The role of decentralized approaches in clinical trials

Decentralized approaches to clinical trials have been cited as a key trend in the industry for many years. However, the COVID-19 pandemic resulted in a rapid acceleration of the trend. A recent report by Clinical Trials Arena using data analysis by GlobalData[1] found that a “record number of around 1,300 trials with a decentralised and/or virtual component will likely initiate in 2022” – up 28% from 2021.

TELEMEDICINE AND DIGITAL DATA COLLECTION FASTEST GROWING SEGMENTS OF DECENTRALIZED APPROACHES

According to recent data – the use of home-based or alternative sites for clinical trials, including remote drug delivery and home patient care, is still rarely used, with only 34 recently initiated trials including these elements identified in 2021. However, the use of telemedicine and digital data collection is growing fast- GlobalData identified 220 clinical trials using digital data collection in 2021 in comparison to an average of 20 per annum between 2010 – 2016. The use of eConsent also continues to grow[2] largely driven by an increase in use among contract research organizations (CROs).

DECENTRALIZED APPROACHES OFFER SIGNIFICANT BENEFITS FOR SPONSORS AND PATIENTS

Decentralized approaches offer significant benefits for Sponsors and patients by offering an alternative model of trial participation.

DECENTRALIZED APPROACHES ADVANTAGES:

  • Faster recruitment of patients
  • Convenience for patients and caregivers
  • More information collected more frequently
  • Possibly lower research cost
  • Higher data quality
  • Reducing the infection risk to all parties during pandemics

BRINGING CLINICAL TRIALS TO PATIENTS AND IMPROVING DATA

While decentralization may not completely replace traditional models it offers great potential for helping to address the issue of patient recruitment especially in rare diseases affecting small populations across wide geographic areas.

These approaches may also help with patient retention by effectively bringing the trial to them and so reducing accessibility and travel burdens. In addition, harnessing digital technologies may also improve data quality as data collection can be continuous throughout studies.

CHALLENGES

There are still some challenges to be overcome with regard to decentralized approaches to clinical trials concerning regulatory issues, disparities in infrastructure across regions, and last but not least privacy and data protection concerns.

OBSTACLES TO UPTAKE OF DECENTRALIZED APPROACHES:

Lack of generally accepted regulatory rules
Use of remote communications requires consideration of data privacy, patient confidentiality and confirming patient identities
Significant variability of infrastructure between regions for: collecting data directly from patients, visits, drug logistics, biosamples logistics

DECENTRALIZED APPROACHES TO CLINICAL TRIALS SET TO STAY

However, the potential benefits of decentralized approaches to clinical trials in terms of time and cost savings are too great to ignore. It is therefore likely that the uptake of these approaches will increase significantly in the coming years.

[1] https://www.clinicaltrialsarena.com/analysis/2022-forecast-decentralised-trials-to-reach-new-heights-with-28-jump/

[2] https://cromospharma.com/news/news/526/

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