After doing 20 trials together, Quintiles and ediary supplier invivodata announced a closer partnership. For the large contract research organization, the relationship likely brings additional scientific firepower to a research niche newly legitimized by a final FDA guidance document in patient reported outcomes (PRO).

For the Pittsburgh ediary supplier, meanwhile, the relationship will bring more projects and visibility on the coat tails of the largest services firm in the industry. The relationship is nonexclusive, meaning that Quintiles will still use ediaries from other firms, should sponsors require that—and invivodata can work with other CROs. The most delicate question about the arrangement may be: can PRO projects become routine? There are certainly nuances with matching patient diaries in clinical trials to the future marketing claims for a new drug or medical device. But presumably Quintiles would not put its reputation on the line unless it thought that invivodata could match its standards.

Indeed, invivodata co-founder, president and CEO Doug Engfer notes that Quintiles conducted an exhaustive review of his operations. It took a year. "We're honored and humbled to have been selected after what was a very rigorous process," Engfer says. Beyond his own firm, he notes, the deal signifies the importance of what his patient-reported outcomes (PRO) devices can harvest. "PRO data are key. They have strategic importance to Quintiles' key clients," Engfer says. Here's a news release summarizing the deal.

Quashing Doubts

Engfer says invivodata's business is roaring ahead, thank you, spurred by that December, 2009 release of final FDA guidance on PRO. Forward-looking sponsor firms had already internalized the 2006 draft version of the document. But now the usual foot-draggers, doubters and nay-sayers have less reason to run trials using paper booklets that require months of CIA-worthy handwriting analysis.

Some consumers, accepting their medicine across the pharmacy window, might be surprised to learn that modern pharmaceutical companies still trust pen-based chicken scratches from hundreds of patients to construct scientific justification for new medicines. Other consumers would be surprised that the FDA even permits such chicken scratching in the second decade of the 21st century.

Engfer, for his part, notes that the Quintiles relationship has already brought his firm opportunities of which it was unaware. Those are trials that were never really put out to formal bidding or quasi-public notice on the industry grapevine, simply because a sponsor had already decided it wanted Quintiles to handle the work. Because of such deals, Engfer says, invivodata has doubled its internal growth estimate for 2010.

M2M

Down the road, Engfer says, deep operational links between Quintiles and invivodata, especially across multiple research programs, hold out the possibility of connecting various silos of data and expertise. Such silos are a permanent feature of the landscape of industry-sponsored research, and the natural result of discrete teams of people making decisions in a patchwork, piecemeal process. A more comprehensive and strategic usage of PRO, Engfer says, could start to connect those silos.

How? "There is a broader strategy that is taking root where CROs take on end-to-end responsibility for a program," says Engfer. "The phrase Quintiles uses, which is brilliant, is molecule to market (M2M). Here's our program, help us design it, and you go execute it." That's a stark departure from the functional service provider (FSP) model, proponents of which excel in one or two narrow activities, leaving the rest of the trial to some other organization or team of organizations.

Engfer knows that big firms like Quintiles need to support both the FSP and the full-service approaches. But he believes there is growing appreciation for a longer term view in which a CRO takes on all aspects of the clinical development from preclinical to postmarketing. His own firm is already noticing a bigger swath of Quintiles-related Phase II work, suggesting sponsors are not relegating PRO projects until late in the development process. Doing ePRO work earlier, he vows, will eliminate bad products, and leave more resources for more viable research programs.

Says Engfer: "We can run fewer and smaller Phase III studies, and still reach statistical significance, and still prove the drug works—and ensure the study endpoints that have been selected are the ones that are appropriate. That not only integrates our operations with Quintiles', and our consultancy with Quintiles' consultancy, it helps integrate the clients' marketing direction with their clinical work."

Final Guidance

At the FDA, Engfer says, the dogma about PRO is spreading beyond a few divisions which had long grasped it. That augurs well for broader ediary acceptance across the rest of the agency, he says, as review divisions like dermatology and others start to refer the sponsor community toward the FDA's final PRO guidance. Says Engfer: "Even within the agency, there have been and are review divisions that have not enforced the draft guidance in the way others have. Within FDA, increasingly, the guidance that the review divisions give to pharma is going to be clear and unambiguous. Laurie Burke is working diligently within the FDA to proselytize the guidance and make sure it is absorbed in a consistent way."

The guidance, he says, did not contain substantive changes from its draft version. The agency simply tried to help the industry understand how to do PRO trials correctly. Says Engfer: "They've told you how to operationalize it. It's absolutely consistent with the work we've been doing with our PRO consulting division. You get your labels, you get your claims, you get your marketable drug."

For all the good news on the regulatory side, the picture on the hardware platform that underlies many industry projects is more dark. Like all of his competitors, Engfer has been observing the abandonment of corporate users by Palm as that company tries to survive superior consumer products from the likes of Research In Motion, Apple and Google. Engfer says that some Palm devices are holding up very well in trials that may take a year (or three) to complete. The company and its rivals are still provisioning trials using new and used Palm hardware, he says, using both existing inventory and an informal gray market in bartering and selling large numbers of handsets between sponsor firms that need them.

On a personal note, Engfer concedes, it's been difficult for him to watch Palm's declining interest in business customers, as he had known key people at the firm for a long time. "The guys we used to talk to at Palm, they are not there any more," he says. Looking ahead, though, Windows-based handheld devices may not have the cachet of an iPhone, but they will get the job done in clinical trials.

He says there are seven million users of Windows-based phones. Such people a) don't care that the Microsoft mobile brand is seemingly renamed every few weeks and b) have not yet been hypnotized by Blackberries or iPhones with reliability issues. As Palm supplies are exhausted, there is only one remaining name for enterprise-worthy mobile devices in clinical research. The firms supporting Windows, Engfer says, readily chat about durability, ease of use and total cost of ownership. Such mundane, real-world notions have probably never entered the cerebral cortex of Steve Jobs, at least as far as outsiders can tell. "Ultimately," Engfer notes, "we think the operating system is going to matter less and less."

Editor's note: This article has Quintiles' perspective on the invivodata deal.

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