Survey reveals EDC use on the rise for clinical trials
Survey results reflect the experiences and viewpoints of 109 respondents representing pharmaceutical companies, biotech firms, clinical research organizations and academic research organizations from seven countries. Survey data was collected by mail and through phone interviews conducted in the fourth quarter 2000 in conjunction with the University of Sciences in Philadelphia.
The majority of participants in the survey run multiple trials each year. Thirty-seven percent (37%) of the companies surveyed conduct more than 50 clinical trials per year, while an additional 38% report initiating between 10 and 50 trials per year.
More than half (58%) 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. Approximately one-third (36%) of respondents indicated they have not yet implemented an EDC system for clinical trials.
Of those not currently using EDC, 35% indicated they had plans to begin using EDC over the next 18 months. Four percent (4%)of respondents indicated it would be more than 18 months before they began using EDC, and only 6% said they had no current plans to implement EDC.
Of those participants currently using EDC, 31% indicated EDC has been in use at their organizations for more than three years, while 14% reported EDC has been utilized for more than one year but less than three years. Fifteen percent (15%) indicated their companies have been using EDC for less than one year. It should be noted that 40% of survey participants did not respond this question.
When asked to rate their experience with EDC, the majority of respondents (63%) indicated their companies have had either a positive (26%) or neutral (37%) experience with the technology. Only 11% reported having a negative experience. Twenty-seven percent (27%) did not respond to the question.
The majority of respondents (68%) believe EDC generates revenue by getting drugs to market faster (27%), saves on the costs associated with clinical trials (5%) or does both (36%). Twenty-five percent (25%) feel it does neither, and 7% did not respond to the question.
User acceptance topped the list of concerns for companies implementing EDC, with 69% of respondents citing it as an issue. System performance (61%) and integration with existing systems (61%) were also important considerations to participants. In addition, regulatory compliance (57%), ease of use (56%), speed of study set-up (55%), Internet performance (54%), security (53%), user functionality (51%), availability of vendor support (50%) and cost (48%) 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, 29% indicated a preference for thin client (or Web-based) solutions, 18% for client/server solutions and 30% for a hybrid system. Forty-four percent (44%) of respondents indicated they had concerns about using a thin-client EDC solution, 36% had concerns about client/server and 34% 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 57% of participants did not respond to this question, those who did respond noted integration with other systems (5%), an accessible data warehouse (4%), system/data integration (3%), patient diaries (3%) and online training and references (2%) as desirable functionalities.
When it comes to integrating EDC with other technologies, 60% of respondents want to be able to link to interactive voice response systems. Forty-one percent (41%) want to see integration with wireless systems and 40% listed integration with PDAs (personal digital assistants) as important. Again, multiple responses were allowed for this question.
In an examination of the internal decision-making process at participating companies, respondents were asked to assess what group within their organization has the most impact in selecting an EDC provider. Thirty-seven percent (37%) of survey respondents felt their clinical division have the most impact, while 16% cited their information technology department. It should be noted that 21% of respondents felt other groups within their organizations would make decisions of this type.
When asked about at what level within their organizations decisions about EDC are made, 23% listed the director level as the decision makers, 21% indicated it is made at the vice president level and 20% reported that it is a company-wide decision.
Most companies participating in the survey (48%) have or will implement the use of an enterprise-wide information portal. Some companies (12%) have already implemented a portal and 36% 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.