RESTON, Va.--(EON: Enhanced Online News)--Aptiv Solutions, a global biopharmaceutical and medical device development services company and leader in adaptive clinical trials, today announced the integration of 'Verification by Statistical Sampling' into AptivInSite™ to improve data quality and more reliably deliver on the cost savings achievable through risk-based monitoring. AptivInSite™ is an umbrella methodology underpinning the Company's approach to risk-based quality management for drug, device, and diagnostic trials. The new approach embeds advanced statistical sampling to more efficiently manage the on-site monitoring process.
Clinical on-site monitoring employing 100% source data verification (SDV) is one of the largest drivers of the costs of a clinical trial. Although alternative monitoring strategies that involve reduced SDV, including risk-based monitoring, have been proposed for several years, these strategies have not yet been widely adopted across industry. The primary reason for low adoption appears to be lack of clarity from regulatory authorities as to what constitutes sufficient and acceptable monitoring. Regulatory authorities have recently released specific guidance on the acceptability of alternative monitoring approaches.1, 2, 3 Applying this framework, Aptiv Solutions has developed AptivInSite™, a novel approach to trial quality management that complies with the available regulatory guidance.
Verification by Statistical Sampling (VSS) uses a proprietary statistical sampling algorithm4, developed by Professor Andy Grieve, Senior Vice President, Clinical Trial Methodology at Aptiv Solutions. VSS provides the statistical justification to reduce the number of data points to be verified at each visit, resulting in fewer required monitoring visits and more time per visit to devote to improving data quality at the site beyond clerical transcription errors. This includes, for example, ensuring clinicians at the trial site are properly trained and faithfully following the trial protocol.
"Traditional industry methods are not grounded in a defensible statistical approach. VSS allows monitoring, measurement, and management of data quality and site related risks in real time," says Grieve. "The result is a robust, effective risk-based monitoring approach that uses resources efficiently, reduces monitoring costs, and improves quality in a manner fully aligned with current regulatory guidance."
The deployment of the VSS methodology can reduce monitoring time significantly. For example in a trial deploying 25 sites (340 patients), the number of site visits can be reduced by 46%, resulting in cost savings of $450,000.
The 100% SDV approach distributes resources across all clinical trial sites equally, even though some sites require greater scrutiny. An advanced statistical sampling approach, such as the one employed in AptivInSite™, verifies data quality at each trial site and redirects resources to the sites with lowest data quality and hence, the highest risk for problems. Overall data quality is improved, allowing cost resources to be deployed more efficiently.
"Brute force does not always produce the best data quality. There is a smarter approach that allows more resources to be applied to the sites that need it most. Risk-based monitoring is no less vigilant in the oversight of the trial, but rather focuses on preventing and mitigating important and probable risks," says Grieve.
AptivInSite™ deploys a Trial Design Toolkit to conduct an initial assessment of all the potential risks associated with a trial, simulating monitoring schedules, and generating cost scenarios. Additionally, its Execution Toolkit works within the framework of AptivAdvantage™, the Company's integrated technology platform that incorporates EDC, randomization and inventory management, to generate the data sets for analysis, determine site errors, and uses individual site performance metrics to adjust on-site monitoring schedules in real time.
"The combination of our VSS tool with the advanced execution platform for real time analysis of individual site metrics delivers a unique approach that takes risk-based monitoring to a new level" said Dr. Mike McKelvey, Chief Operating Officer at Aptiv Solutions. "It allows us to define data and site quality in a measured, quantifiable way as opposed to relying on more qualitative notions of quality that many risk-based monitoring schemes use today."
The white paper titled 'A Novel Approach to Risk-Based Monitoring (Introducing Verification by Statistical Sampling and AptivInSite™)' is available at http://www.aptivsolutions.com/aptivinsite/.
1. European Medicines Agency. Quality Risk Management (ICH Q9). 31 January 2011.
2. MDC/DH/MHRA Joint Project. Risk-adapted Approaches to the Management of Clinical Trials of Investigational Medicinal Products. 10 October 2011.
3. FDA. Guidance for Industry: Oversight of Clinical Investigations - A Risk-Based Approach to Monitoring. August 2013.
4. Grieve AP. Source Data Verification by Statistical Sampling: Issues in Implementation. Drug Information Journal. 2012; 46(3):368-377).
About Aptiv Solutions
Aptiv Solutions is a global development services company focused on enhancing clinical trial decision-making, efficiency and productivity for pharmaceutical, biotech and medical device sponsors. It is the only CRO to offer design, simulation and execution of adaptive clinical trials along with an extensive portfolio of innovative full service and functional outsourcing capabilities. These services span the entire product development cycle from first in human through regulatory approval to post-marketing. Aptiv Solutions has more than 850 professionals in North America, Eastern and Western Europe, Israel and Japan. Learn more at www.aptivsolutions.com.