A Canadian research group that develops, conducts and analyzes trials of cancer therapy is about to deploy a Web-based system to capture data in the field and reduce errors.
The National Cancer Institute of Canada’s Clinical Trials Group (NCIC-CTG) has selected Rave, a remote data capture product developed by New York-based Medidata, for use in 30 Phase I-III trials over five years in Canada, the U.S. and Europe.
The product will be rolled out in phases, beginning with one clinical trial later this year. The NCIC-CTG is based out of Queen’s University in Kingston, Ont., but almost all clinical trials involve patients outside of Canada.
NCIC-CTG director Dr. Joseph Pater said the notion that clinical trials could be assisted by remote data capture has been around for some time, but advancements in broadband and an acceptance of Web-based tools are accelerating adoption. The decision to use Rave came out of recommendations from the Ontario Institute for Cancer Research, and Pater said Medidata’s work with the U.K. Cancer Research Network showed it had a good track record.
Clinical trial data, which can include a lab report or an X-ray, is usually entered by hand by data-entry staff once principal investigators and their teams return from the field. These paper-based reports are prone to mistakes, Pater said.
“They might just mess up a date or misspell a word,” he said. “We send them a letter back and they have to fix it. Fixing it means going back and finding that chart.”
The Rave system will use online forms to allow nurses or those with medical records training to enter data as it comes in, and will include automated checks to identify errors earlier on, Pater said.
“The more you can do in terms of cleaning that data, the easier things become for that nurse or that doctor who’s working through the trial,” said Medidata CTO Glen de Vries. “We can capture things like mistypes of blood pressure as 20 over 80 instead of 120 over 80. We can immediately get that person to correct it. They’re getting immediate feedback, so they never have to revisit (the form).”
De Vries said it’s important to use clinicians and data managers who understand the nature of the trials being conducted to help set up the right kind of Web-based interface for the remote data capture.
“It’s (a case of) configuration, not customization,” he said. “You eliminate a lot of the pain and a lot of time and a lot of the cost of having to go through a process that looks like software development.” Although Rave will mean data is captured faster, Pater said time is less of an issue in clinical trials that are conducted over a period of years.
More significant is the growing number of organizations in Europe and the U.S. that have adopted these Web-based systems. Canada is somewhat behind in this trend, said de Vries, and given that the NCIC-CTG works in collaboration with international counterparts, it is important to start making the transition. While many vendors simply sell a software licence and host services from their head office, Pater said Medidata will train NCIC-CTG to set up clinical trials on Rave itself.