Everything You Wanted To Know About Decentralized Clinical Trials

What are Decentralized Clinical Trials?

However technical it may sound, decentralization simply literally means – “the transfer of control of an activity to several local authorities rather than one single one”. And that is exactly what decentralized clinical trials (DCTs) – aka “virtual” clinical trials – aka “direct-to-participant” trials – intend to do. The appeal of DCTs lies in bringing in the convenience-quotient for the patient leading to improved patient engagement, by roping in virtual technology in trial design.

History of Decentralized Clinical Trials

History of Decentralized Clinical Trials Photo Credit: @craiglipset

Decentralization of clinical trials was envisioned over a couple of decades ago by many scientists and industry experts. The first decentralized clinical trial was conducted by Pfizer in 2011, but its foundations had been laid in 2007 itself. It enrolled 600 patients from 10 states who participated in the study screening process through the Internet, actively managed their own trial activity and reported results directly to a trial investigator – all remotely. And co-incidentally, the trial was named “REMOTE” (The Research on Electronic Monitoring of OAB Treatment Experience). The study was a Participatory Patient-Centered (PPC) clinical trial designed to “remotely” assess the safety and efficacy of the drug Detrol LA, a treatment for overactive bladder. This was the first attempt to validate virtual, patient-centered approaches to clinical research. 

Even before 2011, several other groups took an attempt at conducting decentralized clinical trials – most of them being hybrid in nature. In 2003, McAllindon conducted a feasibility study for internet trials. Lily conducted a hybrid online trial (with site visits) – to test an erectile dysfunction drug called Cialis in 2004. In the same year Boston University conducted an internet based randomized controlled (RCT) study to test the effects of glucosamine in osteoarthritis. The next year, in 2005, UCSF conducted an internet based RCT testing effectiveness of Kava in patients with anxiety. In 2007, Boston university filed a patent for internet based clinical trials, while the REMOTE trial was being pitched at Pfizer internally. The year 2009 saw the launch of Mytrus – a California-based clinical technology built on the idea that modern technologies can enable people to safely participate in clinical trials without requiring them to live near a study center. 

Between 2011 to 2019 a lot many CROs, biopharma and medical devices companies joined the race such as Science 37, Novartis, Sanofi, Abiome, GSK, Medidata, Amgen, IQVIA, Verily and J&J.

Here’s a peek at how the competitive landscape looked like in 2018 – compiled by Human First (formerly Elektra Labs).

Landscape of the decentralized clinical trials market. Credit: Elektra labs

The Pandemic Push

The technological advancements required for such virtual trial platforms were already in place. However, not until the pandemic struck in 2019-2020 did decentralized trials finally gain pace. The COVID-19 pandemic simply provided that push! The need for “contact-less” operations in almost every aspect of life that the coronavirus drove us to – led to accelerated adoption and popularity of DCTs. 

Today, a riot of companies and organizations are contributing to the adoption of virtual clinical trials in various capacities, with Walgreens being a recent talked about member, aiming to use a strategy combining decentralized and conventional site-based models. This list here describes about the best clinical trial vendors in 2022 including TrialX.

How do Decentralized Clinical Trials Work to Improve Participation?

By bringing several trial activities to a patient’s home –  eliminating or reducing the need to travel to the trial sites, hence, making it easier for the patient. 

In what ways? The various process of a clinical trial such as:

  • patient recruitment and consent collection 
  • sample collection 
  • direct delivery of study drugs and materials 
  • drug administration
  • consultations
  • home visits 

are achieved using virtual tools such as telemedicine, healthcare interfaces and sensory-based wearable medical devices.

This virtual approach has: 

  • reduced patient drop-out rates
  • enabled participation from diverse populations and age groups 
  • removed geographical bias 
  • reduced paperwork 
  • increased study effectiveness
  • sped up the clinical research pipelines
  • offered unmatched adaptability and scalability

In a fully decentralized clinical trial, all procedures starting from patient recruitment, drug delivery and administration to data collection, happen without any person-to-person contact between the study team and the subject. However, most ongoing decentralized trials are hybrid that implement certain virtual elements such as online patient interactions and mobile clinics. 

Way Forward 

Technology-enabled DCTs have started to change the landscape of clinical trials. This was very much evident in the discussions at the recent #DIA2022 conference held in Chicago. Novel technologies and design frameworks are projected to further enhance the accessibility, simplicity and reliability of digitized trials. The issuance of guidelines by many regulatory bodies, including the US Food and Drug Administration (FDA), is likely to accelerate the adoption of decentralization. With adequate planning, technology, operations management, and safe deployment strategies, DCTs are the way forward for clinical research, focusing on patient-centric programs emphasizing patient welfare, as well as the comfort of healthcare professionals.

Looking for a Smooth Transition to Digitized Trials?

Now you can accelerate digitized trial pipelines with TrialX xPand. With the expansion of decentralized clinical trials, it is crucial you use the right tools to increase efficiency. TrialX is your go-to technology partner providing solutions for patient recruitment, data collection, integration and analytics. 

For more information contact us.