Cosmo Technologies Uses Datatrak EDC in Clinical Trials
Cosmo Technologies, an Italian pharmaceutical company specializing in gastrointestinal drugs, has made a first-time move into electronic data capture (EDC).
The firm selected Datatrak International’s EDC Version 4.0 software for two of its Phase III clinical trials. The two clinical trials together involve 230 users at 110 sites and will seek to enroll 650 patients in Europe and the Americas.
“This is the first time we [have] conducted a Phase III clinical study,” Federica Castelli, executive assistant to Mauro Ajani, Cosmo Holding’s chairman and CEO, told PIR. “The advantages Cosmo foresees from using Datatrak [are that] a constant monitoring of data emerging from the treatment of patients will help us save time and money.”
For the Italian company, this marks an initial conversion from a paper-based recordkeeping system to EDC, said Jeffrey Green, president and CEO of Datatrak. “This is their first entry into EDC and it sounds like they are going to move forward with an electronic platform.”
The advantages for Cosmo are manifold, Green said. Considering that the sites for the two clinical trials are spread over three continents, “this is the only way they can see their data in real time.” It will also result in massive cost savings, he said.
The product was recommended by an affiliate company, Cross SA, a Swiss contract research organization (CRO), Castelli explained. The CRO is managing the clinical trial for Cosmo, and its support for EDC marks it as progressive in its field, said Green. “CROs make money pushing paper, so it completely changes their business model,” he added.
Green said he had testified before an FDA advisory panel on May 19, 2005, about the necessity of moving from paper-based to EDC systems for clinical trials. While using EDC doesn’t directly speed up the FDA approval process, “it allows you to get data to the FDA faster,” he said. In fact, the agency is somewhat ahead of private industry in requiring electronic submissions, he said.
But even that has not been enough to overcome institutionalized resistance to phasing out paper records. “It would make no sense, but people could do the trial on paper and then put it into electronic format,” Green said.
Paper Threat to Patients
The reliance on paper records in clinical trials can be seen as an anachronism even in the pharmaceutical industry’s own terms, since other corporate functions are fully computerized. “I usually tell the industry that they track their sales revenues usually every Friday by zip code,” Green pointed out.
“If you come in to do the same thing every day for years, EDC ‘disrupts’ your routine by speeding it up,” Green said. Being a former clinician himself, he understands the resistance to giving up paper records, “but if your hesitancy to change is harming the patient, you have to draw the line,” he said.
That is exactly the point that has been reached in clinical trials today, he argued before the FDA advisory panel last May, since the delay in amassing paper records can lead to a delay in the discovery of potentially harmful side effects in experimental drugs. “It’s a hazard to the patients’ safety. With paper, it takes six to nine months for the data to get from the doctor’s office into the relational database for adverse events … What I told the FDA is, you can’t react to what you don’t know.”
Green stressed the considerable financial savings to be had by implementing EDC. “In our business model, there is no licensing fee up front, but there are huge cost savings,” he stated. — Martin Gidron