Info & Opinion
April 24, 2019
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David Underwood of Quanticate says some firms are giving short shrift to the basics of clinical trials
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Late last month, in sun-blasted Phoenix, the 2011 Partnerships In Clinical Trials conference featured Denise Calaprice-Whitty of The Avoca Group. We had interviewed Calaprice-Whitty last year, for this article, and had privately hoped to coast through her presentation. But that proved impossible, as she had new data. We paid close attention.
Her employer is specializing in mapping the twists and turns of the outsourcing age—both the disappointments for those who are moving work outside their companies, and the frustrations of those taking on such labors.
The news in Phoenix was neither bleak nor rosy. The Avoca Group's surveys and consulting engagements suggest that happiness is unevenly distributed throughout the contract research landscape. Some sponsors are extremely pleased and believe outsourcing is working well. At other firms, less enthralled with outsourcing, quality is a concern. “Quality is on the dragging down end of what is contributing to sponsor dissatisfaction with their providers,” Calaprice-Whitty said.
She continued: “What we didn’t see so much dissatisfaction with was Quality 101—choosing the standard operating procedures (SOP), following the SOP. Those kinds of things the sponsors felt were done well. But for a lot of other things, the dissatisfaction rates were really quite high.” One takeaway message is that creating happy sponsors of a clinical trial requires more than just garden variety platitudes about customer service in general or clinical research in particular.
Indeed, the Avoca Group recently surveyed more than 240 clinical trial professionals, with more than 100 sponsors among those who provided answers. “Fifty-two percent felt the quality was not as good as they would have received if they had been using their in-house staff,” Calaprice-Whitty noted of sponsors. That's not a huge endorsement of outsourcing.
One of the interesting angles of Calaprice-Whitty’s presentation concerned micromanagement. It’s a touchy issue. What contract research organization (CRO) would confess that it needed to be micromanaged? But it definitely happens, according to Calaprice-Whitty, and her group tried to understand the dynamics of continuing to fuss over work you are paying someone else to handle.
Can I Help You With That?
Sponsors elect to micromanage, she suggested, when they have less confidence in a CRO, or observe that the CRO is not proactive about identifying (and solving) problems. On the other hand, for sponsors that have calibrated their expectations of CRO performance correctly, micromanagement isn’t practiced or necessary, Calaprice-Whitty contends.
One hopeful development in sponsor-CRO alliances is the usage of written agreements to delineate a certain quality of service. “Ninety-four percent of those that use written clinical quality agreements are satisfied,” she said.
When the survey results were further analyzed, the analysis showed that almost three quarters of companies are using such agreements. But only half of those companies are using the pacts proactively, to identify problems while a trial is under way. CROs that are proactive with sponsors seem to make sponsors happy.
There is a similar story with metrics, and a similar predictive value for their proactive use. It’s not enough, it appears, to use metrics from a third party or invent them as you go along. Rather, Calaprice-Whitty notes, what seems to distinguish the most contented CRO-sponsor relationships is the proactive use of metrics to adjust a trial's path while it is in progress. She added: “Those people ended up with very high satisfaction levels. We found these results over and over.”
The issue of being proactive and anticipatory was also a theme of another presentation at the Partnerships meeting. And if there is a single job description responsible for a disproportionate share of misery in CRO-sponsor discussions, it is probably that of the purchasing manager.
Depending on where you sit, then, a gentleman like Anthony Carita, director of global clinical outsourcing at Otsuka Pharmaceuticals, could either be your new personal hero or something out of a bad dream. He's a purchasing guy in clinical trials. In addition to working on the sponsor side of the equation, Carita has worked at CROs and spent years in the aerospace industry. Carita was a bit gruff and irreverent but in an engaging way.
He clearly has a lighthearted view of the jargon around outsourcing. Do phrases like preferred provider or strategic partner represent anything genuinely new? Not for him. “We've just taken our concept from 10 years ago and given it a new name,” says Carita. “It's not anything different than what we've done before.”
If a new idea in an outsourcing relationship isn’t given sufficient time, he implied, it’s impossible to tell if it was a good one. “How do you know if something has time to work?” he asked. “You don't if you don't give it time.” If an idea can only be assessed by looking at it for the duration of a Phase III trial, that's how long it should be evaluated.
There is no need, Carita says, to overstuff a bid. “I’m a huge believer in page limits on proposals,” he says. “We have page limitations for each section.” As a formal contract is being developed, he adds, it is important to be equitable. Says Carita: “You don't want all the risk to be with the sponsor, you don't want all the risk to be with the provider. You want to try to balance the risk.”
Tough on PM
It’s clear that even the most sophisticated CRO would not attempt any fancy contractual footwork with Carita looking over the legalities and invoices. For starters, now that he is working at a sponsor, he objects to some fees charged for project management.
“I'm not going to pay for project management on the basis that somebody exists,” Carita said. “There needs to be some performance linked to project management. Quite honestly, if a CRO doesn't have any sites up and running, what are they doing in the first three, four, five, six months?” He prefers that project management be linked to specific milestones and deliverable elements.
Like everyone else in the sponsor community, it appears, Carita has encountered situations in which eminent folks who appeared at a CRO bid defense did not actually work on the trial. Perhaps the distinguished individual's curriculum vitae was so gold-plated that it was loaned out on another bid defense or a live project. Whatever the case, such disappearing acts rankle Carita. So just getting an organizational chart from a CRO is not sufficient. “Provide me with named resources,” he suggests.
Carita devoted a lengthy section of his remarks to change orders. It's clear he sees them as a major issue for the industry. Beyond that, he’s not opposed to change orders as a matter of dogma, and can understand circumstances in which they are warranted.
But in a perfect world, change orders would be used more sparingly, and tied tightly to each organization’s responsibility for an underlying problem. As an example, suppose a sponsor selected the investigator sites in the trial. Suppose also that the recruitment of patients is behind schedule. That set of circumstances, clearly, is not the CRO’s fault. A change order would be warranted.
In other instances, in Carita's view, the responsibility and the cost might hit the CRO. And the approval and communication details around the change order do matter. Says Carita: “[Change orders] should be in writing to the person who is in charge and has authority to accept the changes. We should never hear about a change in scope after the work is done. It does happen, unfortunately.”
He did share a bit of information relating exactly how Otsuka handles some of its CRO contracts. As the rest of his presentation suggested, there is a great deal of specificity around every deliverable.
If the CRO and Otsuka agree that a trial will require, say, 100 units of monitoring work, the CRO is only paid for that many. The CRO cannot present a bill for 110 or 150 units even if that is what the trial required. “We use fixed unit price contracts,” Carita explained. The good news? If the CRO is more efficient than anticipated, it can keep the difference.
Taken together, the two Partnerships presentations suggest a contradiction in clinical project management. A few organizations that are excelling at proactive project management are delivering off-the-charts satisfaction to an extremely discerning customer base. But the willingness to pony up for some of that project management expertise, both over individual careers and on a single study basis, appears to be in doubt in an era of tighter financial and operational scrutiny.