The clinical research industry is one of many rules, regulations, processes, systems, privacy requirements and much, much more – for good reason. The safety of the patient, and security of all data and information generated are of the utmost importance. This could potentially be a key reason why this is, or was, an industry that was traditionally behind in adopting new digital approaches. For patients involved in clinical trials, they would usually travel to and from a particular site throughout its duration, often over a period of several years.
Since the outbreak of the COVID-19 pandemic, nearly every organisation around the world has had to evolve and, in many cases, digitally transform to simply remain operable, with clinical trials being no exception.
Many clinical trials were put on hold or cancelled. In research we conducted last year, we discovered:
- Three out of four (74%) life sciences organisations say that COVID-19 has negatively affected their organisation’s ability to deliver on its clinical trial objectives over the next 6 to 12 months.
- 41% of clinical trials in therapeutic areas other than COVID-19 have been delayed or put on hold indefinitely.
However, many sponsors have made the decision to innovate, utilise technology and offer a new patient experience. In fact, 70% of respondents say the pandemic now presents an opportunity for changing the way clinical trials are conducted in the future.
Perhaps a key opportunity for change is the acceptance and use of decentralised clinical trials (DCTs). They have undoubtedly become more popular over the last 12-months, with regulators and clinical trial stakeholders also rapidly accelerating patient access to telemedicine – something mostly thought of as impossible before we couldn’t meet face-to-face.
The moment for digital transformation has clearly arrived.
Firstly, what are decentralised clinical trials (DCTs)?
In essence, DCTs decrease the use of physical locations and instead, increase their reliance and use of technology to make trials more accessible and remote for those patients taking part.
Decentralising a trial doesn’t necessarily mean that the entirety of it has to be remote or virtual and in fact, many in the industry view DCTs as having a choice of ‘2 core modalities’:
- Direct-to-patient or remote: Data is collected in the patient’s home or in an environment that’s convenient for them. This can also be referred to as “site-less”.
- Hybrid: Combines the use of both on-site and remote locations.
Whichever approach is opted for, the underlying purpose is about making trials easier for all parties so that trials can be conducted throughout their phases, patients are able to continue taking part and the associated organisations can generate the data and information for the drug they are trialling.
Why are DCTs only becoming popular now?
Decentralised clinical trials aren’t a new approach.
In 2019 the then FDA Commissioner Scott Gottlieb, asserted his support behind decentralised trials as they enable research to become “more agile and efficient and reduce the cost of developing therapies…to support a range of drug development goals”.
But what part did COVID-19 play? The pandemic has, quite frankly, accelerated the process. It negated the need for patients to travel to trials, simply because they were not allowed to.
In October 2020, the management consultancy McKinsey reported that across industries, COVID-19 has accelerated the adoption of digital strategies by as much as seven years. And in another survey released by Oracle, 76% of more than 250 industry respondents noted that the pandemic sped up their adoption of decentralised clinical trial methods.
Traditional approaches were – and are – no longer sustainable in the current climate of health concerns, differing lockdown rules around the world and variants…to name a few.
Overlaying this foundation of health and welfare concerns is the fact that people’s attitudes have changed. Across the globe, humanity have had to switch to digital with many realising its benefits and growing to trust it – it could be argued that many industries won’t go back to previous operations.
Survive and thrive
Of course, there are pros and cons to whether to opt for a traditional or digital approach (we won’t dive into them here) but it’s likely the future of clinical trials will be a mixture of centralised and decentralised trials depending on what they are seeking to understand and where they are based.
DCTs may just be the winning formula for the future of clinical trials and drug development. In our latest research into the management of the clinical trial data, we found that:
- 75% life sciences organisations plan to invest significantly in technology (e.g. artificial intelligence, machine learning and cloud computing).
- 70% are likely to make a large investment in technology to enable interrogation of clinical data on a large scale.
As the life sciences sector embraces new strategies to improve the way clinical trials are conducted, the priorities for clinical trials are now to:
- Continue the decentralisation of clinical trials – increase remote treatment and monitoring (47%).
- Adopt new technology such as AI, machine learning, and cloud computing to aid the conduct of trials and the management of data (34%).
It’s fair to say that this monumental shift towards a patient-centric approach won’t be going anywhere, or even, slowing down.
In our follow up pieces we’ll delve further into the topic of decentralised clinical trials, as well as discuss their benefits and challenges.
Stay tuned and follow our LinkedIn channel to keep atop of our next articles.
28 Jun, 2021
Arkivum report: TMF Futures 2021, Good data in the age of digital transformation
TMF Futures 2021: Good data in the age of digital transformation This 2021 report is drawn from our second annual TMF Futures survey. Polling the views of…
23 Sep, 2020
Arkivum report: TMF Futures, Keeping Data Alive
Arkivum is delighted to publish a new report into the major trends impacting the long-term management of clinical trial data for life sciences organisations. Forming the core…
27 Apr, 2021
FAIR data principles, what are they and how can they support compliance?
Life Sciences organisations are becoming big data enterprises, generating large amounts of data from clinical studies, lab equipment and drug development. However, this plethora of data is…