In Search of the Holy Grail

Chasing ultimate clinical trial efficiency, one small step at a time
Jul 01, 2005

P & GP eClinical System Evolution
Most pharma companies, including procter & gamble pharmaceuticals (P&GP), rely on a familiar line-up of information technology solutions to shorten clinical trials timelines, manage data and contain costs. Clinical data management systems (CDMS), clinical trial management systems (CTMS), electronic data capture (EDC), drug supply management (DSM), and interactive voice-response systems (IVRS)—all of these have become commonplace. Widely touted logistical and commercial benefits helped drive the rapid adoption of such programs in clinical studies around the world. And while companies like P&GP have reaped enormous benefits after implementing these programs, they all see a greater, unrealized upside shortly after implementation. These IT solutions would be much more powerful if they worked well together. But almost invariably they do not. What would it take to integrate the data so that each system could share information with its neighbors?

Unfortunately, building bridges between such systems is not easy. Even though the different programs use common data points and trial metrics, few of them permit data to flow smoothly from one to the next. Instead of monitoring a network of programs that update one another automatically, sponsors and site managers must devote hours every day to keeping the different systems in sync. To avoid these costs, P&GP set out to eliminate double work and extra steps like duplicate data entry and the time spent finding and correcting the errors that inevitably result. It turned out to be a tricky process, one that proceeded stepwise, a little at a time, and served up a few surprises along the way.

In the Beginning By 2002, P&GP had successfully implemented several systems to manage clinical trials and capture data electronically. Looking for ways to share common data, trial metrics, and so on, the company called on its vendors for help implementing the vision. Management identified three systems for initial integration: interactive voice and Web response (IVR and IWR), EDC and, later, the CTMS. The suppliers for these systems also recognized the value of sharing data between their systems. P&GP used ClinPhone's IVR and IWR for randomization and management of trial supplies, and also relied on ClinPhone's IVR system for the collection of patient diaries. The EDC system is Phase Forward's InForm™. More recently, the company began using Perceptive Informatics IMPACT application to aid the overall management of clinical programs.

Data integration turned out to be a high-stakes game. Four out of five studies take longer than expected, and issues at study sites account for almost 60 percent of these delays. ClinPhone estimates that keeping a trial running costs around $40,000 a day, while the impact on lost sales revenue is even more pronounced. Every extra day that a drug remains in clinical studies costs the sponsor at least $600,000 in lost sales. For a potential blockbuster, the daily revenue lost could reach eight million dollars.

Some of these costs can be traced to sheer excess optimism. "Investigators overestimate the pool of available patients who meet inclusion criteria and who are willing to participate in clinical research," says Louis Lasagna of Tufts University, summing up part of the problem.

But unnecessary steps in a trial process, or pointless duplication of documentary data, also contribute to the rising costs of clinical studies. Data integration could reduce the toll these costs take on clinical budgets. The quest for a solution begins with the fact that many IT systems used in clinical studies have common data points. For example, patient demographics might reside in several systems. An investigative site coordinator may enter patient demographics using the IVR database and later enter the same information into an EDC system. When cleaning data prior to locking databases, any data-entry errors or discrepancies between the two systems must be resolved. Of course, this takes time and resources. Integrated solutions would eliminate redundant steps—such as re-entering data. Sponsors could cut costs and save time. Equally important, they would reduce the risk of data entry errors.