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Getting past "Eureka!" in pharma (Or, a blueprint to manage clinical trials forecasting)

June 5, 2007

"Scientific innovation in discovery is not sufficient...companies need to be innovative in every activity involved in getting a commercially valuable product to market."
– Accenture

Where does innovation occur in the pharmaceutical industry? Is it only in the "eureka!" moments in the laboratory when a new drug is discovered? Those are essential, of course. But for a successful pharmaceutical company, innovation needs to go far beyond the lab.

Consulting giant Accenture examined the role of innovation in the business performance of top pharmaceutical companies in a research paper issued jointly with UK-based research firm CMR International.

Innovation "throughout the value chain"

The authors observed that "Scientific innovation in discovery is not sufficient and companies need to examine the possibilities to be innovative in every activity involved in getting a commercially valuable product to market."¹

Recognizing that only a small percentage of drugs make it successfully from the lab to full-scale commercial release, Accenture and CMR concluded that, in order for a company to be successful, "Innovation needs to be applied to how processes are designed and refined, how technology is used to enable the business, and how the organization is structured and people and teams are managed."

They urged pharmaceutical companies to innovate "throughout the value chain." And they asserted that "successful companies will be those that embrace innovation at every stage of R&D and marketing."²

Clinical trials expensive, daunting

Bringing a new drug to market is enormously expensive. The most expensive part of the process, however, is not the breakthrough in the laboratory, but getting the drug from the lab to the pharmacists' shelves. And the most costly part of that lab-to-market process is clinical trials.

Managing the resource requirements and accurately forecasting the costs of a large-scale clinical trial can be a daunting task. Programs are often run globally (China, India, and Russia being the leading overseas venues for clinical trials by major drug companies³) and involve the manual collection and consolidation of data on patient visits.

A new blueprint to manage clinical trials forecasting

This is where Cognos, an IBM company, offers an invaluable innovation in the form of its Clinical Trials Forecasting Blueprint, a pre-configured planning, reporting, and policy template based on IBM Cognos 8 Planning and IBM Cognos 8 Business Intelligence.

The clinical trial process requires a collaborative environment. Enlarge

The Blueprint is designed to help financial professionals and clinical trial managers forecast, plan, and manage expenditures using an activity-based approach that maps expenses to clinical trial activities. Developed by the Cognos Innovation Center for Performance Management™, the Blueprint enables an entire portfolio of development projects to be modeled uniformly.

Create reliable forecasts

In large-scale clinical trials, the patient visit is the underlying driver for the majority of costs. The Blueprint creates a reliable forecast by modeling such critical patient-visit factors as per-patient costs, retention, drop rates between visits and the timing of visits relative to each patient enrolled in the study.

Pre-defined formulas update the forecast for the actual activity and re-forecast based on a range of assumptions, such as the average monthly spend, and both cumulative and projected variances from budget.

Driver-based algorithms

The Blueprint accurately predicts clinical trial operating expenses, using driver-based algorithms and pulls data from multiple systems, accommodating multi-year projects and portfolio management processes.

It can model what-if scenarios and assess the performance of different sites or regions across the trial portfolio.

In addition, the Blueprint builds a performance data repository as a base for future decisions such as site selection for prospective studies.

Summary

The Clinical Trials Forecasting Blueprint provides accurate, real-time information that allows management to know how the trials are going, where the problems are and where resources should be directed to make sure that deadlines and cost targets are met.

It maximizes insight into enrollment indicators that can affect the progress of a costly study and enables finance and R&D to cooperate on hitting key dates in the FDA filing process. Most important, the Blueprint helps pharmaceutical companies extend innovation beyond the laboratory and throughout the value chain.

Sources

¹ Rethinking Innovation in Pharmaceutical R&D, Accenture Health and Life Sciences Practice, CMR International, 2005.

² ibid.

³ Bruce Einhorn, The Rush to Test Drugs in China, Business Week, May 28, 2007