Published on 30 Nov 2012
"IBM was able to show us case studies using Cognos Planning to manage clinical trials, and it seemed an excellent approach. The maturity of the Cognos solution and its close fit with our requirements gave us confidence that IBM could be the right partner for the implementation of the new CTPS at that time." - Piet Theisohn, Director Resource Management & Business Support in Global Clinical Development, Bayer HealthCare
Business Analytics, Business Integration, Business Resiliency, Information Integration
The process flow for managing Interventional clinical trials in Phases II and beyond – which usually run for many months or years, and typically span a number of countries – is highly complex. Following an initial planning stage, medical staff write a protocol for each trial, and operations staff then work with investigator sites to find the right mix of eligible patients across the most appropriate countries.
To further accelerate planning, improve the accuracy of cost forecasting, reduce administrative effort and optimise the overall management and transparency of costs in global clinical trials, IBM worked with Bayer HealthCare Pharmaceuticals (Bayer) to integrate their clinical trial management activities with financial planning activities.
IBM® Global Business Services® supported Bayer in creating a global clinical trial planning solution, covering processes, training and technology based on IBM Cognos® Planning software.
Using Cognos blueprints and accelerators enabled rapid deployment; iterative prototyping supports increased business requirements; provides a single, trusted data source for studies; enables business and cost driver-based planning; reduces effort, time and risk of error in planning; supports better decision-making to help improve cost-efficiency of clinical trials.
The process flow for managing Interventional clinical trials in Phases II and beyond – which usually run for many months or years, and typically span a number of countries – is highly complex. Following an initial planning stage, medical staff write a protocol for each trial, and operations staff then work with investigator sites to find the right mix of eligible patients across the most appropriate countries. This feasibility analysis is an iterative process which aims to determine the best approach to each clinical study based on the expected cost, quality and time-to-complete satisfying the scientific and regulatory requirements. Throughout the lifetime of each trial, managers must monitor actual spend against predicted costs, and create accurate forecasts of future costs. An ability to run ‘what-if’ analysis is central to effective planning and subsequent management of the costs associated with clinical trial programmes.
At Bayer HealthCare Pharmaceuticals, the various financial aspects of clinical trials were supported by different tools and systems, which was time-consuming and could sometimes be error-prone.
Piet Theisohn, Director Resource Management & Business Support in Global Clinical Development at Bayer HealthCare, comments, “Clinical costing is driven by the planning and the progress of each trial, and this information is tracked in the Clinical Trial Management System (CTMS). The lack of integration between the CTMS and our financial planning and management/tracking spreadsheets, therefore, was a problem. We needed to integrate our Clinical Trial Management System with our financial planning activities, so that we could achieve greater cost transparency. This meant being able to track the actual spend and to perform accruals and forecasting in an integrated manner as each clinical trial progresses.”
IBM was invited by Bayer to demonstrate a packaged and configurable solution based on IBM Cognos Planning Software; and based on the built-in accelerators and templates, the proof-of-concept stage was completed in two weeks.
Piet Theisohn comments: “IBM was able to show us case studies using Cognos Planning to manage clinical trials, and it seemed an excellent approach. The maturity of the Cognos solution and its close fit with our requirements gave us confidence that IBM could be the right partner for the implementation of the new Clinical Trial Planning System (CTPS) at that time.”
Using an iterative prototyping approach in which new functionality was built up, released to business users, and then refined based on their feedback, IBM Global Business Services helped Bayer develop its new CTPS – an integrated clinical trial financial planning and forecasting tool.
The single, centralised global solution spans the entire trial lifecycle, from early top-line planning to ongoing estimates for live trials, and facilitates the established top-down and bottom-up planning processes between the central clinical team and the in-country teams. CTPS provides a single, reliable reference point for current planning data, together with reliable documentation of historical data, for example, previous forecast cycles. Costs are distributed across years and months based on visit schedule and enrolment planning, and users can override drivers and results of automatic calculations manually if the standard models are not feasible for a specific trial or situation. In addition to providing a single, transparent and accurate reference point for current planning including drivers, basic assumptions and resulting costs, CTPS enables the rapid generation of new scenarios, helping Bayer to model and compare different approaches to each clinical trial.
Blueprints for success
IBM Cognos Blueprints are pharmaceutical industry-specific template solutions, designed to accelerate solution development by providing an ‘out-of-the-box’ solution that can then be configured to specific requirements.
IBM Global Business Services used several pre-built Cognos Blueprints in the creation of CTPS, including Clinical Forecasting (activity-based costing model for patient visits), Clinical Enrolment (actual and planned enrolment data for scenario-based forecasting of patient enrolment), Clinical Resource Planning (assumption-based resource planning and budgeting) and Clinical Modelling and Tracking (hybrid blueprint designed for feasibility, ‘what-if’ analysis, detailed resource planning and tracking).
Fast and more consistent planning
Today, the Cognos-based CTPS supports Bayer’s study managers to develop recruitment models and to monitor and analyse trials to reflect ongoing learning from strategic feasibility analysis. They can also develop and refine cost models based on recruitment-driven cost and timeline-driven cost.
For the central team, the solution supports the early selection of potential countries and enables access to key country information. In the countries themselves, the Cognos solution supports recruitment and cost modelling.
CTPS improves the planning process, providing a consistent model for patient enrolment as well as for the derived external costs. It documents the underlying assumptions, providing improved cost transparency, and supports cost updates for trials based on shifts in timelines or changes to the number of subjects and sites.
The accurate management of clinical trial finances is essential for a large global business like Bayer. With the new Cognos solution, the company aims to reduce the effort involved in managing and monitoring these costs, and to use this information to improve the planning of future trials. In combination with an enhanced feasibility approach to trial design, using the Cognos solution is projected to optimise the average number of countries in each trial as well as the respective tracking and planning efforts.
By enabling managers to make direct comparisons with historical metrics, the new solution should help improve the accuracy of planning and forecasting. It also will help by reducing effort and the likelihood of human error to provide a more reliable set of figures for the distributed clinical trial finance process.
“With CTPS, we have achieved integration between clinical trial planning and financial planning, enabling the study managers to see the basis behind the actuals and estimates”, says Piet Theisohn. “It’s not easy to quantify the benefits, but we are confident that the system will reduce the workload for study managers and country monitors.”
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