Introduction To Decentralized Clinical Trials

Introduction To Decentralized Clinical Trials

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By Shane Garcia

Thanks to blockchain technology, we see a whole new world of research and development emerge. If you’re interested in starting a decentralized clinical trial (DCT), it can be daunting to learn about the process and figure out how to get started.

A decentralized clinical trial is a new type of clinical trial in which clinical research data is stored and shared directly between patients and research institutions.

In this post, we’ll discuss the key components of a decentralized clinical trial and how it works. We’ll also cover the top tools offered by companies like ObvioHealth (https://www.obviohealth.com/resources/decentralized-clinical-trials-a-comprehensive-synopsis) for running a decentralized clinical trial from start to finish.

Overview of Decentralized Clinical Trials

Decentralized clinical trials are different from virtual or remote clinical trials since they involve actual participants. However, they share the same model working model, using technology as the intermediary.

The onset of the COVID-19 pandemic forced health practitioners to revise their participant-researcher engagement by limiting physical meeting clinical trials.

Despite the setback, the decentralized clinical trials the FDA advised gives the intended outcome but less human interaction.

There are 2 versions of DCT; Full DCT and Hybrid DCT.

In a full DCT, the participant receives research gadgets and instructions to their home. They fill in the questionnaire through a digital health system, and the samples are collected and delivered to a laboratory.

Hybrid DCT brings together full DCT and centralized clinical trials. The participant can walk to a sample collection and investigation center, but the clinical researchers have less access.

The Hybrid DCT is a commonly used approach since it not only reduces the operation cost but also keeps an eye on the trial participant.

However, both systems use the same regulatory guidance, monitoring technology and gives the same data quality.

Breaking Down The Decentralized Clinical Trials Process

The entire clinical research depends on technology. Each digital endpoint (participant and the research institute) has interfaces to collect and interpret data.

eCOA (Clinical Outcome Assessment), Glucometers and medical stopwatches are some of the gadgets used in the decentralized clinical process. They form a trial design based on the sample size and disease under study.

From 2019, FDA and other medical research institutions formed a research alliance whose main aim was to contain the COVID-19 pandemic. It catapulted the institutionalization of decentralized clinical trials since the disease was infectious and contagious.

Since data volume and confidentiality are top priorities, most medical research facilities prefer Oracle Cloud. It is one of the best ICT firms in the world.

They customize data collection and monitoring technology for easy interpretation. The outcome is vaccines and other medical procedures that will keep people safe.

Five Advantages Of Decentralized Clinical Trials

1. Data Accuracy

First, the trial participant directly provides the required data. Secondly, researchers can replicate the methodology to capture a bigger size sample. The bigger the size sample, the more accurate the data collected.

2. Participant Can Go on with their Daily Routine

Pitting centralized vs. decentralized clinical trials, the difference in structure, especially on participants’ availability, is vivid. Centralized trials mean participants and the whole trial procedure happen in one place.

However, the decentralized approach keeps the participant in their homes where they can go on with their lives while undertaking the research.

3. The Clinical Trial Focus is on the Participant

Decentralized clinical trial companies designed this procedure with the participant in mind. It gave them the freedom and space to continue with their lives as they undertook the research.

It also works well for participants who have mobility issues or those who live far from the clinic.

4. Saves Time

When participants and researchers align, the system can receive multiple entries at the same time. Every participant has an account where they feed in the data based on their experiences.

It is an improvement since researchers in centralized trials attended to participants one at a time.

5. Value for Money

Research facilities can use the digital biomarkers in several decentralized clinical trials. In this case, it caters for recurring costs in subsequent trials, lowering the production cost significantly in the long run.

As much as the digital clinical trials have many benefits, it also affects the whole process in the following ways:-

  • Data privacy – some countries haven’t institutionalized data privacy, hence anyone can access the data. Also, some data servers aren’t secure enough to wade off hackers.
  • Physician-Patient interactions – some procedures require patient-physician interaction, rendering the process incomplete.
  • Regulations setbacks – before any research, the government must approve the procedure. The legislation process that formalizes the procedure is usually slow, which wastes time, especially if there is a global pandemic like COVID-19.
Shane Garcia

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