Anatara Lifesciences has hired “virtual” research organization ObvioHealth Partners for what the firms claim is a first of its kind hybrid clinical trial.
The study – which is examining a regimen called gastrointestinal re-programming for the treatment of patient with irritable bowel syndrome – diarrhoea subtype (IBS-D) – will use both patient self-reporting and in home assessments.
Participants will use a smartphone app developed by ObvioHealth to submit information on quality of life and health changes. This data will be monitoring in real-time to detect possible adverse events and issues with protocol adherence the firms said.
The trial is taking place in Australia, which is a major reason the Anatara and ObvioHealth opted for a decentralized approach according to the latter’s CEO Ivan Jarry.
“Of the more than 40 virtual and hybrid studies we've conducted around the world, this is our first in Australia… In a country with such vast rural areas, we're pleased to be able to offer clinical trial opportunities wherever patients live."
Microbiome
Antara CEO Steve Lydeamore was positive about both the study and the potential benefits of the treatment regimen.
"Irritable Bowel Syndrome (IBS) impacts around one in five Australians at some point in their life with no current definitive cure… It is anticipated that GaRP's mechanism of action will relieve symptoms of IBS-D by reducing inflammation and assisting repair of the gut lining, positively influencing the homeostasis and metabolites of the microbiome.
“We are pleased to be collaborating with ObvioHealth in undertaking this clinical trial to demonstrate these anticipated benefits following extensive pre-clinical work on the GaRP program."
Decentralized trials
The study is ObvioHealth’s first in Australia, however, the firm already has links with the country. In July, the firm attracted investment from Sydney-headquartered CRO Novotech Health Holdings in a deal focused on virtual trials.
Under the agreement ObvioHealth became Novotech’s preferred provider for virtual clinical trials in APAC with Novotech becoming preferred CRO in the region.
And local demand for such studies is increasing according to Jarry, who told EurekaAlert earlier this month that “Asia-Pacific is an area of opportunity for ObvioHealth– not only is it the fastest growing region for clinical trials, but we’re also seeing a growing interest in DCTs, especially from patients in APAC who are increasingly accepting and adopting digital health tools.
“Our partnership with Novotech provides us with the local expertise often required when conducting studies in APAC where regulatory agencies, language and cultural customs vary by country.”
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