FIRMS USING MORE TECHNOLOGY IN CLINICAL TRIALS
While most clinical trial sponsors continue to use paper data collection methods, more sponsors are using technology in their studies and recognize the need for electronic standards, according to a recent survey that included drugmakers and investigative sites.
There has been a "significant increase" in the use of electronic patient reported outcome (ePRO) technology and electronic case report forms (CRFs), said Dave Iberson-Hurst, CEO of Assero, a UK-based provider of tools for implementing the clinical trial industry's Clinical Data Interchange Standards Consortium (CDISC) standards. In 2004, these tools were implemented in 23 percent of trials, up from 19 percent in 2003, he said.
Drugmakers and sponsors of clinical trials believe CDISC standards will help speed regulatory approval and improve data exchange among partnering companies, the survey found. Trial sponsors also believe CDISC standards will reduce the effort required in making a regulatory submission, provide the basis for rapid agreement on standards within an organization and reduce the cost of data transfer, according to the survey, "Attitudes, Adoption & Usage of Data Collection Technologies and Data Interchange Standards."
Survey respondents included biopharmaceutical companies, CROs/service providers, investigative sites, technology service providers and consultants. The survey was conducted from October 2004 to January. More than half of the respondents had 10 or more years of experience, he said.
For more information about CDISC standards, go to http://www.cdisc.org (http://www.cdisc.org).