Benefits, Challenges and Technologies

What do you think is the main benefit for the adoption of
decentralized/virtual or hybrid trials?

The first section of this report showed that there is still clearly high hopes for decentralized and hybrid trials in the industry, and this appears to be tied closely to patient-centricity. Indeed, over half of respondents see 'patient convenience and engagement' as the main benefit - far higher than 'shorter timelines' (13%) or 'more diverse patient populations' (11%).

What are the biggest challenges with running decentralized/virtual or hybrid trials?

Other responses:

"Acting on alarm signals appropriately"
"Clearly identifying which parts of each trial process would benefit and provide ROI."

"Public acceptance and trust."
"Amount of detail required by a trained driver to keep all aspects of paperwork and monitoring devices clear and concise are enormous."
"Justifying increase in cost and impact to ROI."

The fact that current usage of decentralized and hybrid trials remains low, shows that there are still significant challenges that need to be overcome. This is reflected by the broad range of responses here, with several challenges all rating highly, particularly around data quality and privacy, technology, and regulatory acceptance.

If you could get one piece of guidance from the regulatory authority around decentralized/virtual
and hybrid trials, what would it be? (Selected responses)

"The possibility and acceptability of non-validated solutions."
"Demands on data collecting technology and eConsent, for them to approve the data for new drug applications."
"Are the agencies in agreement with considering data acquired via DCT as part of a registration trial?"
"Expectations for delegation of authority and technology incorporation/ validation of tools."
"Acceptability of pooled data from varied sources of collection."
"Clearly articulate what is allowable to be conducted outside of the traditional site and how those activities need to be managed under the investigator responsibilities."
"Decision on the data quality standards for using In-Home wearable sensors and downstream predictive analytics."
"Published list of mHealth approved medical devices for taking readings. There is a great deal of confusion on what equipment can be used and what not."
"Acceptance of COA measures when presented on diverse devices/ screen sizes but with carefully validated content."
"Patient Reporting Outcome to be used for patient self assessment."
"Guidance on direct to patient delivery of drug."

"Acceptance of novel measures of health generated from digital devices, sensors, and wearables."
"How to resolve the need for site monitoring of source data versus the need to meet patient privacy laws in Europe. The EU privacy laws are a significant barrier in Europe to conduct remote monitoring."
"Clear guidance on the acceptance of eSignature and telemedicine outside of the US."
"Reassure sponsors what is acceptable. We work closely with regulators and generally find them very open to hybrid trial options but sponsors always assume regulators will not approve."
"Strongly encourage sponsors to include decentralized/virtual and hybrid trials in all phases, starting with pre-IND meetings all the way through."

When deciding on which technology to use for decentralized/virtual or
hybrid trials what is the most important aspect to consider?

Choosing the best technologies for decentralized and hybrid trials is vital to their success. Reliability (49%) is by far the most important aspect in this decision, followed by ease of use (26%). Perhaps surprisingly, cost is a relatively minor consideration, with just 5% of respondents saying it is their important factor.

Which technologies are being used in the decentralized/virtual
or hybrid trials you are working on?

Mobile technologies (53%) are being used most commonly in decentralized and hybrid trials, followed by wearables (41%) and in-home devices (37%).

Respondents in North America top the usage for every technology due to the higher current adoption rates.