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 datanot 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.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 straightforwardrequiring, 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. Next page: Portals promise smoother workflow.
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."