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"
The new software is available to oncologists who are interested in conducting
trials with 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
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: firstname.lastname@example.org).
Protogé was developed for SmithKline Beecham by Phase V Clinical
Informatics, a division of Grey Healthcare, Inc.