Protogé, a first-of-its-kind software program that enables oncologists to generate study protocols within a few hours rather than weeks, is now available from SmithKline Beecham. Protogé simplifies the process of formulating complete protocols for clinical trials with its easy-to-use template, built-in resource library, and fully automated, "intuitive" interface.
The new software is available to oncologists who are interested in conducting trials with topotecan(Drug information on topotecan) (Hycamtin), a SmithKline Beecham drug cleared by the FDA in May 1996 for the treatment of recurrent, metastatic ovarian cancer. SmithKline Beecham has supported more than 200 clinical trials of topotecan and anticipates a rapid increase in the number of trials initiated over the next few months with the launch of this new program.
"Oncologists typically spend a tremendous amount of time gathering and synthesizing information to include in study protocols. Protogé will acceler ate this process and ultimately increase the number of critical studies that can be initiated over a shorter period of time," said Scott Fields, md, oncology group director, SmithKIine Beecham Pharmaceuticals.
A Two-Part Program
Protogé, which is compatible with Macintosh, Windows 3.1, Windows '95, and Windows NT, is a two-part program that enables an investigator to create tailored protocols for small, single-center, noncomparative, phase I or II trial. Part I, Protogé Synopsis, allows the oncologist to create an "Investigator Letter of Intent" in just minutes. The investigator selects the drug(s) to be used in the study and then chooses the appropriate route of administration, dosing, and cycles for each. Critical information, such as dose escalation, study population, per patient costs, and study end points (including pharmacoeconomic and quality-of-life), are easily entered.
Part 2, Protogé Prototype, permits the investigator to quickly assemble a detailed protocol document for submission to SmithKIine Beecham, the FDA, and/or the investigator's institutional review board (IRB). In addition, Protogé contains an archive of appendices, including a standard patient consent form and a copy of the Helsinki Declaration, both of which can be easily copied into the document.
Easy Access to a Wealth of Medical Resources
Protogé stores information that is used to enhance a standard protocol and ensures that the final document is complete. Resources that can be accessed with a click of the mouse include prescribing information statements (package inserts) for over 30 oncology agents, PDQ statements from the National Cancer Institute, and background information for most major cancers. Protogé also provides instant access to Protogé Publisher, a guide created exclusively for Protogé users that lists relevant journals and their publication parameters. Based on the investigator's time frame, Protogé Publisher will generate a list of options for publication.
Oncologists interested in obtaining this free software package should contact their local SmithKline Beecham oncology medical associate (OMA) or Charlie Agius, PhD, Manager, Special Projects, SmithKline Beecham, at (215) 751-5910 (e-mail: charles.agius@sb.com).
Protogé was developed for SmithKline Beecham by Phase V Clinical Informatics, a division of Grey Healthcare, Inc.
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