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Australia: ResApp plans new cough trial

Shares in ResApp Health jumped more than 28% earlier this week after the investigators of the group’s clinical trial confirmed that their study was not an accurate or reliable evaluation of ResApp’s algorithms. The release of the initial trials caused shares in the Perth-based digital healthcare operator that focuses on respiratory diseases to crash 77% after they showed significant problems with its main product.

“Having completed a review with all relevant parties it is clear that the first US study was not a reliable evaluation of ResApp’s algorithms and that the top line results do not reflect the actual performance of ResApp’s technology,” said ResApp CEO and managing director Tony Keating.

ResApp’s main product is a cough-based diagnostic test that works with a smartphone to analyse the sound of a patient’s cough and to diagnose any underlying conditions.

In that trial, two main problems were found. First, that contrary to instructions and training, a high number of patients were treated before clinical research staff recorded their cough sounds. And second, a high number of recordings were found to contain a second person’s cough sounds or an unacceptable amount of background noise and interference.

ResApp  plans to restart the study  this winter in the US.

To improve the data gathering element of the study, ResApp will be present onsite conducting clinical study team training, reviewing enrolment procedures and verifying data to help ensure that high-quality cough sounds are collected as early as possible during the patient’s hospital visit and prior to any treatment known to affect cough analysis. Every cough sound collected will be quality checked within days of its recording to ensure that all of the data used to subsequently analyse the performance of the algorithm is uncorrupted and high fidelity. An improved audio recording smartphone application incorporating built-in checklists, automated background noise estimation and additional visual aids will be deployed further to support the data collection teams and eliminate inappropriate collection of cough data with background noise contamination.

ResApp’s algorithms have also been modified to reduce the impact of the low frequency electronic interference found in nearly 15% of the previous study recordings.

ResApp plans to broaden its paediatric clinical strategy by reconfiguring its Australian study to support European and Australian regulatory filings directly. Since earlier this year, the Australian paediatric study at Joondalup Hospital has been recruiting patients for double-blind prospective analysis with 230 patients recruited to date. To support regulatory submissions, a team of clinicians will perform adjudication and Curtin University health researchers will provide independent statistical analysis.

ResApp shares closed on Monday at A$0.09 (US$0.07).

Posted on: 06/09/2017 UTC+08:00


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