The COVID-19 pandemic has accelerated the clinical trial community’s quest to streamline its data-driven processes in order to find new and better ways to gain flexibility and efficiency throughout the clinical development continuum.
Veristat’s Ryad Ramda and Cindy Henderson were among the authors of a study whose findings were published in a recent article appearing in Applied Clinical Trials titled, Accelerating Clinical Trial Design and Operations. The study examined how a clinical data management system (CDMS) enabled trial data management during two COVID-19 trials and outlined the effect of a CDMS on trial design and implementation efficiency.
The timeliness of this topic is apparent as we continue to grapple with the development and administration of the ideal complement of vaccines and therapies for a diverse set of COVID-afflicted patient populations. And for those whose responsibility it is to preserve, protect, and defend the quality of trial data, the assurance of a high-quality statistically sound final database lock becomes that much more challenging as the volume and complexity of trial data grows.
Evaluating the Effect of a CDMS: Study Methodology and Approach
As outlined in the article, two clinical trials were used to assess the overall contributions of the CDMS:
- Therapeutic drug trial: a Phase II open label, randomized control, proof-of-concept study of 50 patients hospitalized with COVID-19 in eight US sites
- Vaccine trial: a Phase I open-label, non-randomized study evaluating the safety, tolerability, and immunogenicity of 120 healthy volunteers in three US sites
Specifically, investigators explored how the CDMS— the IBM Clinical Development (ICD) — was used based upon Veristat’s experiences during the pandemic to pinpoint any potential impact on clinical trial efficiency and/or the usability and workflow of the CDMS. Factors that were examined included:
- data management processes
- how the CDMS supported an optimized workflow in trials conducted during the pandemic and through phases of remote work
- data management challenges either specific to or exacerbated by the COVID-19 pandemic
- measured assessments on usability, acceptability, and satisfaction
Both retrospective and prospective internal usage and administrative IBM CDMS data were analyzed at the project level for each clinical trial. Internal data from usage reports included:
- dates for key data management events (e.g., database release and lock)
- module usage
- mid-study updates
- database downtime
To supplement the aggregated ICD usage data, Veristat provided additional operational and study management metrics to assist in the evaluation of:
- database build efficiency (cycle time to design and release the study database in the CDMS*)
- velocity of data collection (the number of data points collected over time after the database was released)
- frequency of protocol amendments on the database
- time impact of mid-study updates to the database
*The average cycle time to build COVID-19 study databases was compared to both Veristat’s and published industry baselines prior to the pandemic to establish study efficiency.
Data collection devices included assessment forms, attitudinal surveys, and online video interviews with lead data managers and IBM CDMS users from each clinical trial to bring to surface those challenges unique within their clinical trial.
The unforgiving nature of COVID-19 trials require technologies that support accelerated deadlines, complex processes, and regular mid-study changes. Against all measures, the CDMS drove higher flexibility and efficiency throughout the studies as highlighted below:
- The average time to design and release the study database was 11 business days for the COVID-19 trial, an impressive 63.3-72.5% reduction compared to Veristat’s typical 30-40 day timeline and an 83.9% reduction compared to an industry benchmark of 68.3 days for a non-COVID trial.1
- Both trials had three mid-study updates during the evaluation period. On average, the database was only locked for less than one hour per mid-study update in each trial.
- 100% of participants stated that the CDMS either somewhat or very much saved time for study startup, data collection, and study closeout.
- 100% of survey respondents agreed or strongly agreed that the IBM CDMS integrated with workflow, increased productivity, was interoperable and easy to set up and start up.
- 100% thought the CDMS somewhat or quite a bit helped to avoid cost, reduce manual errors, and decrease delays from mid-study updates.
- 75% believed the CDMS was flexible and customizable and reduced manual errors.
- Responses from interviews brought to surface two key factors that supported the efficient launch of study databases: first, easy code reuse for database creation; second, minimal to no downtime when executing mid-study updates or post-go live changes, speeding up trial start dates and protocol amendments, and allowing for adaptive COVID-19 trial design.
Optimizing for a More Efficient Tomorrow
Clinical trials are anything but simple, especially in our post-COVID world. This study demonstrated that an integral component of accelerating the clinical trial timeline is deployment of an efficient CDMS. Utilization of an end-to-end solution, like IBM CDMS with multiple embedded functionalities built on a single code base including randomization, endpoint adjudication, electronic clinical outcome assessment, inventory management and medical coding on one platform helped to facilitate the rapid execution of each trial. The IBM CDMS also enabled seamless transition to remote work during the pandemic without disruption to data entry and patient enrollment.
Veristat works in lockstep with clients as we rise to the challenge together in implementing studies in unprecedented time, redefining what it means to be flexible and efficient. As we adapt our data-driven processes and optimize our CDMS technologies to deliver greater value, we are steadfast in our commitment to help bring much needed COVID-19 vaccines and therapies to market on a global scale.
Read the full article here.
- Support for COVID-19 Vaccine, Diagnostic and Treatment Programs here
- Read the case study: Rapid Launch of a COVID-19 Phase I Vaccine Trial
- Learn about our Clinical Trial Data Management Solutions here
1 Wilkinson M, Young R, Harper B, Machion B, Getz K. Baseline Assessment of the Evolving 2017 eClinical Landscape. Ther Innov Regul Sci. 2019 Jan;53(1):71-80. doi: 10.1177/2168479018769292. Epub 2018 Apr 26. PMID: 29714600.