BioCor brings image data to forefront of clinical trials

BioCor brings image data to forefront of clinical trials

PDAs, ‘Net enhance data collection, analysis

Diagnostic images are playing an increasingly important role in clinical trials of drugs and medical devices. Their widening use has prompted several contract research organizations (CROs), companies that specialize in running clinical trials, to begin offering image data capture and analysis services as part of their overall clinical development package.

Only one firm, however, has come up with an integrated image and information management system designed specifically for use in clinical trials. BioCor, a CRO founded in 1998 by some veterans of the diagnostic imaging industry, introduced the Alerion system in June as part of the company’s efforts to raise the standard for imaging data management in clinical trials.

“BioCor offers clinical development services to the pharmaceutical, biotech, and medical device industries,” said Andrew Kraus, president and cofounder. “We help vendors design their studies and collect and analyze the data from those trials. In this case, the data are not just clinical. Our twist is to also include the medical imaging data.”

Alerion incorporates features required for the complex task of managing imaging data into its clinical data management system. The Windows NT-based system provides user access control, audit trails, image log files, workflow processing, and automated verification of image acquisition parameters for built-in quality assurance. In addition, it integrates images, clinical documents, and SAS data sets by keeping the data in industry-standard formats (including DICOM, Word, PDF, and SAS) and taking an object-oriented approach to all data, regardless of whether they are image- or text-based. This method of integration eliminates the constraints imposed by proprietary file structures, a common problem within the clinical trial industry, according to Kraus.

“Clinical data services and core imaging laboratories have been viewed historically as two separate entities, but we are taking an integrated approach,” he said. “With Alerion, all these data can be looked at using industry-standard viewers, and we are implementing some of the same process controls on the imaging side that have long been standard practice in clinical trial data management systems. We are treating images as data, which is what they are.”

The Alerion system is operated out of BioCor’s headquarters in Yardley, PA. As data are collected during a clinical trial, they are sent back to BioCor for conversion and analysis, and the findings and data sets are then made available to the customer in nonproprietary formats. Customers are charged either on a per-patient, per-visit, or per-image basis. BioCor does not currently use an application service provider (ASP) model, but they are looking at eventually moving in that direction.

Kraus says several factors are driving the use of images in clinical trials. Foremost among these is the desire to shorten the length of a trial and the FDA review process. This reduces the time to market for a new product and translates into cost savings.

“There is a growing trend toward the acceptance of surrogate markers in clinical trials, and imaging can be a surrogate marker,” he said. “If you can confirm that you are decreasing the size of a tumor over the course of six months, and you can use an objective measurement (such as a CT or MR image) to reach that conclusion in far less time with far fewer patients, you go to market much faster.”

BioCor claims 15 customers, ranging from medical device and biotech firms to companies manufacturing diagnostic imaging agents. In addition, the company is beginning to work with large radiology groups that recognize the value of offering their image review expertise to any company involved in a clinical trial of a drug, device, or therapy.

“Most studies have a central image review process, where radiologists or blinded readers are looking at images in the absence of all other clinical data,” Kraus said. “There are some very well established radiology practices with revenue in the $100 million range, and they are seeing their revenue drop for several reasons. So where do they go to bring revenue back up? Clinical trials.”

BioCor is one of several companies building a business on the premise that new computer-based technologies can greatly improve the clinical trial process and dramatically improve a developer’s bottom line at the same time. A report put out by Andersen Consulting earlier this year noted that “the speed of the Web will soon transform clinical trials from laborious exercises in paperwork and patient recruitment into an efficient exchange of electronic communication, data analysis, and expedited regulatory agency review.”

“If you can cut a clinical trial down by even one day, that could mean $5 million or more in profits because the medication will be on the market sooner,” said Peter Knezevich, CEO of Omnicomm Systems, a Coconut Grove, FL-based firm that developed the TrialMaster Clinical Research System & Network, a Web-based software application designed to reduce the amount of paperwork traditionally associated with clinical trials.

One firm is combining behavioral science and handheld computing technology to collect and manage patient experience data for drug and device trials. invivodata, a start-up based in Scotts Valley, CA, has launched the first commercial version of invivosystem, a Palm-based electronic patient diary. The technology, developed at and licensed from the University of Pittsburgh, relies heavily on a branch of clinical psychology called Ecological Momentary Assessment, which uses self-assessment to yield more valid and reliable data.

“We offer an approach and a methodology that will revolutionize how clinical trials are conducted by creating accurate and valid measures for capturing patient experience in the real world, in real time,” said Doug Enfer, president and CEO of invivodata.

During a clinical trial, subjects carry a Palm computer that runs proprietary software customized by invivodata specifically for that trial. Information is collected in a variety of ways, including yes/no questions, picklists, and rating systems, all designed to facilitate patient interaction and compliance. The collected patient experience data include signs observed by the patient such as the number of asthmatic episodes, symptoms such as pain or anxiety, and quality of life.

“We also design in compliance markers that allow us to evaluate the value of the data,” said Jean Paty, one of the original developers of the University of Pittsburgh technology and now executive vice president of solutions development for invivodata. “We try to get good data from the start, and then we track patient compliance to ensure that the data are good throughout the life of the study.”

The data are regularly transferred back via the Internet to invivosystem servers, which are located at the company’s single data center in Pittsburgh. The data are then processed and analyzed and the results sent back to the clinic overseeing the trial, usually while the patient is still there with the doctor or healthcare provider.

invivodata is currently involved in three clinical trials and is in discussion with several other potential customers, primarily in the pharmaceutical industry. The company is also looking outside of clinical trials at home health and disease management applications for its technology.