A Tale Of Two CROs
November 27, 2007
One highlight is a presentation by Pfizer’s Mike Collins. A VP of development operations, he was the subject of this February story on our site. Collins’ talk in October was more provocative and substantive. Not because he announced some new program. Just because Collins made a convincing (but unstated) case that Pfizer’s sheer size might actually be an advantage—not a liability.
It’s as if Pfizer must address key industry-wide problems in clinical development, because of its size, and do so effectively. A smaller company (and some not-so-small ones) could let this sand remain in the gears. Some people like sand in the gears, after all. But Pfizer, facing generic versions of Lipitor, needs bigger efficiency gains.
As our earlier story noted, Pfizer used a data repository (not a trial in the real world) to win a new label indication for Viagra. (The company had already completed 230 studies of the erectile dysfunction drug.) Collins reviewed a bit of that territory in his October talk. “By managing your data smartly, you can move your products forward,” he said. Amen.
The Viagra repository turns out to be equally helpful when safety questions (from regulators) or negative publicity (from any direction) arise, Collins said. “Whenever we get a query from a regulator, or a press release, we can screen that database and within hours have an answer about how many patients have had that adverse event versus its comparator.” Can your team do that?
Questions Of Scale
Collins also reviewed Pfizer’s ongoing effort to find efficiencies in every corner of its clinical trial process, which the company was able to segment into 5,000 elements—and trim to 1,500 at the end of its re-engineering exercise. That may sound high, but the scale of clinical trials at Pfizer is predictably mind-boggling. The company has 13,000 active clinical sites, 670 ongoing trials, 150,000 patients. “It’s a huge business we work in,” Collins said.
What is the key to streamlining its clinical trial process? Standardization. “I am talking about innovation by standardization,” Collins said. “We were running uphill against standardization. That’s been a real change for us in the last 18 months.”
By standardization, we hasten to note, Collins seems to mean simplification or something close to finding one smart way to do something that works across a global company. Collins explicitly said he likes CDISC data standards, but his presentation concerned a far broader effort to get everyone at the company on the same page.
On this occasion, compared to earlier in 2007, Collins’ remarks had a more urgent tone. There was a degree of impatience. This was puzzling: we doubt many companies can point to such a thorough rethinking of their own clinical trials. But Collins seemed frustrated that there is no way for the company to look broadly across its finished trials by therapeutic area or data element. Said Collins: “The sad thing is we haven’t got a database that looks across all the placebo data or all diabetics. That, for a knowledge-based company, is shameful.” He also made a joke about Pfizer owning different but incompatible document management solutions from the same provider.
Still, the company does have other things to be proud of. It has slashed numbers of standard operating procedures (SOP) from 1,200 to 100. It has one global template for all clinical trials.
Which is not to say he’s done. Collins posed rhetorical questions about how long it should take to generate a final study report and mused about other bench marks and metrics. “A case report form that should be 30 pages is 45 pages,” Collins lamented. “It’s got stuff in there we don’t really need.”
Knowing The Obstacles
The company has a private website, which he termed a blog, to collect ideas about process improvements. It’s for the subject matter experts, Collins said. But Pfizer also hopes to collect ideas from a much broader segment of its staff.
One common objection to the streamlining, Collins said, often proved to be illusory. “Everyone would assert ‘the regulations wouldn’t let us do this.’ That was one of the little road blocks.” Fortunately, Pfizer’s regulatory experts could be quickly consulted to referee the merits of such claims, and they invariably concluded that a particular change carried zero regulatory risk. Naturally, the company has also been inspected by the feds, and Collins says they have had no problem with its road map.
1 Room, 2 CROs
Collins was a persuasive evangelist for efficiency, both at his company and across the industry. “You’ve got these huge cycle times which are based on all this white space that we have to drive out of the system,” he said. He said cycle time for database setup had been reduced by more than 70 percent, from two or three months to twelve days. There is a similar reduction in people involved: one specialized person (and not a Pfizer employee) handles the work.
In another key example, Collins named two contract research organizations that do a fair amount of work for Pfizer—INC Research and Icon. Together, Collins said, the two firms handle much of the negotiations with sites and investigators working for Pfizer. The big pharma put its rival CROs in the same conference room and asked them to agree on additional ways to streamline their processes. “Which was a bit uncomfortable at first,” Collins noted. “We said, ‘guys, we want you to work together.’ But partnering with our functional service providers is a key way forward for us. The big challenge we all have is about execution and implementation.”
Collins reports the CROs were cool to each other at first, but then dove into the task and got it done. Their productivity, according to Collins, has doubled. The two firms now meet on their own to continue the collaboration.
Naturally, different heads of therapeutic areas will lobby and argue for some idiosyncratic way of doing things. But at Pfizer, Collins reports, even the oncology team has begun to see the light, grasping enterprise-wide benefits to simpler case report forms or fewer data elements per trial. “We thought we’d never get oncology do to this. But they are our leading stars,” Collins noted. What used to be 12 different ways to size tumors have now been reduced to a more manageable but unstated number, he said.
If Pfizer has indeed managed to extract efficiencies for the company as a whole at the same time it has earned the cooperation of a key therapeutic area, it’s a significant step. In time, the company might actually be able to leverage the breadth of its expertise spanning multiple decades and therapeutic areas. The proof will be in the pipeline, and visible to outsiders only in the next few years. But it’s encouraging that a large sponsor is making such a serious effort to be nimble, too.d9A2t49mkex