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(TM) 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(TM)), clinical
data management (Clintrial(TM)), clinical trials signal detection
(CTSD(TM)), strategic pharmacovigilance (WebVDME(TM) and Signal
Management), adverse event reporting (Clintrace(TM)) and applied data
standards (WebSDM(TM)). 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.
