Under a crush of data and protocols, very few trials are completed on schedule. In fact, only 6% of clinical trials are completed on time, with the overwhelming majority (72%) running over schedule by at least a month, according to the Center for Information & Study on Clinical Research Participation. Trial designs, increased patient enrollment and extended treatment periods also contribute to time delays, according to researchers in the life sciences industry.
Investigator sites worldwide are struggling to stay on track amid an ever-increasing number of clinical trials, each with unique, complex protocol design. Certain therapeutic areas, such as oncology, have been especially susceptible to longer study durations. From 2002 to 2014, for example, the median duration timeline of a typical oncology clinical trial increased by 69%, from 23 months to 39 months, adding an additional 16 months on average to complete studies, according to the August 2015 edition of Applied Clinical Trials, an industry journal.
Meanwhile, burgeoning study metrics generate an enormous amount of data that must be collected, managed and directed in the site environment. This requires site staff to be proficient administrators in data management and familiar with all technologies involved in the trial program. Investigator sites must understand the unique requirements for each trial, including the equipment, technology and procedures used.
“The hands-on role and experiences of site staff in data management are important factors for sponsors to consider when evaluating and purchasing electronic data capture (EDC) technology,” said Kuno van der Post, Ph.D., senior vice president of business development at OmniComm Systems, (OTCQX: OMCM), a global leading provider of clinical data management technology. “During clinical trials, EDC technology can increase efficiency, cut costs and reduce the risk of errors”.
“Too often, EDC purchase decisions are made from the perspective of those who set up the systems, while overlooking the viewpoint of those who actually use the system,” Dr. van der Post said.
Site researchers favor EDC systems that deliver ease of use, performance and support. TrialMaster® — an EDC system from OmniComm Systems, Inc. — received the highest satisfaction ratings for ease of use, performance and support when compared to more than 10 other leading EDC systems, according to a recent independent study.
“We are delighted to have the site survey confirm what we have been hearing anecdotally for years — namely, that the site investigators really prefer our EDC system. We were actually surprised to see that almost 3-out-of-5 sites preferred TrialMaster EDC over the presumptive market leader,” Dr. van der Post said. “Notably, our customer service and support are recognized as far superior to our larger competitors, based on the survey results. Again, this is great validation of our position in the current market as the EDC specialist.”
Independent Survey Results
Porter Research, an independent firm based in Atlanta, conducted an anonymous survey of clinical research site investigators and staff from more than 200 countries to measure degree of satisfaction and preference of EDC systems. The results were tabulated from 850 respondents.
Survey participants were asked to select their preferred EDC brand, pertaining to their experience, and then rate different areas of satisfaction based on: ease of use, performance and support.
OmniComm’s TrialMaster EDC was the only EDC system that exceeded the average in each category.
Respondents used, on average, 3.5 EDC systems during the past two years, with some researchers using as many as 11 EDC systems.
Survey respondents selected the following as important criteria in an EDC system: 1) ease of data entry, 2) simple login and navigation, 3) overall user-system familiarity, 4) user-friendliness and 5) easy-to-answer queries.
This is the second in a series of blogs posts related to the anonymous Porter Research survey.
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