EXCLUSIVE

Home visits = regulatory thumbs up? ResearchNurses.co thinks so

30-May-2012 - Last updated on 19-Aug-2020 at 08:43 GMT

The use of home visits in clinical trials could raise the chances of regulatory approval, according to ResearchNurses.co.

In the second part of an exclusive podcast with Outsourcing-Pharma (listen to yesterday’s podcast here) Sue Mackay said that the levels of compliance offered by having a healthcare professional give drugs to patients who would otherwise self-administer is a big plus for the authorities.

“The dosage will be correct,” the research nursing team manager said. “So from a regulatory perspective – I think they would probably quite like that.”

She added that for data collection and monitoring, home visits are a way to boost accuracy.

Mackay also said that the regulators are currently putting an increasing focus on patient retention, something she believes home visits can help with because it is more “flexible” for the patient, and provides them with a personalised point of contact.

“It’s becoming a bigger issue for companies to try to maintain levels of recruitment in studies,” she said.

“I think the regulatory bodies both in the states and here in the UK and Europe and Asia, are looking at is ‘what would make a patient want to be in this study, and stay in this study?’”