Software Tools Help Manage Clinical TrialsSoftware Tools Help Manage Clinical Trials

In the pharmaceutical and life sciences industries, it's estimated that 70% of clinical trials are delayed due to patient enrollment problems. Those delays can tag on millions of dollars of added research and development and other costs to trials, not to mention cause postponements to promising new treatments entering the market.

Some pharmaceutical companies, including GlaxoSmithKline, are starting to get a better handle on patient enrollment issues earlier on in trials, helping them take action sooner to keep clinical trials on track.

At GSK, the average clinical trial involves about 400 patients at 60 sites in five to eight countries, said says Alex Lancksweert, GSK director of business performance analysis. However, some larger clinical trials can include thousands of patients and involve hundreds of clinical investigators globally. But frequently, trial sites -- which could include hospitals, clinics, and other healthcare facilities -- run into difficulties recruiting a target number of patients meeting trial requirements.

Those enrollment problems can involve lackluster patient recruitment efforts, patients dropping out of trials prematurely because of other medical issues, including pregnancies, regulatory changes unfolding in a country, and other challenges.

Through the use of DecisionView's StudyOptimizer over the last year or so, GSK has doubled its efficiency in patient recruitment for clinical studies, Lancksweert said. The Web-based software allows GSK clinical investigators see how their trial sites in various countries are tracking in terms of recruiting and screening patients based on study targets and compare their progress with other trial sites.

DecisionView CEO Jim Scullion said the power behind his company's newest release, StudyOptimizer 4, is in its ability to make "real time" forecasts about the progress of current trials based on analysis of historical data from multiple sources about a company's previous trials, including performance of specific clinical sites and countries. Predictive analysis helps clinical trial managers forecast accurate study end dates based on performance of the trials so far and historical data analysis. The transparency provided by StudyOptimizer via the Web allows clinical investors and study managers keep abreast of trial sites and countries that are experiencing patient enrollment issues---such as not recruiting enough eligible patients or patients dropping out of studies prematurely. These insights enable clinical managers to address the issues, such as ramping up recruitment efforts at a weaker performing site, or perhaps instead increasing efforts at sites in other countries that are having more success in recruitment.

"If Argentina is not performing because of requirement issues or other reasons, then maybe we can get more patients in China, which is up and running well," said Lancksweert about the ability of study investigators and managers using Optimizer to see how recruitment is going in their region, as well as the ability to use the software to model scenarios for reaching targets -- and testing whether deadlines are "realistic," he said.

Data analysis using StudyOptimizer can be used to improve planning for shipment of drug supplies to the most active trial sites, so that there are no delays in willing and eligible patients receiving the test medications, said Scullion.

The "transparency and engagement" that the software tools offer also fuels competitiveness among clinical investigators to get the job done of recruiting eligible patient, he said. "There's been a significant improvement in unproductive sites," he said. In general, in the pharmaceutical industry, it's estimated about 1/3 of sites responsible for enrolling patients fail to recruit any patients. "A lot of effort is wasted," he said. By providing clinical trial investigators with these Web-based management tools, the spirit of competitiveness is boosted among sites. "Whatever the reason, people are trying harder," he said.

While Lancksweert declined to estimate how much GSK has saved in its clinical trial costs since using StudyOptimizer, he said that in general, clinical trials by pharmaceutical companies cost from $5,000 to $35,000 a day. When reaching patient recruitment goals for clinical trials, "every day is money saved," he said.

DecisionView StudyOptimizer is available via software-as-a-service or on-premise model.