Site researchers report dramatic spikes in the number of procedures and the complexity of tasks related to clinical protocols over the last 10 years, according to an independent study. Why? Clinical protocols that guide the research team’s activities have increased in complexity, generating more data than ever before.
Complications have resulted as sponsors and Contract Research Organizations (CROs) set additional requirements that research teams must accommodate into their daily trial workflow.
Against that backdrop, site researchers favor electronic data capture (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 an independent study.
“Electronic data capture is very important to clinical trials; it is one of the few technologies that touch 100% of the trial. People forget that EDC deployment is only successful if physicians, nurses and other clinical researchers interact with the system appropriately, and most importantly, in a timely fashion. We enable them to easily and accurately input data with minimal pain the first time, whether those pains be the learning of a new system or navigating through a complex work flow,” 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.
“Transactional errors are detected at the point of data entry, and therefore, can be picked up and quickly resolved on TrialMaster. That means medical professionals can spend less time inputting data and spend more time doing their real job: caring for patients and families, or handling medical emergencies.”
Dramatic Spike in Clinical Protocols
The growing burden placed by CROs and sponsors on clinical site investigators and site staff include escalating development time, difficulties in patient recruitment, regulatory expectations and significant operational hurdles. Additionally, site investigators are challenged with clinical trial remuneration, technology tools, protocol complexity and sponsor demands.
The following chart — from the May 2014 issue of International Journal of Environmental Research and Public Health — illustrates the 10-year (2002-2012) overall growth in total procedures and work burden per protocol by phase.
The demands on trial resources often result in delays, extending the duration of the study and increasing stress on all program participants. The escalating development time for trials has consequently lengthened patient involvement time, which makes trial recruitment considerably more difficult for researchers.
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.
“The results from this survey of clinical investigator sites reflects the feedback we have received from our support and customer-service teams, and confirm that we are on the right path with our product and operations strategy,” said Stephen Johnson, COO of OmniComm Systems. “After all, our goal is to provide the best EDC technology and superior service to our community of clients and site user
This is the first in a series of blogs posts related to the anonymous Porter Research survey.