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Pharma: A blueprint to manage clinical trial enrollment forecasting

July 18, 2007

Pharmaceutical companies spend enormous sums of money on research and development (R&D) every year. One analysis puts the worldwide total at $90 billion in 2005.¹

That's roughly $14 for every human being on the planet, and the costs are rising steadily.

The $90 billion figure represents an increase of more than 50 percent from 2001. Predictions are that companies will increase spending by at least seven percent per year through 2009.²

Estimates of the cost to bring just a single drug to market range from $800 million to $1.7 billion.³ Where does that money go?

Clinical trials the biggest part of R&D spending

Laboratories and high-tech medical equipment consume a sizeable portion of the R&D budget. But the largest single fraction of spending goes for clinical trials.

A 2007 report on R&D cost drivers prepared by Accenture for the Pharmaceutical Research and Manufacturers of America (PhRMA) found that "36 percent of the R&D budget is going toward late stage development, mostly due to the rather expensive Phase II and Phase III clinical trial process..."³

Phase III clinical trials are those in which large numbers of patients are enrolled in multiple locations around the world.

Point applications provide partial solutions

To manage their Phase III trials, many companies use Clinical Trial Management Systems (CTMS) to record and store patients' medical data, while spreadsheets are used for modeling and forecasting.

CTMS are adequate for portions of their respective tasks, but they have serious shortcomings when applied to a large-scale process.

CTMS lack the forecasting capability to effectively model the full enrollment picture across a worldwide development portfolio.

Spreadsheets introduce problems of version control. They also lack important enterprise capabilities such as managed workflow and the ability to provide templates to hundreds of users simultaneously.

The result? Information is kept in silos and a great deal of manual effort is required to keep the process on track. There is, however, a better solution.

A Blueprint for managing patient enrollment

As we discussed in the last issue of Performance Perspectives from Cognos, an IBM Company, IBM Cognos Performance Blueprints offer a way to manage both the financial and operational aspects of large-scale clinical trials.

The Blueprints are pre-configured planning, reporting, and policy templates based on IBM Cognos 8 Planning and IBM Cognos 8 Business Intelligence.

The Clinical Trials Forecasting Blueprint (see Getting past "Eureka!" in pharma, Performance Perspectives from Cognos, an IBM Company, June 5, 2007) allows you to track and forecast the overall costs of a specific trial or even a whole portfolio of clinical trials.

The Clinical Trial Enrollment Forecasting Blueprint zeroes in on the enrollment details to assure that a specific clinical trial has sufficient numbers of patients to meet its goals.

Blueprints working together

The two Blueprints are designed to work together, enabling changes in enrollment projections to update financial projections seamlessly.

Color-coded reports enable quick identification of sites with excessive enrollment windows, and allow easy drill-down into underlying detail. Enlarge.

By linking enrollment and financial data, managers can better understand the cost of changes and the dollar effect of evolving enrollment projections.

The Clinical Trial Enrollment Forecasting Blueprint provides dashboards, analytical reports and a pre-configured data model that consolidates data from the individual site level up through regions and countries.

The Blueprint alerts managers to trends and patterns, and allows them to drill down to perform detailed analysis and pull information from multiple transactional and planning systems.

Managers can easily examine the enrollment status of a specific test site or across a range of sites.

The Blueprint's forecasting assumptions cover all possible scenarios and eliminate the need for manual, off-line number crunching.

The model is also updated automatically to reflect input from users throughout the system so that changes to one of the assumptions will recalculate all the affected data instantly.

Open business rules and a flexible model

With open business rules, the model is flexible enough to be changed or modified by business users as needed, without costly development and complex coding.

The result is that managers can make timely decisions on whether or when to shut down test sites or set up additional sites as the clinical trial progresses.

Managing the enrollment process effectively is essential to help pharmaceutical companies control their growing costs.

But the even greater value – both for the companies and the customers they serve – is assuring that the clinical trial process accomplishes its goal of proving the safety and efficacy of the drugs that are under study.

Summary

The Clinical Trial Enrollment Forecasting Blueprint enables pharmaceutical companies to track enrollment indicators that can affect the progress of a costly study.

The Blueprint helps overcome the problems of data integrity and information silos characteristic of spreadsheets and Clinical Trial Management Systems (CTMS).

Using the Blueprint, managers can identify problems, and direct resources effectively to ensure that patient enrollment is adequate to produce a successful clinical trial.

Find Out More See the Blueprint demo Download the Business Value Guide Visit the Cognos Innovation Center for Performance Management

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Sources

¹ EvaluatePharma® evaluatepharma.com, August 2006

² Goldman Sachs, PAREXEL's Pharmaceutical R&D Statistical Sourcebook 2006/2007, p.8

³ Pursuit of High Performance through Research and Development — Understanding Pharmaceutical Research and Development Cost Drivers, Accenture Health and Life Sciences Group, 2007

⁴ Ibid.