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New Mind-Set About eClinical Technologies

By Deborah Borfitz
Exclusive: TUFTS CSDD survey shows positive attitude shift toward technologies.

Dec. 17, 2007 | Over the past few years, there has been a seismic shift in the way biopharmaceutical companies and clinical research organizations think about and use electronic clinical research technology. The changes have been almost entirely positive, according to Ken Getz, senior research fellow at the Tufts Center for the Study of Drug Development (Tufts CSDD) in Boston.

That's the picture painted by a just-released study conducted by Tufts CSDD assessing adoption and attitudes about eClinical technologies and standards. The results are being presented for the first time by Bio-IT World and eCliniqua.

Adoption concerns and barriers today spring more from an "implementation mindset" than worries about management buy-in and lack of a market leader characteristic of a nascent, emerging market, says Getz. "Management cares most about return on investments already made, integration, and internal coordination."

Fears about choosing the wrong vendor have also receded, owing largely to a maturing market with fewer, stronger players accepted as drivers of future innovation. Growing acceptance of data interchange standards promulgated by the Clinical Data Interchange Standards Consortium (CDISC) has raised the "comfort level" in selecting a particular solution. "There's less of a sense of risk now in terms of compatibility," says Getz.

Increased Adoption
For both solutions and standards, familiarity breeds adoption, says Getz. Electronic case report forms, among the earliest clinical research technologies launched, are also the most utilized (by 89% of respondents), closely followed by statistical analysis (82%), solutions for site management (56%), document exchange portals (54%), and electronic patient reported outcomes (47%).

Adoption of CDISC standards likewise mirrors the sequence with which they were introduced. The data submission model, with the earliest produced standards, is used by 69% of surveyed companies, 90% including pilot programs, Getz adds. Standards for the exchange of non-clinical data are all still in the pilot stage. Standards for operational data and lab data are currently being piloted by companies using them, 32% and 26% respectively.

Support for the CDISC mission, overall, is high. More than 70% of respondents were members of the organization, giving input to collaborative efforts to build industry-wide data interchange models.

Companies now recognize many perceived benefits from adopting CDISC standards, due in part to the growing diversity of data interchange models, Getz says. The benefit of improving partner data exchange, named by just one-third of companies three years ago, was cited by 59% in the new survey. Improving data quality early was also cited much more frequently (36% from 11%).

The survey indicates users' growing enthusiasm; experience with the oldest solutions for clinical data informatics and statistical analysis are "very positive," says Getz. Experience with newer solutions for site oriented project planning was rated as positive by 30% of respondents and negative by 20%. "This is also the spottiest area in terms of overall usage. It's done more project to project, so it makes sense that the experience level is more variable as well," says Getz.

Four out of ten companies report having achieved a return on their investment in eClinical technologies, says Getz. The "realized impact" is being felt in more than a dozen different areas, most often in terms of quicker database lock, real-time access to data, and in monitoring program status. Again, the biggest punch is coming from the more "established solutions."

The difficulty in sharing data between various technology solutions remains the chief frustration of companies today, affecting more than two-thirds of respondents. Yet even that is a "positive signal," Getz says, because it implies that fewer companies are still piloting solutions. "They're using them throughout their organization with higher levels of satisfaction and demonstrated benefit."

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