Solutions

FileMaker Helps Further Cancer and AIDS Research Through Grey Healthcare Informatics

Grey Healthcare Informatics

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.

Overview

  • Before experimental drugs receive approval by the Food and Drug Administration (FDA), large–scale clinical trials must be performed by the pharmaceutical firm who created the drug. Pharmaceutical companies like SmithKline Beecham rely on Grey Healthcare Informatics to organize clinical trials of drugs — and Grey Healthcare, in turn, relies on FileMaker Pro.

Industry

  • Healthcare/Medical Services

Using the Protogé FileMaker database, I've helped doctors prepare an investigational letter of intent in 10 minutes that would normally have taken them the better part of an entire weekend to prepare using a standard word processor.

— William Flesher, RN and Manager, Clinical Trials Office, University of Rochester

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

Customer Benefits

The powerful, customized FileMaker Pro database contained in Protogé, supports and accelerates the protocol development process at every phase to help obtain and publish quality data quickly. 'Using the Protogé FileMaker database, I've helped doctors prepare an investigational letter of intent in 10 minutes that would normally have taken them the better part of an entire weekend to prepare using a standard word processor,' said William Flesher, RN and Manager, Clinical Trials Office at the University of Rochester.

'FileMaker Pro was selected because it was the best cross–platform database on the market,' said Don Stewart, Executive Vice President and Managing Director of Grey Healthcare Informatics. 'The Protogé solution was offered for Windows 3.1, Windows 95 and the Mac OS to clinical investigators.'

Using Protogé, doctors are now able to complete required forms in just minutes instead of weeks and, according to Aileen Silver, the American Cancer Society has called this solution, 'historic to oncology research.'

Protogé has also been very helpful for instructing clinical interns in the process of developing clinical protocols. 'Protogé is customizable, so it includes a lot of reference material and has been used for lectures on labeling, disease backgrounds and staging,' said Flesher.

For FileMaker:

Kevin Mallon
Public Relations Manager
FileMaker Inc.
408-987-7227
kevin_mallon@filemaker.com
http://www.filemaker.com

For Grey Healthcare Informatics:

Don Stewart
Grey Healthcare Informatics
212-886-3206
www.etrials.com