Automated drug accountability systems are becoming “the norm” in clinical trials because they can improve compliance and cut working time drastically, according to Cenduit.
The firm recently rolled out its Interactive Response Technology (IRT) which replaces traditional paper records with an online system to monitor the drugs patients are given, and the dosages that are returned.
According to global head of sales and marketing Tony Frankland, the firm’s new system – as well as a range of other new online programs emerging on the market – are being embraced not only because they centralise the process, but because it means ongoing monitoring of the information.
“If you can imagine a typical situation, there are around 1,000 patients per trial site – of which there could be several – each treated for two years with packs of medicines lasting around three months. It’s a lot of paperwork,” he told Outsourcing-Pharma.com.
“Quite often [collating this information] is left until the end of the process because at the beginning and during people just want to get the ball rolling,” he said, adding that having a centralised database in place sooner means trial workers can monitor how well their patients are following protocol during the course, hence boosting compliance.
“Having a ready-to-go database could provide accurate view as to how well your patient is complying, and you will know if you have a problem faster,” he said.
He said a consistently updated, centralised database of drug accountability could also help earn regulatory brownie points for sponsors and contract research organisations (CROs) because they could easily present a summary of the information if asked.
Not for everyone
Frankland said Cenduit’s system can be used on both new trials and those already running.
However he admitted it is unlikely a trial which already has extensive paper records would switch to the new system, and so the biggest target clients are those just starting.
“What you shouldn’t do is run both paper and internet systems,” he added. “If you do that you have two sets of data and you would have to choose which set of data to use, and it’s just wholly counterproductive.”
He also said that though online databases of drug accountability will become commonplace for trials in which patients must self-administer meds, it won’t necessarily take-off for long-term studies.
“I’m not sure how much difference this would make to trials such as long-term oncology, where the patient is only being treated once a month in a hospital setting. The patient drug accountability is already done in this case,” he said.