P38: Impact of A Cloud-Based Clinical Data Management System on COVID-19 Trials: Rapid Operationalization of a Remote Approach
Deputy Chief Science Officer
IBM Watson Health United States
The objective of this study is to evaluate a cloud-based clinical data management system’s (CDMS) functionality, robustness, and impact on clinical trial efficiency and conduct during the COVID-19 pandemic, especially with increased reliance on remote work and adaptive trial design.
A combination of web-based surveys and semi-structured interviews of clinical trial data managers and review of operational results were used to assess the ability of CDMS features to increase efficiency in clinical trial data management and to support fast-tracking of COVID-19 trials.
To enable rapid operationalization of COVID-19 clinical trials, IBM Clinical Development (ICD), a unified, cloud-based CDMS platform, was offered free-of-charge to pharmaceutical companies and contract research organizations (CROs). ICD is designed to provide end-to-end trial execution support as well as patient, site, and clinical trial management capabilities. ICD was offered for a maximum of 18 months with an effective date no later than July 1, 2020 and an end date no later than December 31, 2021. Accepted trials were characterized by applicant, trial and intervention type, and geography. From March 1st to July 1st, 2020 IBM received 83 applications and accepted 69 trials (51 from CROs and 18 from sponsoring organizations) based on the stipulated criteria. Sixty-eight trials were interventional, and one was observational. Therapies included eight vaccines, 54 drugs, and 7 other. Locations included North America (55), South America (7), Europe (3), and Australia (4). Results indicated the average time to design and release the study database for a COVID-19 trial was 13 days, as compared to an industry benchmark of 68 days for a non-COVID-19 trial (PMID 29714600). Factors found to be important in the rapid execution of trials included an end-to-end solution with multiple embedded functionalities built on a single code base and featuring randomization, end-point adjudication, electronic clinical outcome assessment and medical coding within one unified platform. CDMS compartmentalization facilitated the study launch and enabled database splitting, which allowed parallel processing of downstream workflows, further accelerating study start-up. Flexibility of the platform enabled facile mid-study updates to accommodate adaptive COVID-19 trial design. Quick data migration from discrete external sources in configuring and harmonizing data within a CDMS was found to be important.
The novel and deadly COVID-19 pandemic has necessitated rapid development and testing of vaccines and therapies. From first discovery, the average time to take a new drug or vaccine to market can range from 10 to 15 years with over half of that time spent on clinical trials alone. However, the urgency of the current global pandemic has warranted resetting the clinical trial clock to mitigate morbidity, mortality, and economic collapse. Accordingly, efficient CDMS have become critical for accelerated operationalization of clinical trials, especially important when dealing with a largely remote workforce.
The ability to integrate data from third party sources enabled rapid study reporting. The platform, with a single code base, permits study teams to deploy modules in stages, accelerating study initiation and minimizing delays related to post-go live changes, amendments, and mid-study updates, without compromising quality. The flexibility and customization of the CDMS were essential to the adaptive clinical trial response to mid-study updates and post-go-live protocol amendments. Due to the agility of the CDMS, patient enrollment and data entry prior to and during the pandemic occurred without disruption, enabling fast-tracking of COVID-19 clinical trials.
The COVID-19 global health emergency prompted unprecedented collaboration across healthcare organizations and industry. Free access to IBM’s CDMS platform enabled sponsors and CROs to significantly minimize COVID-19 trial start-up time and accommodated adaptive trial design, while empowering efficient remote work. The pandemic has demonstrated the collective sense of urgency and collaboration among healthcare information technology companies, CROs, and sponsors in striving to bring effective therapies to benefit humanity.