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Decentralised Trials: The Way of the Future

An i-Pharm Blog

August 2022

Decentralised Trials: The Way of the Future

What is a Decentralised Clinical Trial?

There are many words to describe the concept of decentralised clinical trials (DCTs), including distributed, home-based, virtual, remote and site-less. Whichever term your organisation may choose, the goal remains the same: to ease participation for patients by reducing or eliminating the need to travel to major clinical facilities.

During a DCT, the patient receives medicine at home, and vital signs are recorded using remote or wearable patient monitoring devices. By bringing care directly to patients, the trial can be conducted from the comfort of their home, building convenience and flexibility into the process. There is no need for travel, nor the pressure to attend medical facilities, even for the initial paperwork, which can all be completed through electronic consent. 

The growing need for decentralised clinical trials

The Covid-19 pandemic disrupted many trials that were potentially bringing new therapeutics to market and brought the need for greater innovation and modernisation across the pharmaceutical industry into focus. The adoption of virtual interactions between physicians and patients to provide continuity of care while maintaining social distancing has significantly catalysed the adoption of DCTs.

The pandemic has shown us what is possible in the use of innovative technologies, permitting those interactions using “virtual elements”, for example, by adopting remote consent, videoconference assessments, smartphone health applications, and remotely connectable health monitoring devices. 

The pandemic has shown us what is possible in the use of innovative technologies

With the option to interact with clinical study staff either at home or in more convenient locations, the patient experience, which is paramount to the overall success of any clinical trial, is enhanced since DCTs reduce the time and financial burden on patients, accelerating patient enrolment and reducing drop-out rates.

This also extends the opportunity for people living in rural communities, as well as people from ethnic minority groups to take part, opening recruitment to a wider patient pool and making sure the population for whom a treatment is being developed is fairly represented, therefore democratising and humanising clinical trials. Together, these factors reduce study costs and help get medications to market more quickly.

Looking to a decentralized future

The pandemic has accelerated acceptance by medical professionals that new remote monitoring technologies and devices can, and should, be used to safely conduct DCTs whenever possible. Both large and small pharmaceutical companies across the globe including PPD, Parexel, IQVIA and ICON to name a few, are already seeing the rewards from DCTs.

However, this unconventional method that depends primarily on the effectiveness of its technology means that companies must focus on building a solid and modernised technology foundation that encompasses the collection, review, management, analysis, and visualisation of the trial data, to provide interoperability in information exchange.

To truly enable DCTs, we need new thinking. Will we see more companies supporting Decentralised Clinical Trials?

 

i-Pharm Consulting is a leading provider of staffing services in the Clinical space working with a large range of Pharmaceutical, Biotechnology and Contract Research Organisations.

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