There's a race on to cure cancer and other catastrophic diseases such as AIDS, and a FileMaker Pro based database solution is helping physician researchers in their pursuit of better treatments. Before an experimental drug receives approval by the Food and Drug Administration (FDA), arduous, large–scale clinical trials must be performed by the pharmaceutical firm. But there is another important avenue of research that further defines the potential usefulness of a drug. Individual investigators, working on their own under the sponsorship of governmental organizations and pharmaceutical companies, conduct countless small studies of their own design. Despite smallness of size, these trials can yield highly suggestive results, which can then be the basis for further, large–scale investigations.

Business Challenge

Conducting research in human beings, even in small trials, is a serious business. No trial can proceed — even one in a single hospital center with just 30 patients — without a so–called clinical protocol. A protocol is essentially a detailed description of every aspect of the study:

• The purpose of the study
• The type of patients to be entered
• How patients are to be treated and evaluated, etc.

Much of the protocol consists of background information and regulatory boilerplate. The protocol writer must search far and wide for the information to assemble a complete document.

Clearly, developing a clinical protocol is not an easy task. Protocols for even small studies can run from 20 to 100 pages in length and can takes weeks, if not months to complete. Often the sheer labor required in writing a protocol significantly delays, and sometimes derails an important study, even when funding is available. In some cases, the protocol will be incomplete and poorly conceived, resulting in sub–standard data unworthy of publication.

Successful Solution

To solve this time and money drain on resources, Grey Healthcare Informatics has developed a comprehensive program called Protogé, which stands for Protocol Generator. Protogé brings together an enormous amount of information in one place to streamline the protocol development process. Actually, Protogé helps the independent investigator do two things: Create a proposal (or 'letter of intent') outlining his or her proposed study in order to obtain funding, and 2) Assemble the detailed clinical protocol needed to implement the study. Protogé has been used by numerous pharmaceutical companies to help support independent investigators, including SmithKline Beecham.

Grey Healthcare Informatics worked with Aileen Silver, a FileMaker Pro developer to create a customized solution runs on FileMaker Pro for Windows 98, Windows 95, Windows NT, Windows 3.1 and Mac OS, the award–winning database from FileMaker, Inc.

Protogé is a little like software that prepares a tax return or writes a will. You fill out a detailed form, aided by drop down menus and dialogue boxes, and presto, a detailed document is generated that meets demanding legal or regulatory requirements.

In essence, the Protogé database allows the investigator to specify numerous study parameters, e.g., the type of disease being studied, the drugs to be administered, the study objectives, patient inclusion and exclusion criteria, etc. Each selection taps a huge database that automatically deposits relevant information into specific sections of a highly structured protocol. Protogé also includes an electronic subset of the Physicians Desk Reference, a leading physician resource which documents pharmaceutical agents.

FileMaker Pro was selected because it was the best cross-platform database on the market.

— Don Stewart, Executive Vice President and Managing Director, Grey Healthcare Informatics