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.
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.
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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