|TH E N I H C A T A L Y S T||S E P T E M B E R O C T O B E R 2008|
ProtoType, the Web-based clinical protocol writing system nearly eight years in the making, entered a new phase in September, greatly expanding its features to integrate a seamless submission process with NINDS's Protocol Tracking Management System.
The combined features of the two systems make ProtoType the most comprehensive tool available to clinical researchers confronted with the daunting task of writing a successful protocol.
Yet to call ProtoType an authoring tool sells the system short, says Clinical Center Director John Gallin, who had championed the concept since its incarnation circa 2000. ProtoType attempts to ease every step in the clinical protocol process, from crafting the protocol language, onward through the checklist of policy regulations specific to your research objectives, through reviews and revisions, and to adverse-event reporting and data sharing.
ProtoType, available to all NIH scientists, was created by protocol-writing pros who understand the pitfalls inherent in the process. They themselves have stumbled into them. Their goal was to create a user-friendly interface that would minimize guesswork and standardize the process, yet maximize flexibility. The system, updated continually, tracks institute-specific protocol requirements but never confines the principal investigator to narrow descriptions of their research.
"ProtoType was homespun by NIH investigators who envisioned a system that would handle all aspects of the protocol life cycle," said Philip Lightfoot, a systems analyst in the Department of Clinical Research Informatics and a primary contact on the ProtoType development team.
The ProtoType concept evolved from casual discussions between Gallin and institute clinical investigators. In 2002 Robert Nussenblatt, chief of the NEI Laboratory of Immunology, became very interested and assumed a leadership role in the development of a working "prototype" of ProtoType by 2002, used by NEI.
Word spread, and constructive input poured in. The most significant input came over the past year, as a major beta-testing effort by Barbara Karp, chair of the new neurosciences IRB, greatly improved ProtoType, making it more user-friendly with import features such as a robust reference manager, the ability to cut and paste figures, and the ability to send the protocol to the IRB and the Scientific Review Committee.
September marked the transition from beta-testing to the upgraded ProtoType's public debut.
Other features in ProtoType include an Investigational New Drug application "wizard" built with input from the FDA, automated filling of the Clinical Research Protocol Initial Review Application form (form 1195), a standard-language repository, rapid integration of NIH and other federal policies, an image library, an informed consent manager, ability to draft letters to referring physicians, ease of accommodating collaborations among intramural and extramural researchers, feedback and comment systems for coauthors and reviewers, the ability to view the full history of the protocol, the ability to compare protocols at different dates, and, of course, the possibility of keeping the protocol paperless. Best of all, the program alerts the PI to any information gaps and guides the user on how to include the missing piece before proceeding.
ProtoType eventually will be used for adverse-event reporting, mapping research and projecting resources and will be linked to the Biomedical Translational Research Information System (BTRIS), making BTRIS a system that not only organizes data that has been collected but also data planned to be collected. ProtoType and BTRIS will assist investigators in registering protocols and reporting required outcome measures into ClinicalTrials.gov.
Other promising possibilities are the capacity to produce toxicity reports and alert PIs of trends in experimental treatments. Gallin spoke of interest in ProtoType outside of NIH, because there are no other systems like this.
CC Director John Gallin
Members of the extensive, multi-institute ProtoType development team: Kimberley Jarema, Philip Lightfoot and Ryan Kennedy
ProtoType is not mandatory, but Gallin said there are so many positive aspects of the system that it would be counterproductive not to use it, even for veteran clinical researchers. In the past month 25 investigators have been trained in using ProtoType and 14 protocols are using it, in NEI, NIAAA, NIAID and NINDS. The large team behind ProtoType includes Kimberley Jarema, director of the Office of Protocol Services, who has been part of its development since the beginning.
Lightfoot briefed the NIH scientific directors on October 1, explaining how ProtoType will not show all of its value upon first use. "This is a tool built to grow with the investigator and their protocols," he said.
When you first start using it, ProtoType presents all of the data that the NIH and your IRB would like you to know regarding how to write a protocol. As you write the first protocol, you start to build your own language for procedures, your own image library and your own references. These data are then at your fingertips for the second protocol. By the third and fourth protocols, a snowball effect takes place. And when you perform yearly continuing reviews and amendments, all the information that has changed is right there for your IRB and for your collaborators.
Does ProtoType really live up to the hype? The only way to know is to try, and then provide Lightfoot and Jarema with feedback to make the system better. Prototype resides at http://prototype.cc.nih.gov.
—additional reporting by Eric Schaffer