Darwin at Work: Trial Technology

The challenges facing the pharmaceutical industry have never been greater: patent expiries, increased government regulation, industry consolidation, declining drug discovery success rates, the impact of generics, the escalating cost of conducting clinical trials, non-performing sites, patient recruitment, etc. In this environment, clinical trial sponsors and researchers are being asked to demonstrate better returns on investment while maximizing efficiencies across the clinical trial process.

Garry D. Johnson

While there is no "silver-bullet," technology, and technology-enabled solutions, play an increasingly important role in reducing cost-drivers while simultaneously improving decision making and results.

Let's look at two examples: electronic data capture (EDC) and interactive web response (IWR) technologies. There was a time when clinical trial data collection, reporting, query resolution, and randomization were largely paper-based; at best, "spreadsheet-based." Today, using EDC and IWR, these tasks can be fully automated resulting in greater speed for study set-up, elimination of "double-data entry," improved accuracy (fewer errors), online data clarification forms processing, and electronic case report forms that can be automatically tracked and stored, as well as faster data lock. In addition, better access to information vastly improves the decision-making process allowing action to be taken earlier on issues ranging from compliance to site enrollment. With proactive, full-service data management, the availability of "clean data" is significantly enhanced.

So, the question is, with the increased focus on return-on-investment, efficiency, and effectiveness, why is it that only 40 percent to 50 percent (depending on the source) of clinical trials employ these proven technology solutions? I've spoken with industry leaders about this, some really smart people, and heard things like: "Pharma is very conservative, so we're slow to adopt new technology." Maybe so, but it seems to me that there needs to be a greater sense of urgency around this, especially given the unrelenting pressure pharma faces today—pressure to bring drugs to market faster, while controlling costs. Some of these options have been around nearly 20 years—folks, that's a couple of "technology millennia." Yet, based on personal experience, pharma seems to spend more on sales force automation (customer relationship management) than it does managing this critical business component.

Survival of the fittest

So how does "Darwin" fit into this? It's pretty simple really. Darwin said, "in the struggle for survival, the fittest win out at the expense of their rivals because they succeed in adapting themselves best to their environment." To which I say: "It's time to adapt."

Technology certainly isn't the only answer to solve today's business challenges (in pharma or otherwise), but it is an important part of the solution. At the same time, providers of clinical technology solutions need to do a much better job of making these systems more intuitive and easier to use. Partnership, instead of today's arm's length supplier model, will help speed the adoption of the new technologies required to meet the challenges to come.

In conclusion, (and with apologies to Alice Kahn), I offer the following thought: "For a list of all the ways technology has failed to improve the quality of clinical trials, please press three."

Garry D. Johnson Senior Vice President & Chief Technology Officer, BioClinica, Inc.