Survey reveals EDC use on the rise for clinical trials across the globe
CB Technologies, a provider of EDC tools and services for clinical trials, has released the results of its recent survey European Life Science Industry: A Report on the Use of Electronic Data Capture (EDC) Technology, which finds growing acceptance and use of EDC technology for clinical trials across the globe. Much like their U.S. and Eastern European counterparts (see eyeforpharma Briefing Issue 27- May 10, 2001 - eyeforpharma.com), participants in the survey cited cost-savings and shorter time-to-market as the major benefits of EDC technology.
Survey results reflect the experiences and viewpoints of 100 respondents representing pharmaceutical companies, biotech firms, clinical research organizations and academic research organizations from 18 countries. Survey data was collected by mail and follow-up interviews were conducted to validate responses.
The majority of participants in the survey run multiple trials each year. More than one-quarter of respondents indicated they conduct in excess of 25 trials per year.
Nearly half (44%) of survey participants indicated they are currently using EDC technology in their clinical trials. Another 6% reported they are not presently using EDC, but have in past trials. The remaining half (50%) of respondents indicated they have not yet implemented an EDC system for clinical trials.
Of those not currently using EDC, 28% indicated they had plans to begin using EDC over the next 18 months. Eight percent (8%)of respondents indicated it would be more than 18 months before they began using EDC, and 20% said they had no current plans to implement EDC.
Of those participants currently using EDC, 19% indicated EDC has been in use at their organizations for more than three years, while 20% reported EDC has been utilized for more than one year but less than three years. Seven percent (7%) indicated their companies have been using EDC for less than one year. It should be noted that 53% of survey participants did not respond this question.
When asked to rate their experience with EDC, the majority of respondents (52%) indicated their companies have had either a positive (29%) or neutral (23%) experience with the technology. Only 7% reported having a negative experience. Forty-one percent (41%) did not respond to the question.
The majority of respondents (70%) believe EDC generates revenue by getting drugs to market faster (26%), saves on the costs associated with clinical trials (16%) or does both (28%). Twenty-two percent (22%) feel it does neither, and 8% did not respond to the question.
User acceptance topped the list of concerns for companies implementing EDC, with 56% of respondents citing it as an issue. Ease of use (44%) and user functionality (44%) were also important considerations to participants. In addition, system performance (43%), security (42%), Internet performance (41%), speed of study set-up (38%), integration with existing systems (36%), cost (36%), availability of vendor support (35%) and regulatory compliance (33%) all were considered important concerns. The responses total more than 100% because participants were asked to choose as many concerns as were applicable to their company.
When asked what types of systems they preferred to use for EDC, 18% indicated a preference for thin client (or Web-based) solutions, 21% for client/server solutions and 34% for a hybrid system. Thirty-seven percent (37%) of respondents indicated they had concerns about using a thin-client EDC solution, 30% had concerns about client/server solutions and 17% had concerns about hybrid systems.
In an open-ended question, participants were asked to identify additional functionalities that would be helpful to them in EDC systems. Although 76% of participants did not respond to this question, those who did respond noted integration with other systems (6%) as a desirable functionality.
When it comes to integrating EDC with other technologies, respondents want to be able to link to sensors (41%) and interactive voice response systems (40%). Thirty-five percent (35%) feel integration with PDAs (personal digital assistants) is important and 32% want to see integration with other wireless systems. Again, multiple responses were allowed for this question.
In an examination of the internal decision-making process at participating companies, respondents were ask to assess what group within their organization has the most impact in selecting an EDC provider. Thirty-five percent (35%) of survey respondents felt their clinical division have the most impact, while 25% cited their biostatistics (13%) and information technology (12%) groups. It should be noted that 22% of respondents felt the decisions are shared across two or more departments within their organizations.
When asked about at what level within their organizations decisions about EDC are made, 33% listed the director level as the decision makers, 15% indicated it is made at the vice president level and 21% reported that it is a company-wide decision.
Many companies participating in the survey (40%) have or will implement the use of an enterprise-wide information portal. Some companies (13%) have already implemented a portal and 27% are considering implementing such a portal.
Survey respondents clearly indicate that EDC is becoming an increasingly important technology as the life sciences industry looks for ways to cut costs and speed time-to-market in an effort to meet the growing pressures of both its customers and stockholders. But in order for the technology to adequately meet the dynamic needs of the industry, survey participants spell out the necessity for increased functionality and flexibility for integration in EDC systems of the future.