaded at sites. Moreover, after the trial was live, the sponsor realized it needed to add an additional form paired with custom notifications to determine patient eligibility more efficiently. Because Judi is fully configured to meet the needs of the sponsor’s workflows, the live trial was adjusted without losing patient eligibility or adding weeks to the trial. The purpose-built, cloud-based Judi Collaboration Platform saved the sponsor significant time and expense, and loss of vital patient data.
