Software That Simplifies Protocol Development for Oncologists Available From SmithKline Beecham

September 1, 1997

Protogé, a first-of-its-kind software program that enables oncologiststo generate study protocols within a few hours rather than weeks, is now

Protogé, a first-of-its-kind software program that enables oncologiststo generate study protocols within a few hours rather than weeks, is nowavailable from SmithKline Beecham. Protogé simplifies the processof formulating complete protocols for clinical trials with its easy-to-usetemplate, built-in resource library, and fully automated, "intuitive"interface.

The new software is available to oncologists who are interested in conductingtrials with topotecan (Hycamtin), a SmithKline Beecham drug cleared bythe FDA in May 1996 for the treatment of recurrent, metastatic ovariancancer. SmithKline Beecham has supported more than 200 clinical trialsof topotecan and anticipates a rapid increase in the number of trials initiatedover the next few months with the launch of this new program.

"Oncologists typically spend a tremendous amount of time gatheringand synthesizing information to include in study protocols. Protogéwill acceler ate this process and ultimately increase the number of criticalstudies that can be initiated over a shorter period of time," saidScott 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 investigatorto create tailored protocols for small, single-center, noncomparative,phase I or II trial. Part I, Protogé Synopsis, allows the oncologistto create an "Investigator Letter of Intent" in just minutes.The investigator selects the drug(s) to be used in the study and then choosesthe appropriate route of administration, dosing, and cycles for each. Criticalinformation, 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 quicklyassemble a detailed protocol document for submission to SmithKIine Beecham,the FDA, and/or the investigator's institutional review board (IRB). Inaddition, Protogé contains an archive of appendices, including astandard patient consent form and a copy of the Helsinki Declaration, bothof 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 standardprotocol and ensures that the final document is complete. Resources thatcan be accessed with a click of the mouse include prescribing informationstatements (package inserts) for over 30 oncology agents, PDQ statementsfrom the National Cancer Institute, and background information for mostmajor cancers. Protogé also provides instant access to ProtogéPublisher, a guide created exclusively for Protogé users that listsrelevant journals and their publication parameters. Based on the investigator'stime frame, Protogé Publisher will generate a list of options forpublication.

Oncologists interested in obtaining this free software package shouldcontact 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 ClinicalInformatics, a division of Grey Healthcare, Inc.