Wyeth has been talking about the redesign of its approach and philosophy to clinical trials for years.

As many readers know, the company restructured its drug discovery effort, and then tackled clinical—with some help from Accenture, which took over key tasks like data management in an open-books partnership. In that arrangement, both sides are sharing costs and responsibilities as well as risks and rewards.

That’s the history. At the Clinical Trials Congress this year, Wyeth discussed where it wants to go. For many senior managers in the audience, Wyeth’s discussion could have been simulataneously exciting and discouraging. Exciting because Wyeth seems to believe a transformation of clinical systems is an immediate, feasible thing. And discouraging because all of the technology adoption and process change that have already taken place may be just the beginning of a very long journey.

Ira Spector, Wyeth’s VP of clinical development and vice chief of operations, gave a panoramic address. He tried to lay out where his company wants to go, and where it thinks many other companies in the industry will also be obliged to venture.

Industry’s Image

Spector reviewed the familiar figure of $800 million in costs to find a new blockbuster. He cited it as one of many pressures bearing down on the industry. At the same time, the industry’s slippage in opinion polls has him puzzled and concerned. “We’re below car manufacturers and the telephone companies. This is not good. We did not go to school for all those years to have the perception that is going on in this industry.”

Those dynamics are familiar. They are the backdrop for what Wyeth, Lilly, Novartis and other companies hope will be a shift toward a simplified, streamlined drug approval process.

Such a process would be more dependent on technologies that many in the industry are struggling to adopt. The new approach is a two-stage paradigm. In the first, sponsors would learn about a new product in small numbers of patients. In the second, sponsors would confirm their initial findings in larger cohorts of patients. Some people call this “learn and confirm.”

Efficiency Drive

“We really have to get more efficient,” said Spector. “We have to be conscious of time and costs. Adaptive design is the key to this. We want to conduct trials that help us find the right dose early. Also we want to have the right number of patients.”

He readily conceded that an adaptive, learn-and-confirm approach is nothing that will happen immediately, either in Washington or industry. But Wyeth appears to be preparing for an eventual transition to a world in which technology could enable much swifter decisions that would be understood (and blessed) by regulators on a much faster schedule than is now the case.

Super Shipper

In some cases, the pressure for efficiencies has nothing to do with grand alliances like the one with Accenture, but with attention to mundane details. Like customs and logistics.

Spector noted that Wyeth has a global agreement with DHL, the shipping company, to handle the timely delivery of drug supplies worldwide. DHL, unburdened by the pharmaceutical industry’s unhealthy adoration of paper, offers Wyeth continuous visibility into the status and location of all shipments. Said Spector: “We want visibility, at any time, of all the materials for a trial. They have the technology. Why should we have people phoning sites, faxing sites? The goal is to have complete visibility on everything, inbound and outbound.”

But longer term, much more profound changes for adaptive approaches will affect the planning and execution of trials. Such changes will have to be explained and more or less evangelized throughout large companies. Said Spector: “How do you plan sites? How do you plan drug supplies? It is changing the way you work. The key is having access to data early.”

2M CRFs

Much of that data is still starting on paper, of course.

Wyeth is now processing about 2 million pages of data a year, Spector said. Of the new studies that the company launches, roughly 90 percent use electronic data capture (EDC). “We’ve crossed over between paper and electronic last year.”

He believes the industry and his company are currently using unidentified first- and second-generation EDC platforms. “We’re trying to make the transition be first and second generation. That is what is going on now.” He did not name the companies Wyeth is working with. 

By his reckoning, first generation EDC systems just grabbed the data. Second generation EDC helped track sites. “Most of the EDC was first generation, how to get data in,” says Spector. “We’re not so excited about that. That’s the easy part. It’s how do we make good decisions.”

Third Generation EDC

With regard to EDC, Spector said a third generation of the technology will facilitate adaptive projects and support faster decisions about clinical programs. Those EDC systems will be fully integrated with a variety other clinical systems, and not stand on their own. “There is a 3rd generation out there,” Spector said, “once you have the pipe to bring the data in.”

Beyond technology, of course, people and teams and functional areas will have to reinvent themselves. Said Spector: “This is a very ambiguous way of working. People need to be comfortable. Implementing a new model of this type in a large organization takes leadership. It takes courage.”

Integration, Integration

The context of his remarks suggested that he believes there are other companies out there with fresh and more easily interconnected EDC systems. Such systems, he implied, will seamlessly integrate with (to name a few), clinical data management, interactive voice response, drug supply and statistical tools. Spector acknowledged that many companies in the industry share a fair degree of uncertainty about how to proceed with such trials.

One thing, however, is clear. “You cannot run adaptive trials without very close involvement with the regulators,” he said. Like industry, the agencies are also getting up to speed on adaptive approaches. “They are learning from what everybody else is doing,” Spector noted. “Eventually this will get more codified.”