By Deborah Borfitz
January 20, 2009 | A web portal, recently rebuilt on Microsoft’s popular SharePoint platform, is being used to streamline the review of cystic fibrosis (CF) clinical trial protocols and facilitate collaboration among those who propose and conduct them.
The portal, known as CF ClinicalResearchNet, is hosted and funded by Cystic Fibrosis Foundation Therapeutics, Inc. (CFFT), a division of the national CF Foundation. It is fully accessible to research centers that are part of the CFFT Therapeutic Development Network (CFFT TDN), says Natalie Beauchene, operations project manager of the network’s coordinating center housed at Seattle Children’s Hospital.
The CFFT TDN originated in 1998, with eight centers, to facilitate the clinical study of new therapies for CF, says Beauchene. For the first several years, protocol reviews were conducted via email. That was cumbersome because the files were large and downloads were sometimes impossibly slow. “Some study sponsors expressed concerns about the security of their information.” Moreover, protocol reviewers didn’t know what anyone else had to say, so “the process wasn’t very collaborative and editing all the comments was pretty grueling.” Keeping track of which reviewers had and hadn’t submitted their responses could also be tedious, she adds.
An earlier, custom-built website met some of these needs. But because most features were static and couldn’t be directly modified, even by the coordinating center, the website had limited use beyond document sharing and protocol review, says Beauchene.
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| Natalie Beauchene |
Membership in CFFT TDN jumped from 18 to 77 centers nationwide at the end of 2008 in response to substantial growth in the size and number of CF studies, says Beauchene. Fortunately, the new web portal was already in place to better support the network’s changing needs, including “better sharing of information and tools to facilitate efficiency and quality in CF clinical research.”Protocols are posted on the new site and accessible only by their assigned reviewers, a happy turn of events from the standpoint of sponsors, Beauchene says. Protocol review is now a collaborative online affair, “so we end up with better thought-out [studies]” that are not unnecessarily lengthy, risky, or difficult to recruit for. “The ability of the new portal to centralize all information around a protocol reduced the flurry of emails and document attachments that were previously necessary throughout the process.”
With the launch of CF ClinicalResearchNet in April 2008, user groups can be established and permissions granted, down to the document level, without vendor assistance. Coordinating center staff can easily add new features and modify existing pages independently and give permissions to others to do the same, says Beauchene. Individual users can also opt to receive email “alerts” of new content added to specific areas of the portal, such as the library or calendar, to save themselves a trip to the site to find the information.
Jill VanDalfsen, director of network operations and development at the CFFT TDN coordinating center, says the biggest benefit of the portal is that it gives her a place to direct users with routine inquiries, such as the projected start date of a new study or appropriate reimbursement for study subjects.
The portal is currently being used by about 800 CF clinical research professionals, including investigators and coordinators from over 100 CF research centers. There is a user group and customized tools not only for the protocol review committee, but also the steering committee that reviews network policies and the clinical research executive committee that handles final protocol review, says Beauchene. Each has its own pages on the portal for independently posting and sharing documents, holding discussions, and establishing meeting dates and times. The intent is to give similar online review tools to committees for publications and National Resource Centers, specialized labs that review proposals for ancillary studies.
Committee administrators are reaping tremendous time savings from the portal, says Beauchene. “Reviewers’ comments are entered into the database [on the site’s back end] by category, so administrators get reports that are organized by question or topic.” Commentary can be edited in minutes rather than days. In the near future, further efficiency will be realized by automatic reminders sent to reviewers who are slow to respond.
On CFF-funded trials, where the coordinating center serves as study manager, sites will be directed to a repository on CF ClinicalResearchNet to fetch all the necessary forms and documents, says Beauchene. In the past, a third party was paid to compile and deliver the appropriate documents to sites.
All of the development work for the portal was done by Seattle-based Cypress Consulting, a Microsoft Gold Partner.