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The era of the digital clinical trial may already be upon us
thanks to the impacts of COVID-19. While conceptualisations
of the ‘digital patient’ and technology-integrated clinical
trials were somewhat futuristic even in 2019, with COVID-19
grinding clinical trials to a halt in 2020, the life sciences
industry may be forced to pivot into this conceptualised digital
era much faster than anticipated – and, unlike most
COVID-related impacts, this isn’t bad news. While this
presents an exciting opportunity for life sciences and bio
technology stakeholders to digitally innovate the clinical trial
process, steps toward digital innovation should be matched with
increased attention to regulatory caveats, patient privacy and data
protection.
COVID-19 and the requirement to think differently
and digitally
COVID-19 has impacted clinical trials globally. Border
restrictions are preventing patient access to trial sites, there is
increased concern from patients about exposure to COVID-19, trial
drug supply chains are being interrupted and medical resources and
personnel involved in clinical trials are being reallocated to the
pandemic’s front line. In response, international and
domestic regulatory bodies are publishing guidance on alternative
models and approaches for conducting clinical trials. This
guidance has largely included
using technology to overcome COVID-induced
obstacles.
For example, in the United States, the Food and Drug
Administration (FDA) is encouraging sponsors,
clinical investigators and Institution Review Boards to consider
adopting altered policies and procedures regarding informed
consents, study visits and procedures, data collection, study
monitoring and adverse event reporting in clinical trials.
Australia’s stance
In Australia, the Australian National Health and Medical
Research Council (NHMRC) has released
the COVID-19: Guidance on clinical trials for
institutions, HRECs, researchers and sponsors
(Guidance). The Guidance outlines that
employing digital strategies to continue clinical trials during
COVID-19 is acceptable, and now encouraged, where
certain approvals are obtained.
Practically this looks like using strategies to gain
pre-approval for certain categories of amendments to clinical
trials, including:
- allowing virtual visits by patients;
- employing telehealth – providing telemedicine and medical
education via digital means; - using electronic consents for trial participation;
- using other means to implement teletrials;
- changing the trial ‘site’ to a location outside of a
hospital or clinic (and using digital platforms to transmit results
and research); and - broadly, any other changes that do not implicate
participants’ safety or well-being and are intended for the
purpose of safeguarding the health of participants, researchers and
staff or the community via infection control or the burden of
participation in a trial for the participant or researchers.
The last broad suggestion by the NHMRC in particular opens the
door for technology and life sciences industries to collaborate and
create innovative ways to use technologies in clinical trials, as
long as they safeguard health, protect against infection and reduce
the burden of participation in clinical trials during COVID-19.
While using digital technologies in Australian clinical trials
must be seemingly COVID-related for now, we consider this digital
shift may well be the catalyst for the era of a digital clinical
trial in a post-COVID world.
What this means – digitalisation in clinical trials
Technology has already revolutionised many industries. In
the travel, banking and retail industries, digitisation has changed
the ways we hail transport, conduct banking transactions and shop.
Similarly, in the life sciences space, digital intervention
in clinical trials could mean:
- de-centralised research and testing resulting in access to
broader demographics using remote trial locations; - improved patient experiences and therefore increased patient
trial participation and retention; - more accurate and real-time data collection; and
- expedited trials.
Faster trials may mean faster concept-to-market timeframes for
in-demand medicines and treatments.
Moreover, the acceptance of teletrials, digital apps for
patient-to-trial matching, e-consents and the use of wearables and
smart devices for data collection and sharing into clinical trials
could open the door for biotech’s to plug large (and arguably
‘Analog Age’) deficiencies in existing clinical trial
processes.
Privacy and data protection
As demand for digital solutions increases in 2020 and beyond,
those involved in manufacturing, supplying or implementing medical
technologies need to be keenly aware of, and implement, privacy and
data protection processes and strategies.
By nature, data collection and exchange in clinical trials
involves sensitive patient information. Securing protection
of this data is crucial to building patient trust and creating a
sustainable digital infrastructure.
Final thoughts
COVID-19 is forcing regulatory bodies and medical research
stakeholders to think laterally to overcome pandemic-induced
obstacles to clinical trial progress. While we may not see a
digital overhaul in clinical trials immediately, we do consider
that COVID-19 and the need to pivot will see a digital shift in the
life sciences industry permanently.
With this, we expect greater collaboration between the
technology and life sciences industries. In order to be
successful, however, we consider parties hoping to capitalise on
this digital opportunity in clinical trials will need astute
understanding and implementation of privacy and data
protection.
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