Health Decisions’ Agile Clinical Development is the most comprehensive methodology in the industry, uniquely combining everything necessary for successful programs and projects:
- Immediacy of information flow (LiveData)
- Streaming performance metrics focus on key study elements to reduce timelines and rework
- Actionable information enables continuous assessments
- Continuous decision-making
- Operational: enrollment strategies, risk-based monitoring, improving site immediacy and quality
- Design: adaptive designs enable mid-study adjustments to key design parameters
- Insight and experience map the shortest path to market
Agile operations and adaptive design both have the potential to provide substantial increases in the efficiency of clinical studies. Agile operations are comprehensive, involving continuous refinement and optimization of all aspects of study operations. Adaptive designs are highly selective, enabling specific predetermined changes in design parameters in accordance with approved decision rules that may be carried out by an independent group such as a Data Safety and Monitoring Board. Agile operations increase efficiency in all studies, often substantially. When adaptive design is appropriate and consistent with sponsor preferences, there are further improvements in efficiency from adaptive design techniques and from synergy between Agile operations and adaptive design. LiveTrial technology enables Agile operations and adaptive design to work in synch, maximizing efficiency.
Agile Clinical Development in Action
Example 1: If the treatment effect exceeds planning estimates, adaptive sample-size reestimation would enable a decision to reduce sample size. Agile operations implemented through LiveTrial technology would provide the information necessary for the decision to reduce sample size. Immediately after the decision, agile operations would ensure timely implementation of the reduced sample size, preventing enrollment of excess subjects.
Example 2: With an adaptive dose-finding design such as the Continual Reassessment Method (CRM), Agile operations enabled by LiveTrial technology provide response data rapidly, reducing cycles for dosing decisions and thus allowing earlier identification of the Maximum Tolerable Dose or Dose Limiting Toxicity.
Components of Agile Operations and Adaptive Design
Agile operations include:
- Agile enrollment
- Agile Risk-Based Monitoring+
- Agile resource allocation
- Agile reporting
- Agile business intelligence
Adaptive designs include:
- Sample-size reestimation
- Seamless phase transitions
- Adaptive dose finding (e.g. CRM)
- Adaptive dose pruning
- Over 15 other adaptive design methodologies
Agile Risk-Based Monitoring+
Health Decisions Agile RBM+ optimizes monitoring based on LiveData, comprehensive performance metrics and a multivariable model that identifies and adjusts the best predictors of data quality based on actual conditions observed during each trial. Agile RBM+ is consistent with regulatory guidance on risk-based monitoring but also goes far beyond, delivering exceptional value as well as ensuring data quality and patient safety. The multidisciplinary Agile RBM+ monitoring team assigned to each study includes not only the PM and CRAs but also a biostatistician and QA professional. Agile RBM+ enables Health Decisions to provide sponsors with simultaneous increases in data quality and reductions in SDV. Central statistical checks identify any issues in unmonitored data. CIO Magazine named Health Decisions to its prestigious 2013 CIO 100 because this monitoring approach provides true business value. View more information on Agile Risk-Based Monitoring+.
Agile enrollment utilizes comprehensive metrics based on LiveData to optimize recruitment based on source, marketing method, message, reasons for screen failures and other key factors. The PM allocates resources dynamically, supporting the recruitment strategies and tactics that prove most effective in practice. Agile enrollment has enabled Health Decisions to enroll more than 80% of its studies on time, usually by optimizing performance of the initial sites. In especially difficult studies, agile enrollment may utilize rapid activation of a second tier of prequalified sites if first-tier sites are disappointing. View the white paper, 10 Steps for Faster Enrollment: Optimizing Patient Enrollment in Clinical Studies.
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