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A cultural shift in clinical research

Research organisations across the board are experimenting with new technologies

The clinical research industry is experiencing a fundamental cultural change, with patient- centricity becoming the primary area of focus.

New technologies are driving the speed and scale at which this shift is being realised, spurred on further by the unprecedented challenges thrown up by the COVID-19 pandemic, disrupting business as usual and promoting greater efficiency.

Patient-centricity in clinical research design has been an ideal many have strived for over the past decade, but this has only recently become a reality on the ground. Now new technologies are driving a cultural shift in clinical research, putting the patient experience at the heart of the process.

The impact of the COVID-19 pandemic

For the scientific community, 2020 was a pivotal year. But while unprecedented feats were achieved in clinical research for COVID-19 treatments and vaccines, many other projects were halted and patient recruitment stopped entirely.

In fact, a survey showed that more than 75% of pharma and biotech companies faced significant disruption in their clinical trials last year. These delays are likely to impact the sector for years to come, slowing down the pipeline of new medicines and therapies.

By contrast, the discovery and development of multiple successful vaccines and treatments for the novel coronavirus were only made possible by flexibility and ingenuity in the clinical research process and the goodwill of trial participants.

The research sector has adopted new approaches at rapid speed in order to cope with the challenges presented by COVID-19. Many of which transitioned to virtual approaches overnight to interact with trial patients, made possible by a range of innovative technologies.

Moving forwards, it’s important the lessons learned during the pandemic are remembered and adaptations are made to protect the research process against future emergencies.

What’s clear is that COVID-19 will permanently accelerate the use of remote technologies in clinical trials, reducing the need for in-person visits, to drive efficiency and uphold the highest levels of patient safety.

The rise of remote monitoring

In a post-pandemic scenario, we expect to see a mass adoption of virtual introductions and check-ups, which will minimise the need for patients to travel to investigative sites, as well as increased device integrations with consumer and medical data capture tools.

This, in turn, will simplify patients’ participation in clinical trials and improve their overall engagement, helping to drive medical advancement forward.

Perhaps the simplest step in moving towards a more patient- centric trial is the routine use of eConsent and telemedicine methods.

Since 2018, the MHRA has allowed the use of electronic methods for seeking, confirming and documenting informed consent for participation in research. It enables potential research participants to be provided with the information they need to make a decision via a tablet, smartphone or digital multimedia.

This digitalisation is credited with improving understanding, providing feedback on how consent materials can be improved, reducing dropout rates and enabling process efficiencies.

Similarly, telemedicine is now frequently used for routine patient monitoring and follow-ups, particularly in phase 1 studies. This method can also be used to measure select objective outcome measures, but the data collected is unlikely to receive regulatory approval. Until that point is reached, we’re unlikely to see a full switch from in- person monitoring to virtual.

Intelligent devices and packaging

Another important area of development is intelligent devices and packaging, creating secure two-way communication pathways between patients and clinicians during trials, while also helping to decentralise these trials. Perennial encryption technology is used to protect the sensitive data being collected and shared with trial leaders.

Wearable devices worn by patients during trials is one component of this new approach, allowing clinicians to track and analyse health information such as heart rate and pulse, temperature, blood oxygen levels, stress levels, breathing rate, and even different types of brain activity in real time.

Essentially, these devices (usually worn on the wrist) acts as personal assistants, monitoring patients’ health status and alerting them about abnormal conditions, medication reminders and medication tracking.

A second component is the integration of intelligent technology into existing medical packaging (such as blister packs) or devices. This is chipped with a wireless electronic component that allows tracking of drug usage as soon as the tablet is ejected from the blister or the device is used.

In most cases, contact materials are not affected and the digital enablement, along with options for child resistance, are added as additional layers requiring no regulatory approval.

Each time a tablet is removed, or a medical device is used or activated, a signal is sent from the packaging or device to the wrist monitor. The wrist monitor will then send the information to the clinical trial administrator team, either directly or via a smartphone to the cloud and then to the host. This transmission of data can be programmed to occur in real time or as a scheduled event.

Research organisations across the board are experimenting with new technologies such as these to streamline clinical research design and improve the patient experience.

However, it won’t be until regulators catch up with these advancements and offer clear guidance on how they will interpret the data and insights gained during the approval process that we truly start to leverage the power of these remote technologies.

Rich Quelch is Global Head of Marketing at Origin, www.originltd.com

2nd March 2021

Rich Quelch is Global Head of Marketing at Origin, www.originltd.com

2nd March 2021

From: Research

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