The way that clinical trials are conducted is changing.
As a result of the pandemic, decentralised clinical trials are increasing, and what was previously a necessity is now being considered beneficial for both clinicians and patients as digitisation continues to impact life sciences.
As Deloitte describes, digital transformation is no longer a buzzword – it’s a strategic imperative.
At a time when only 20% of biopharma companies are digitally maturing, how is digitisation changing clinical trials in life sciences?
In post-Covid-19 healthcare, there is an increasing reliance on virtual tools and technologies to make clinical trials more convenient and accessible.
Nearly all of the major elements of clinical trial planning can be done digitally, which would be considered a decentralised trial.
This means that elements of clinical trials such as patient consent, assessment, and data collection can be done virtually, whether through online patient-reported surveys or video assessments.
According to McKinsey, roughly 70% of potential clinical trial participants live more than two hours from trial sites, meaning that decentralised trials offer the opportunity to reach a larger (and potentially more diverse) pool of patients.
Digitisation is increasing accessibility through the use of technologies/services such as:
Electronic clinical-outcome assessments (eCOAs)
Remote patient monitoring
Three Nordic companies – AlzeCure Pharma, a Swedish pharmaceutical research and development company; LINK Medical, a Norwegian contract research organisation; and Viedoc, a Swedish provider of decentralised software solutions for clinical trials – are analysing the effect of decentralised solutions.
This ongoing pilot study relates to a novel treatment for neuropathic pain.
Part of the inspiration behind the pilot study was the shift that occurred during the pandemic to remote visits, which worked effectively and had positive responses from patients who didn’t have to travel for studies.
During the enrolment phase of this study, web-based questionnaires and phone or video interviews were implemented, limiting the number of patients going to the clinic and effectively filtering out those who didn’t meet the criteria.
Viedoc also provided an eConsent process, which includes a video explanation of the study details and an informed consent form.
Though onsite visits are a required part of the ongoing trial, patients can still receive questionnaires to fill in from home, with the data then being fed into the study database and made visible to clinicians, data monitors, and site staff.
A huge benefit of this shift has been that clarifying anything for patients is far easier.
Whilst previously, any misunderstandings around a paper questionnaire would take time to discover, online questionnaires make the identification (and solving) of potential issues much more seamless.
This isn’t to say that digitisation has completely removed the need for face-to-face clinical trials – a combination of decentralised and onsite steps was still viewed as the ideal balance for a clinical trial.
As with many areas of digital/technological advancement, the most important element is balance.
It is likely that as more clinical trials and studies implement digital/decentralised solutions, the benefits will encourage further uptake.
As the process of digitisation advances, so too will the methods used to advance it, such as analytic procedures that can be done at home (e.g. patients taking home finger prick tests for dried blood sample testing).
McKinsey anticipates a significant increase in the uptake of decentralisation elements due to experience gained during the Covid-19 pandemic.
Additionally, people’s comfort with health technology has increased considerably because of the uptake of digital health technology - such as fitness wearables - and this will only increase more over time.
Patient enrollment and retention are huge elements in the success of clinical trials.
If patients aren’t recruited and retained properly, a knock-on effect could occur on study costs due to the need to extend the trial period as a result, alongside further delays.
Geographical distance to the study site is also a huge barrier to recruitment and retention – digitisation offers the opportunity to implement decentralised clinical studies so that geographical distance is no longer an obstacle to recruitment and retention.
Leveraging remote technologies for clinical trials, such as mobile apps, telemedicine and biomedical devices, reduces these geographical and financial barriers at a time when many patients will be prioritising their comfort.
Clinical trials are, by nature, data-driven.
Digitisation provides a breadth of data from the use of apps, wearables and other technology.
This data can facilitate timely interventions, meaning that if patient sentiment changes during the process of the trial, data will be captured in real-time, improving their satisfaction.
Another benefit of the data that digitisation will provide is a more patient-focused trial, putting collaboration at the heart of the process.
To be able to best deliver actionable results and keep patient satisfaction high, efficient data capturing is a must, which is exactly what a more digitally advanced clinical trial does.
Digitisation is permeating life sciences on a wide scale, and it isn’t just clinical trials that you can expect to see these changes occurring.
Even areas such as the clinical supply chain could be considerably impacted by digitisation, with smart supply strategies such as drug-pooling and just-in-time packaging being implemented as part of a more integrated supply chain management solution.
Cell and gene therapy is another area that requires the acceleration of digital solutions to grow in both a research and commercial capacity across the entire value chain.
Given the complexity of cell and gene therapy trials, technological advancements are a critical component to be able to make the availability of personalised medicine more widespread.
In other words, digitisation isn’t on the horizon, it’s already here - and it has the potential to change the way that clinical trials are conducted for the better.
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