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Phase Forward's InForm EDC Solution Implemented By Aurum Institute for Large-Scale Tuberculosis Study in South Africa

Posted on: Wednesday, 18 October 2006, 12:01 CDT

Phase Forward International Users Conference -- Phase Forward (NASDAQ: PFWD), a leading provider of data management solutions for clinical trials and drug safety, today announced that the Aurum Institute for Health Research has implemented the company's InForm™ Integrated Trial Management software for Electronic Data Capture (EDC) for a landmark study of tuberculosis (TB). As part of a global research program to use preventive therapies to reduce the incidence of the disease, 60,000 South African gold miners are expected to participate. Dr. Dave Clark, executive director, Aurum Institute for Health Research, will deliver today a keynote address at Phase Forward's International Users Conference in Las Vegas.

The study, launched in October 2005, is led by the Aurum Institute in collaboration with the London School of Hygiene and Tropical Medicine and the Johns Hopkins University Center for Tuberculosis Research. The project is backed by the South African Mine Health and Safety Council and operates as part of the Consortium to Respond Effectively to the AIDS-TB Epidemic (CREATE), which is funded by the Bill & Melinda Gates Foundation. CREATE aims to research novel public health interventions to reduce the burden of HIV-related TB at the population level.

Former South African President Nelson Mandela launched the CREATE project in July 2004 at the International AIDS Conference, with the following remarks: "...we cannot win the battle against AIDS if we do not also fight TB. TB is too often a death sentence for people with AIDS. It does not have to be this way. We have known how to cure TB for more than 50 years. What we have lacked is the will and the resources to quickly diagnose people with TB and get them the treatment they need."

Dr. Clark commented on the Thibela study: "A TB study of this magnitude is a first. After evaluating a number of options, we selected Phase Forward's InForm product as the EDC engine for this study based on its proven scalability in large trials and usability in developing countries, as well as Phase Forward's ability to meet the timelines of the study. Our first pilot study went live on schedule in April and the main study started in July, with 477 participants recruited within the first two weeks. We've been impressed with Phase Forward's flexibility and dedication to delivering results in a short timeframe."

"Phase Forward is pleased to play a role in a study with such important public health implications," said Bob Weiler, president and CEO, Phase Forward. "We look forward to supporting the Aurum Institute on this project, which has considerable potential for improving lives and changing global policies."

Background on the Study

The objective of the study is to compare the efficacy of nine months of TB preventive therapy using the TB drug isoniazid in addition to the standard TB control program practice used by the gold mining industry, against the effectiveness of the standard control program alone.

The program involves an initial baseline study that includes approximately 17,000 participants. Data is being collected from up to 100 participants per day from 20 mining sites for 12 months. The main study, which is expected to include 38,000 participants in the intervention arm, will be conducted over a two-year period at 20 primary mine locations and health centers.

The studies will be conducted on a paperless basis, with all data being entered at remote sites. The project relies on InForm's "Unplugged" module, which supports wireless and offline data entry and remote location data management. Patient data collected at the 20 mining sites is being replicated daily with Aurum's servers in the Central Hosting Facility in Johannesburg.

The study name, "Thibela TB," translates from the South African Southern Sotho language as "Prevent TB." In spite of intensive TB control programs, the incidence of the disease in South Africa's gold miners in recent years has more than doubled. Computer models developed by the Aurum Institute along with prior evaluation of the medication suggest that the regimen being tested could reduce the risk of TB in the research population by as much as 60 percent, according to the Institute's CEO, Professor Gavin Churchyard.

About Phase Forward

Phase Forward is a leading provider of integrated data management solutions for clinical trials and drug safety. The company offers proven solutions for electronic data capture (InForm™), clinical data management (Clintrial™), clinical trials signal detection (CTSD™), strategic pharmacovigilance (WebVDME™ and Signal Management), adverse event reporting (Clintrace™) and applied data standards (WebSDM™). In addition, the company provides services in the areas of application implementation, hosting and validation, data integration, business process optimization, safety data management and industry standards. Phase Forward's products and services have been utilized in over 10,000 clinical trials involving more than 1,000,000 clinical trial study participants at over 230 organizations and regulatory agencies worldwide including: AstraZeneca, Boston Scientific, Dana-Farber Cancer Institute, Eli Lilly, Food and Drug Administration, GlaxoSmithKline, Merck, U.K. Medicines and Healthcare Products Regulatory Agency, National Institutes of Health, Procter & Gamble, Quintiles, sanofi-aventis, Schering-Plough Research Institute, Serono and Servier. Additional information about Phase Forward is available at www.phaseforward.com.

About the Aurum Institute for Health Research

The Aurum Institute for Health Research is an independent medical scientific organization for the treatment of and research into epidemic and other diseases in developing countries. The negative impact of the poor understanding and management of these epidemics is vast, affecting individuals, communities and economies. The recognition of the huge advantages of controlling these diseases is Aurum's motivation. Aurum has an international reputation for its work in the fields of tuberculosis and HIV/AIDS, and is the recipient of research and other grants from South African and international agencies and institutions for this work. Additional information about the Aurum Institute is available at www.auruminstitute.org. Additional information about CREATE is available at www.tbhiv-create.org.

Certain statements made in this press release that are not based on historical information are forward-looking statements which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. This press release contains express or implied forward-looking statements relating to, among other things, the performance and features of Phase Forward's products and services, future business and operations plans of a Phase Forward customer, and the ability of Phase Forward's customers to realize benefits from the use of Phase Forward's products and services. These statements are neither promises nor guarantees, but are subject to a variety of risks and uncertainties, many of which are beyond Phase Forward's control, which could cause actual results to differ materially from those contemplated in these forward-looking statements. In particular, the risks and uncertainties include, among other things, the ability of Phase Forward's customers to realize benefits from the use of its products and services, and the possibility that customers' needs or plans may change over time. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Phase Forward undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise. For additional disclosure regarding these and other risks faced by Phase Forward, see the disclosure contained in Phase Forward's public filings with the Securities and Exchange Commission including, without limitation, its most recent Annual Report on Form 10-K.

Source: Business Wire

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