Use of electronic data capture and management (EDC) software for clinical development is still in its infancy, but there are signs that the sector is evolving with the number of trials making use of EDC almost doubling between 2000 and 2004, according to a new market research report from Kalorama Information.
EDC allows direct data entry from trials into electronic format and have the potential to reduce time and money spent on the drug development process, making it easier to share data within and between organisations.
The author of the report, Anne Anscomb, told PharmaTimes that the EDC market had been held back by the fact that most available systems are stand-alone and do not meet the objective of creating a fully-automated clinical development process.
This has pegged back the market for EDC in drug development to around $300 million, she said, although vendors are gradually integrating a number of related processes, from protocol development, site initiation, and subject enrollment to data collection, monitoring, analysis, and regulatory submission, that will broaden the appeal of their products.
In addition, the adoption of new data standards by regulatory agencies is lending additional momentum to the market’s development, said Anscomb. For example, the US Food and Drug Administration (FDA) has provided guidance for submissions using the Study Data Tabulation Model developed by Clinical Data Interchange Standards Consortium (CDISC) and has accepted CDISC’s Operational Data Model for data interchange and archiving.
Meanwhile, the pharmaceutical industry is starting to carry out longer, more complex safety and efficacy studies to satisfy regulators and pursue the development of products for disease prevention.
“Industry experts believe the increased safety testing done in Phase IIIb and IV trials, which increases the complexity of the studies and the complexity of working with large numbers of sites, will drive the change...for EDC adoption,” according to the report.
For example, CenterWatch , an information source for the clinical trials industry, estimated that in 2004 companies used EDC for 44% of their Phase I-IV trials, more than double the proportion four years earlier.
According to the FDA, standards being developed by CDISC are the centerpiece of the agency’s vision for an information technology (IT) infrastructure that can improve clinical development.
Some of the leading vendors including Phase Forward, Oracle Clinical, NexTrials and Medidata. And although some CROs offer EDC solutions, not all have developed proprietary solutions nor have they signed contracts with EDC providers. Thus at present, CROs are currently in a competitive situation with EDC vendors, according to Anscomb.
More information about the report, entitled Outsourcing in Drug Development (2nd edition) is available here.