T H E   N I H   C A T A L Y S T     N O V E M B E R   –   D E C E M B E R  2003


Robert Nussenblatt

According to Bob Nussenblatt, it’s a "very smart" package.

"It knows the format to use for the various institutional review boards.

"It asks you what kind of study you’re doing, and if you click on to ‘interventional,’ it will ask a series of questions to determine if you need an IND [investigational new drug].

"In most cases, you will—and when that occurs, there will be another module with a form to fill out for the IND submission [to the FDA]. And much of that form will be prepopulated with the information you already put into the clinical protocol.

"It has links to important regulations. And you won’t have to worry that you’re doing something with rules that expired three years ago, or that you’re missing some form that is now necessary.

"Everything we could think of is under one roof."

That roof is ProtoType, a web-based software program that standardizes the framework for writing a clinical protocol but does not box the PI in to rigid descriptions of the nature of the research. Among the menu items is IC selection, so that if there are any institute-specific protocol requirements, the appropriate format will be offered. ProtoType will be available to the intramural community by year’s end—at this website.

The builders of ProtoType are Nussenblatt, chief of the Laboratory of Immunology, NEI, and director of the CC Office of Protocol Services, and a "small group" of NIH clinical investigators and administrators who "all saw the need for more standardization but with continued flexibility"—as well as the desirability of being able to capture electronically the evolving protocol in all its iterations as it goes through the various levels of of review and revision. The program also automatically alerts the PI to any information gaps and guides the user on how to include the missing piece before proceeding.

The idea, Nussenblatt says, is to provide the PI with a more rapid and better way to do things, minimizing the chances of overlooking some crucial bit of information that will delay protocol approval and also enabling better tracking of patient status once the trial gets going, a safety feature.

A reporting system for adverse events is built into ProtoType, enabling the investigator to keep accurate records of these findings and also ensure that the wording is right. "The goal," Nussenblatt says, "is that required adverse event reports go directly to the relevant agencies, such as the FDA if an IND is involved, and in the right time frame, which varies depending on the severity" of the adverse event.

Using ProtoType is not now viewed as a prerequisite for conducting clinical trials at the CC. "It’s not mandatory, but we’re hoping that investigators will see it as counterproductive not to use ProtoType. There are just so many positives, it’s hard to guess why someone would choose not to," Nussenblatt observes.

The prototype for ProtoType had been germinating for about two years, beginning with discussions between Nussenblatt and CC director John Gallin and gradually including other clinical investigators at NIH whose experiences in writing clinical protocols and conducting clinical trials at the CC informed their opinions on how the protocol-writing process could be improved. "The product is definitely a reflection of what clinicians wanted," Nussenblatt says, "and as it turned out, it also harmonizes very well with the international committee on harmonization of all aspects of clinical protocols and clinical trials."

For ProtoType’s journey from vision to reality, Nussenblatt hastens to credit Kim Jarema, chief of the Office of Protocol Services; Steve Rosenfeld, chief of clinical research informatics; Elaine Ayres, ProtoType project officer, and, especially, Gallin.

In his closing remarks at the day-long symposium celebrating 50 years of CC clinical research, Gallin referred to ProtoType as the answer to investigators who have come to his office saying that they "would like to do clinical research, but it’s just too hard." ProtoType, he noted, will hook into the new Clinical Research Information System, the informatics arm of the new Clinical Research Center (see Guest Editorial, The NIH Catalyst, November-December 2002).

The future of clinical research at the CC, Gallin observed, "is now."

Fran Pollner



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