The actual cost of drug development is a matter of debate, since companies are stingy when it comes to releasing data. But one things certain: its not cheap. According to an estimate made last year by the Tufts Center for the Study of Drug Development, the cost of bringing a drug to market is $897 million dollars. Late last year, the consultancy Bain & Co. Inc. used different assumptions and upped the estimate even higher, to $1.7 billion.
Industry experts attribute most of the expenses to clinical trials. In these multiyear studies, huge volumes of data are collected from patients, often by clinicians working at more than a dozen sites.
Not surprisingly, theres a large market for products and services that claim to make clinical trials more efficient. These include several kinds of so-called e-clinical services such as electronic-data capture, interactive patient enrollment and Web-based trials management. As these services grow in use and number, professionals need ways that keep their applications—and their team members—working together. But until recently, one potential solution has been consistently underused: namely, the World Wide Web.
Thats changing, says Sandor Schoichet, senior consultant at Zoomedia Inc., a firm that helps life sciences companies use Internet communications effectively. Schoichet, formerly director of information sciences at Genentech Inc. and CIO at Gorilla Genomics, says he is seeing more companies starting to use so-called clinical portals. He defines these as a special type of Web site that helps members of a geographically dispersed team to work together by providing “integrated, secure and personalized access to … databases, documents, applications and collaboration services.”
Portals slow in coming
to clinical trials”>
Portals are already common in various industries. Salesforces use them to track leads, assemble proposals and report pipelines. Help desk portals allow users to access frequently asked questions, find current documentation and track clients. However, sponsors of clinical trials have been slow to establish clinical portals. One reason is that no one is sure who should take charge of a portal. While a companys IT department already may have established a portal for commercial applications, clinical IT groups are often separate from corporate groups, making their portal projects separate as well.
Another factor clouding the question of who should take care of a clinical portal is that clinical IT groups tend to focus on collecting data—not sharing information about a given projects status. In addition, the FDA guidelines known as 21CFR11 require that any software undergo extensive evaluation to ensure data integrity, and clinical IT groups are leery of any new technologies that have not already gone through this testing. 21CFR11 can have a chilling effect on innovation, in that IT groups tend to be so concerned with transmitting compliant data that they stay away from software that isnt 21CFR11-approved, even if the software wont be used to present data.
This means that clinical IT groups overlook well-supported commercial software, even though portals shouldnt present problems with data integrity, Schoichet said, since “much of what the portal would be concerned with would be for collaboration, not data.”
Thats unfortunate, says Schoichet, since portals can make product development run much more smoothly. For example, the use of portals means that no one has to mail documents out for review. Also, checking to see who has read updates is straightforward—requiring, for example, a simple automated query to list who had downloaded documents, thus reducing to a few key strokes what now requires a few telephone calls. In addition, no one has to scroll through e-mail for the most current development plan or protocol, since the portal displays the most current versions. Indeed, such advantages have already led CROs (clinical research organizations) to implement what Schoichet calls the beginnings of portals.
For example, a CROs portal would be used to let a clinical sponsor know whether data had been collected or whether a trial site had enrolled enough patients. This means a CRO could catch and fix snags earlier. But the usefulness of CRO-based portals is limited, since these portals focus on individual trials. Pharmaceutical companies need to focus on the end product or drug, which typically requires several clinical trials, often run by a combination of in-house and CRO teams.
The promises of portals
The biggest advantage of a clinical portal for a pharmaceutical company, says Schoichet, is that it ensures that all participants are working on the same project. If versions of the draft label—which lists the conditions, such as flu in patients between 5 and 55 years of age, for which the company is allowed to say the drug can be used—for which FDA approval is being sought were available on a portal, then clinical, regulatory and marketing groups could be sure that the launch plan fits how the drug or therapeutic can be promoted legally.
Often, a marketing team realizes that its clinical team has been developing something other than what it needs to sell only as a product submission deadline looms. Such a mismatch may force the marketing team to seek last-minute changes in carefully thought-out plans or force the clinical team to rework detailed analyses to support additional label claims, thereby possibly straining relations and credibility with the FDA.
Though issues of security and user interfaces are not trivial, Schoichet says that implementing the technology is much simpler than most other e-clinical services. The technology is, essentially, a Web site, and it can be implemented by an outside service provider or a companys IT group. Several of the big players offer products, including Microsoft Corp.s SharePoint, Open Text Corp.s Livelink, IBMs WebSphere and Oracle Corp.s Application Server Portal. Plumtree Software Inc. is considered the leading independent portal vendor, and First Consulting Group, which presented its wares at a recent industry conference, has built a group of custom clinical portals. Zoomedias WebCenter, basically a lightweight project extranet that works as a project collaboration portal, provides a low-cost alternative for smaller biotechs.
More difficult than implementing the technology can be establishing a corporate culture that will embrace the technology, according to Schoichet. Clearly, if all the right information isnt put into the portal, or if the portal information isnt kept current, no one will use it. Too frequently, companies assume that a portal will be self-maintaining once its established. The most important factor in a portals success, Schoichet noted, is that a senior product development manager is put in charge of it. Someone has to make sure that all the right documents are available and that the system can be used to track who has checked for updates and signed off on reports. Drug development requires the participation of a wide variety of independent groups, and the portal owner must have the authority to ensure that they are collaborating effectively.