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4
Jun
The New Virtual Trial
by CEO, Graham Wylie

The New Virtual Trial

There has been a resurgence of interest in the virtual trial concept over the last year or so in the ‘innovation’ sphere of clinical research – that undefined part of the trials sector that develops and tests new ideas on how to run trials better.  It is born out of the developing push for ‘Patient Centric’ concepts in trials and the development of new digital technology tools.

 What do you need to know about the New Virtual Trial concept?

 It is part of the developing push to create trials that are more patient centric.

 It uses a variety of technologies that allow patients to be seen in the community – at home – rather than visit the sites.

 These technologies exist in basically three categories, from the perspective of non-technologists:

1.  Apps that the patients have on a mobile device that allow them to record data about themselves – ePRO in effect.

2.  Apps plus devices that record data about the patient automatically – anything form consumer wearables such as a fit bit to specialised devices capturing biometric information, that might or might not be wearable - such as a 24-hour ECG halter or a weighing machine.

3.  Telemedicine tools that allow interactions with healthcare professionals, for example, video calls with physicians.

 

What are its strengths?

 These tools allow patients to be seen in the community, reducing the need for as many site visits in trials.  Like our own service – Home Trial Support – this has a tremendous impact on the work load the trial puts on the patient.  It therefore shares the same value proposition as HTS – reducing workload leads to improved recruitment and retention and therefore faster trials.

 

What are its weaknesses?

 Like its predecessor virtual trial experiments, the new virtual trials lack some essential elements of patient care.  The technology still cannot replace a full face-to-face human interaction between a patient and a HCP.  As such it is inherently limited to very safe clinical trials with well understood IMP that ensures it will remain very niche until mainstream medicine adopts more digital patient interactions to replace face-to-face care.

 

The future

 To maximise the value of the technology right now, we need to target not virtual trial designs but hybrid designs that include technology for virtual visits, site visits as we are used to and HTS visits where the nurse visits the patient in their home.  Together these allow trial design to incorporate all the useful tools such as the various technologies and HTS, therefore benefiting from significant reductions in workload for the patient, whilst minimising the loss of face-to-face interactions, as HTS nurses see the patients regularly and perform the trial tasks in the community that technology cannot do (take a blood sample, give IMP infusions, etc.) but which don’t need a visit to the site, and the PI and their team see the patient regularly to ensure the overall progress of the patient medically is properly overseen by a physician.

 

The impact of hybrid design

 HTS has now been operating for almost 12 years in our hands and is a well understood method to run trials in the community, but typically we run perhaps 50% of visits in a trial at home, the other 50% running at the site.  Virtual visits will increase the percentage of visits that will take place in the community to perhaps 80% routinely.  Some of these will be ePRO style (just an app) visits, some will be app plus device and some will be telemedical, depending on the need.  Nurses can use the same or different apps – it makes little difference as the data combined in the patient data management system in the end anyway.  Site visits will be rarer, perhaps just at the start and finish of therapy or perhaps at a regular frequency defined to manage disease progression and IMP safety.  Patients workload will diminish and not only will patients close to the hospital be recruited in the trial, so will those a long way away.  This last group is where patient concierge services will fit in, so that when the infrequent visits to the site are required it will be ‘hassle free’ for the patient.  The bottom line will be a more patient centric trial design and a faster trial.

Posted by:
Laura Lange
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