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2021: the year of decentralisation in drug development

By Marie McCarthy

Decentralisation across the healthcare industry gained traction in 2020.

Rising costs and timelines to bring innovative therapies to market – not to mention the COVID-19 pandemic – have accelerated the surge in demand for decentralised clinical trials. As
we move into 2021, the industry will witness the year of decentralisation, with the growing implementation of digital health technologies, in-home clinical services and remote monitoring across drug development programmes.

In fact, a recent survey released by Oracle showed that 76% of more than 250 industry respondents noted that the pandemic sped up their adoption of decentralised clinical trial methods.

These trials leverage technology to treat study patients remotely. However, despite the trend toward decentralisation over the past few years, sponsors have struggled to operationalise and execute this patient-centric approach effectively. Some of the industry’s reluctance stems from perceived high costs, unknowns around patient safety and reliability of remote data collection.

Hybrid models offer a viable alternative. In contrast to rigid traditional trial designs, where most procedures are conducted on site, hybrid trials combine traditional and decentralised elements, where some tests can be performed remotely and others in person at a study site.

Consequently, these trials offer a more agile framework, affording more choices and flexibility to sponsors, sites and patients. Whether decentralised or hybrid, amid pandemic stay-at-home mandates, their benefits become readily apparent to keep patients safe from viral infection and enrolled in studies by providing home healthcare options and direct-to-patient shipment of investigational products – in addition to keeping trials moving forward through remote clinical site monitoring.

Beyond solving challenges related to the recent pandemic, decentralised and hybrid trials can significantly reduce time spent documenting outcomes and collecting data. As we move forward through the next decade, we will see decentralised elements as an expectation, if not a requirement, of all protocols.

The future patient and clinical trial participant will also expect personal options for clinical trial engagement. Here we discuss the opportunities that decentralised and hybrid trial models bring to patients and the broader healthcare industry.

Improve patient-centricity, trial quality and outcomes with digital health

COVID-19 highlighted the lack of diversity in clinical research, as certain segments of the population, such as older adults, pregnant women, children, and racial and ethnic minorities are affected by the virus in different ways.

As a result, recently published FDA guidance provides recommendations for improving clinical trial diversity, including decentralised strategies such as reducing site visit frequency, when appropriate, in addition to encouraging the use of telemedicine and other digital health technologies. Historically, access to clinical trials, and subsequently low enrolment, has been one of the greatest hindrances to clinical trial efficiency.

Leveraging a decentralised or hybrid model brings the trial to the patient by removing the burdens of travel and distance to make trials feasible across demographics. As a result, trials will reduce racial and socioeconomic disparities in healthcare and improve overall outcomes.

In fact, one study found a three times greater rate of recruitment observed in the decentralised arm compared to the conventional arm. Moreover, the study reported that patients in the decentralised model had better representation from urban and rural areas.

Further, trials using decentralised elements capture real-world data from patients’ everyday lives, dramatically improving the quality of data collected on the impact of therapies in a population.

Digital health technologies used in hybrid or decentralised trials may include eConsent, telemedicine, wearables, electronic clinical outcome assessments and EHRs. Mobile devices can also be used as electronic diaries and to collect data from sensors in real time.

What’s more, emerging innovations such as AI and machine learning coupled with cloud-based platforms are enabling real-world evidence. As a result, these technologies have the potential to improve data quality, leading to better outcomes.

With enhanced trial access across all demographics, study data will be more comprehensive for greater insight into developing new treatments. The end result will be improvements in trial speed, which will drive more novel therapies to patients faster and with greater cost efficiency.

Bring the trial to the patient with in-home and alternative site clinical solutions

Decentralised and hybrid trials allow patients to stay safely in their homes, while still having access to potentially life-altering new therapies. Through home healthcare and other alternative site solutions, nurses can perform assessments, such as blood pressure, ECG and phlebotomy services, within a patient’s home.

This model improves patient-centricity by reducing the burden on study participants, while leveraging technology to enable quality site/patient interactions. Moreover, deploying healthcare professionals who are trained to carry out a wide range of services and tests in the patient’s home can reduce anxiety, and increase comfort and convenience, while ensuring compliance and data collection.

Also, using in-home services can reduce the risk of patient drop-out, enhancing retention. Additionally, participants can be continuously monitored using wearables, electronic diaries and telemedicine, allowing sites to respond in real time and engage directly with patients more often, even identifying early symptoms that could turn into adverse events later in a trial.

Identifying the development of symptoms has the potential to not only mitigate symptoms, but also improve patient safety and avoid losing participation – especially if the incident was not caused by the investigative product.

Adopt agile remote monitoring to keep trials on track

During COVID-19 the adoption of remote monitoring increased due to site closures and patient safety precautions. In fact, response to the restrictions resulting from the pandemic led to the FDA advising sponsors to consider using central and remote monitoring programmes to maintain oversight of clinical sites.

Using an enhanced centralised monitoring data analytics platform, off-site monitoring can be equally as effective as on-site monitoring. Centralised monitoring data analytics can detect any data anomalies in real time, thereby preventing repeated errors at the site from an early stage.

Implementing a robust and flexible monitoring strategy can increase efficiency and cost-effectiveness. For example, assuming a clinical research associate can get full access to source notes, the cost of monitoring could be reduced by approximately 40% – accounting for travel costs – when the monitoring is conducted off site as opposed to on site.

Decentralisation in the decade ahead

By implementing decentralised elements that put patients first into a clinical trial, sponsors and providers can reap the benefits of more accurate data, increased patient recruitment, better patient engagement and accelerated trial execution.

Further, sponsors will continue to innovate – creating new trial designs that work best for each protocol – making decentralised and hybrid trials easily scalable.

Even as sites resume operations amid COVID-19, 84% of respondents plan to increase their use of decentralised or hybrid trials in the next two years, according to Informaconnect’s Decentralized and Clinical Trials Report 2020.

The end of 2020 has seen sponsors, sites and participants alike recognising lower burdens to participating in these types of studies and realising how technology enables, rather than hinders, operations and remote monitoring.

Marie McCarthy is Senior Director Product innovation at ICON

In association with

15th January 2021

From: Research

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