Dr Rashmi Narayana
Chief Scientific Officer, Aparito
With the transition to hybrid and decentralised clinical trials, the need to ensure they continue to meet stringent regulatory requirements remains paramount.
Yet the shift away from the traditional trial format offers a number of benefits, such as increasing diversity in participating patient groups.
Dr Rashmi Narayana suggests the digital elements of decentralised trials enables hard-to-reach patients who may not have previously participated, because of physical location, for example, the opportunity to be included in studies.
This has also increased the reach from developed western populations to those in more remote areas in low-and-middle-income countries via better internet access. “This diversity of the people who enter trials improves outcomes for all,” she adds.
There are also economic benefits for patients and accompanying family members in participating digitally in terms of reduced travel or accommodation costs, as well as lifestyle factors.
“So many things in life are moving to digital, whether it is paying bills or day-to-day transactions,” she continues, “so to have a digital experience in a clinical trial via a smartphone should become a lifestyle choice.”
An important component of this change lies in ensuring regulatory compliance from accreditation and data management to legal factors.
Dr Narayana says if trial data does not meet guidelines and standards, such as ISO 27001 covering information security management systems, or ISO 13485 for medical device software, the product and data will not be considered by pharma and biotech sectors.
Dr Narayana is Chief Scientific Officer with global health-tech company Aparito. Their flagship Atom 5™ platform is an end-to-end platform for conducting hybrid and decentralised clinical trials.
She says: “We have regular audits to ensure we meet all quality, compliance and regulatory requirements while maintaining highest standards of data security is central to everything we do.”
This diversity of the people who enter trials improves outcomes for all.
The platform provides support for its clients in patient recruitment – often in a rare disease context – and with consent, enrolment, patient experience and visibility of where patients are in the clinical trial journey, data capture, and monitoring and compliance, to decommissioning a study.
“We also have telemedicine features on our platform for remote consultation that can be done securely, adhering to necessary regulatory guidelines,” adds Dr Narayana.
The company’s in-house data scientists have devised an algorithm for a video capture functionality that blurs facial features to comply with patient confidentiality and privacy. It also has options for enhanced consent where facial features are required for diagnosis.
The digital endpoint is an extra dimension with hybrid and decentralised clinical trials within the platform.
Dr Narayana explains: “Digital endpoints are a relatively nascent area in the clinical trials space but gaining traction.
“The most traction we are seeing is in digital endpoints in Parkinson’s disease, cardiology and in rare diseases such as Duchenne muscular dystrophy, mainly looking at upper limb and lower limb movements especially from the transition from ambulatory to non-ambulatory stages of the disease.
“With our technology, there is a digital endpoint that will help clinicians, carers and academics, as well as help parents prepare better if a child is likely to go from the ambulatory to non-ambulatory phase.”
As regulation develops in this sphere, Aparito monitors European Medicines Agency and US Food and Drug Administration regulations to maintain high adherence and patient safety.
While it has its own rigorous processes, it also recognises that clients have similar stringent processes, such as electronic consent and e-signatures, that it needs to harmonise with.
That embraces adherence to FDA 21 CFR Part 11 on how to handle data regarding electronic records and signatures and GxP in good clinical and laboratory practice.
“With every data point collected on Atom 5™ our clients in biotech, pharma and academics can be confident that data provenance is assured,” she says.