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 labelwhich 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 usedfor 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.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.
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.