Nextrials Pulls Pulmonary Function Data into PrismBy Deborah Borfitz
Nextrials recently become the first electronic data capture (EDC) company to integrate pulmonary function data with other information routinely collected during clinical trials. EDC isn't just about zippier delivery of case report form (CRF) data, says CEO James Rogers. It's the ideal consolidation point for all study-related data.
The means for bringing pulmonary function readings into the mix was a partnership with Vitalograph, a Buckingham, UK-based respiratory technology firm. The motivator was a sponsor request that the two companies find a way for their data-capture systems to communicate, says Rogers.
Vitalograph manufactures a spirometry device designed for home use that measures pulmonary function and sends the results to a company-owned server for subsequent transmittal to study sponsors and clinical investigators. Some of that data will now flow into Nextrials' server and show up in its Prism clinical trial management system, says Rogers. On a nightly basis, Prism creates an extract of the combined data - from patient visits, Vitalograph tests, and the central lab - and forwards it to study sponsors.
The result is study data that can more easily be analyzed and reviewed by sponsors, speeding up the time between last patient visit and study closure. In the first study involving the new partners, the sponsor completed the data-cleaning process in less than two weeks because it had "faster access to all the data."
For purposes of integration, Nextrials has partnered with numerous central labs over the past two years, says Rogers. Unlike Vitalograph, some labs produce data that are already in accordance with CDISC (Clinical Data Interchange Standards Consortium) standards. "Integration of data is almost seamless," says Rogers.
With Vitalograph, it was a bit more work because its spirometry system produces data using SAS software, which has to be converted to XML (extensible markup language) and then put in CDISC ODM format for importation into Prism, says Rogers. It was a six-week program-writing project for Nextrials.
In 2007, the partnership is expected to increase by "three or four" the number of studies Nextrials does that involve the collection of automated lung function data, says Rogers. "Before this, there was nothing to distinguish Nextrials as the logical fit for pulmonary studies."
Sponsors have yet to request that MRI or CT data be displayed in Prism, says Rogers. But Nextrials "routinely imports this data and incorporates it into the nightly data extracts so there is a single source for all the study data."
Patient safety data has been integrated with Prism since initial release of the software in 1999. Both severe and non-severe adverse events are tracked, says Rogers, which is the ideal way to analyze a safety profile. Thesaurus coding software of Cerner Galt is employed to automatically convert descriptions of adverse events from verbatim to standardized terms, without which meaningful analysis of safety data would be "virtually impossible."
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Deborah Borfitz is a Vero Beach, Fla.-based freelance writer who previously contributed to the clinical trials publication CenterWatch. She is co-author of Informed Consent, covering the risks and benefits of volunteering for trials. She also writes extensively about healthcare trends, marketing, business development, and Internet intelligence.
InForm EDC Debuts in Mines of South AfricaBy Deborah Borfitz
Very few public health studies utilize electronic data capture (EDC). Few clinical research studies of any stripe involve wireless and offline data entry and remote location data management. Presumably, no study has ever randomized subjects according to the mine shaft they work in.That unlikely trio of events defines one of the latest projects of EDC solution provider Phase Forward. The Aurum Institute for Health Research, an independent public health organization renowned for its work in the fields of tuberculosis (TB) and HIV/AIDS, chose Phase Forward's InForm EDC solution for a landmark TB prevention study in which 64,000 South African gold miners are expected to participate, says Keith O'Leary, InForm's senior product marketing manager.
The aim of the study is to learn if the TB drug isoniazid, coupled with standard TB control practices used by the gold mining industry, more effectively reduces the incidence of the disease than the control program alone, says O'Leary. For the main trial, data will be collected for nine months from participants working in some of 21 different mine shafts, where limited or poor Internet connectivity is available, using InForm's "Unplugged" module. Up to now, the module has been used primarily on the laptops of clinical research associates for ease of monitoring at non-wired investigative sites.
For the Aurum study, sites collect data on laptops using a Web browser "as if in real time," and the information gets replicated on a synchronized basis over TCP/IP connections with centralized servers in Johannesburg, says O'Leary. "We're bending what people think of as the EDC market."
The so-called Thibela study is being conducted in collaboration with the London School of Hygiene and Tropical Medicine and the Johns Hopkins University Center for Tuberculosis Research. Funding comes from the Bill & Melinda Gates Foundation via the Consortium to Respond Effectively to the AIDS-TB Epidemic (CREATE), created by former South African President Nelson Mandela.
Training and recruitment for the study began in October 2005, and data collection began on the initial baseline study group in April 2006, says O'Leary. Ultimately, about 38,000 participants will be in the interventional arm of the main, two-year study.
TB, though curable, is often a death sentence for people with AIDS in South Africa due to diagnosis and treatment delays, says O'Leary. Gold miners are at particularly high risk for TB -- 80 percent are infected -- because of the high prevalence of silica dust in the mines that is linked to another risk factor for the disease. Computer models developed by the Aurum Institute suggest the regimen being tested could reduce the risk of TB in the research population by as much as 60 percent.
Rehabbed, mobile-home type structures serve as health centers at many of the mine shafts, where participants go for study visits, says O'Leary. A mobile x-ray van travels as needed to the various sites to collect medical images.
"One of the biggest hurdles was to get data entry staff [at the sites] computer savvy," says O'Leary. "A lot of them had never even seen a computer before, let alone used EDC. It was a major undertaking and it's going swimmingly."
This all goes to show, O'Leary adds, that InForm has a very user-friendly interface indeed. The latest iteration also has integrated reporting and analysis embedded in the product. The feature was "a deciding factor for Aurum."
Demand for more public health studies to fight epidemics is huge, says O'Leary. "In the future, a lot more of these types of studies will be sought out by public institutions across the globe."
Parexel's New CIO to Develop Integrated Technology PlatformBy Deborah Borfitz
Boston-based Parexel International, a global bio/pharmaceutical services provider, wants to develop an integrated technology platform for the benefit of clients across the development and commercialization continuum. Chief Information Officer (CIO) Christopher Rieder was recently hired to help make it happen.
Demand is growing among Parexel's client base for greater online collaboration across ever more complex global clinical development programs, says Rieder, who has more than two decades of IT experience. Many bio/pharmaceutical companies have several interfaces with Parexel, for consulting services, clinical research, and medical communications, as well as a variety of technology solutions offered by its Perceptive Informatics subsidiary.
"We will provide an integrated platform that allows clients to communicate seamlessly and to have greater transparency into their programs and our services," says Rieder. "Having enhanced access to data will allow our clients to make decisions even more proactively and effectively. From a technology perspective, we will assist clients with key aspects of their business, including technology...for adaptive clinical trials and to bring safe and effective treatments to market faster."
Creation of the CIO position has no connection to the failed TeGenero Phase I drug trial conducted in the UK last spring, says company spokesperson Jennifer Baird. The drug was intended to treat chronic inflammatory conditions and leukemia but instead seriously harmed all six participants. Parexel was exonerated in a subsequent investigation by the Medicines and Healthcare products Regulatory Agency, the UK medicines watchdog, and vowed to "facilitate access" to a TeGenero insurance policy available to compensate study volunteers.
Rieder says his overall goal will be ensuring Parexel "continues its success as a customer-centric solution provider, while adding a technology differentiator component to that focus." The publicly traded company operates globally with 54 offices in 40 countries and has more than 6,000 employees. Service revenue for fiscal 2006 was $614.9 million, with a record $1.1 billion in backlog.
Moving forward, Parexel will be exploring opportunities with outside technology vendors that have a similar customer-centric viewpoint and experience in servicing the bio/pharmaceutical industry, says Rieder. Specifically, it will be looking at "top-tier vendors" that focus on integration, provide single-solution capabilities, and have managed large initiatives "with a global approach."
Rieder will apply the vendor-based decision processes he gained from his previous experience in managing global IT organizations in the bio/pharmaceutical industry. Most recently, Rieder was vice president of information technology at Kos Pharmaceuticals. He held similar positions at BRI International, a contract research organization (CRO), and at North American Vaccine, a provider of pediatric and adult vaccines.
A contributing author to a book about maximizing returns on technology investments, published in 2006, Rieder follows "a best practice model that ensures clients are participating in the process from beginning to end, which also results in a high degree of client satisfaction and repeat business."
Among CROs of all sizes, appointing a CIO or otherwise "elevating IT" is now viewed as a competitive imperative, says Rieder. "CIOs need to take a more corporate point of view versus an operational point of view, and also implement a long-term strategic vision to use technology for greater success in their own businesses as well as for their clients' businesses. They need to ensure that data is more readily available to clients and that technology is flexible, adaptable, and scalable to meet a range of client needs."
