StudyOptimizer gets patient enrollment programs back on track

December 11, 2009 – 4:27 pm by Colette Pilkus

Bringing a drug to market in a timely fashion is difficult and one of the biggest challenges facing pharmaceutical companies. Due to patent expirations, shrinking drug pipelines, and the financial crisis on Wall Street, manufacturers are being forced to speed up the drug-delivery process to bring drugs to market and capitalize on the revenue. Companies are looking at clinical trial patient enrollment as one of the most promising areas for operational performance improvement. By improving performance, companies can not only reduce costs, but increase the likelihood of clinical trial success.

Streamlining regulatory review processes such as clinical development are key in making companies successful, according to Alan Louie, Ph.D. research director at IDC. Any way companies can streamline clinical trials and advance in those areas means reduced time to new revenue and more sustainable companies in the long term, Dr. Louie says.

Clinical trials are becoming larger and more complex. Studies show that 95% of clinical trials fail to complete on time with the biggest issue being enrollment. DecisionView is a Web-based software solutions company that enables life science organizations to improve clinical trial performance. The company may offer an answer to this growing problem.

“Accurate prediction of patient enrollment represents a very significant opportunity for pharmaceutical companies to optimize their clinical trials,� says Jim Scullion, CEO, DecisionView. “One problem is that pharmaceutical companies need to capture, analyze, and leverage this historical clinical trial enrollment data to drive their plans and future patient recruitment efforts. This is a critical baseline that life sciences organizations need to benchmark and improve these processes.�

According to Mr. Scullion, pharmaceutical companies are now coming to DecisionView for ways to improve their internal and external processes so they can deliver a drug to market faster, have a better ROI, and save time and money.

DecisionView’s StudyOptimizer allows clinical trial managers to plan, track, diagnose, and correct enrollment plans through a single centralized Web-based application that captures and aggregates clinical trial patient enrollment data from across the organization. The application uses predictive analytics to forecast enrollment trends and estimate completion dates, which are updated based on actual enrollment patterns and give clinical trial managers the necessary information to measure actual and projected performance against plan. Because StudyOptimizer’s clinical trial software enables faster, more predictable clinical enrollment, trials can finish on budget and on schedule.

“It is used by our customers to drive consistent and best practices, business practices across the organization by leveraging the automation of our application,� Mr. Scullion tells R&D Directions. “It’s an extremely powerful application in that it identifies problems before they impact patient enrollment schedules, and it allows organizations and clinical trial managers to make corrective actions early in the process in order to get their patient enrollment program back on track. This is significant because it saves our customers hundreds of thousands or millions of dollars per trial. It’s a very cost-effective program.�

DecisionView recently launched StudyOptimizer 4, the most recent version of the product, which now includes advanced historical analysis and templates capabilities, as well as enhancements to its predictive analytics technology. The improvements give clinical trial managers a 360-degree view of their organization’s clinical trial patient recruitment performance with past enrollment patterns and metrics, present enrollment actual performance compared to plans, and future forecasted end dates of trials based on performance to date.

“What we offer and what [companies] need is the ability to capture, analyze, and leverage historical clinical trial enrollment data in their planning process for patient recruitment and scenario modeling,� Mr. Scullion says. “Actual data is being brought forward and companies are comparing their actual performance against their planned performance.�

According to Dr. Louie, StudyOptimizer 4 provides the ability to gain a better grip on managing the entire recruitment process, which becomes direct cost savings on the front end.

The market for products like DecisionView is heating up. Mr. Scullion expects competition from other software companies by the end of 2010.

“Compared to some of the solutions out there, DecisionView is clearly in front at this point,� Dr. Louie says. “The clinical development process is a fairly sizable effort that has a lot of electronic solution components that are being connected together. There are very large major vendors that are starting to build comprehensive solutions to capture all the different facets and different pieces that are needed to automate the process or make it more transparent in terms of the information being shared. They’re looking at it as well in terms of figuring out ways that they can help companies address different processes in clinical development.�

Tags: clinical trials, DecisionView, IDC, StudyOptimizer