In the world of clinical research, decentralization is becoming more and more common. As a result, we’re seeing more decentralized clinical trials—or DCTs—which are trials that are conducted at multiple locations rather than at one centralized location. DCTs can be used to conduct any type of research, including phase I through phase IV trials and observational studies. In this article, we’ll examine why they’re so beneficial for research participants and researchers alike.
The rise of decentralized clinical trials
Decentralized clinical trials are a way to make clinical trials more accessible. Decentralized trials use new technology to make the process of conducting and distributing information easier than it has been in the past. This can be done through blockchain or other forms of distributed databases, meaning that participants can get involved in decentralized clinical trials from any location with internet access.
Decentralized Clinical Trials are also more accessible for participants because they take fewer steps than traditional clinical trials. In conventional models, someone interested in participating would have to find a trial (which may not be near them), fill out paperwork, and then wait for an email from the researchers asking if they’re still interested. If so, they’d contact the researchers again by phone or email; then when it’s time for their appointment they’d travel back into town again (or fly across country) just so they can sign up as part of an experiment being conducted by scientists who may not even know what kind of person you are yet!
Decentralized clinical trials solve this problem by making all information publicly available online so anyone can see all available experiments at once without having any prior knowledge about them whatsoever! People who want participate simply click ‘sign up’ on our website, and from there, the unique private key address provided during registration will automatically load up onto a database, which allows information entered into one machine to be accessible anywhere.
How they work
Decentralized clinical trials are conducted by multiple sites. Each site has its own trial coordinator, trial participants and staff, clinical research associates (CRA), data management system, and software tools to collect the data. In this way, the decentralized trials are different from centralized trials where everything is done at one site.
In a decentralized trial, each site will have their own processes that must be approved by the sponsor before they can begin recruiting patients into the study. The sites also have some flexibility in terms of how they recruit patients as long as they follow common guidelines for eligibility criteria (called inclusion/exclusion criteria) and for collecting information about patient characteristics such as age or gender at time of enrollment into the study which will be used later when analyzing results from all sites together using statistical methods such as meta-analysis.
A decentralized clinical trial is one that uses the blockchain for its organization and data management purposes. This means that instead of having a central authority such as an Institutional Review Board or Ethical Committee managing the entire process, participants (or “subjects”) are able to participate in a study by themselves or with their doctors and hospitals. Instead of requiring approval from a central institution, they can simply join the network at any time and begin participating immediately.
Decentralized trials have many benefits over traditional clinical studies:
- They are more accessible to participants because participants can self-select into or out of studies without having to wait for approval from an institution. For example, if you have type 2 diabetes and want to participate in a diabetes research study but don’t qualify for traditional clinical trials because your blood sugar levels aren’t high enough and still want to help advance medical understanding, you can still register. You could use your phone app as part of a decentralized system where researchers would be able to send information about upcoming studies specifically designed for people like yourself! This also improves efficiency since researchers don’t have to spend time gathering information about who qualifies as eligible versus ineligible before starting their research projects (it would also reduce costs).
- They are more flexible than traditional clinical studies because they allow easier access across multiple platforms (e.g., smartphones). This can be helpful when conducting real-world experiments where conditions might change rapidly over time (e.g., social media platforms).
Decentralized clinical trials can make research easier to conduct and more accessible to participants.
Now that you understand the basics of decentralized clinical trials, you may be wondering how they could benefit researchers, sponsors and patients. Let’s take a look at each group:
- Researchers: DCTs help researchers manage larger numbers of participants than traditional clinical trials. They can also make it easier for researchers in low-resource countries or regions to access data from other studies conducted elsewhere in the world, as well as from their own communities. DCTs also allow researchers with different levels of experience (e.g., those just entering the field) to collaborate with experts on particular diseases or conditions by providing them with real-time feedback on their progress through an online platform.
- Sponsors: In addition to improving efficiency and reducing costs associated with traditional research models, decentralized clinical trials also allow sponsors more control over location selection while still allowing patients around the world access via virtual platforms like Patientory.
- Regulators: Regulatory authorities have strict guidelines regarding who can participate in studies and where they are conducted; decentralized models enable regulatory bodies greater flexibility when determining whether or not eligible subjects qualify under given criteria (e.g., age ranges).
In conclusion, decentralized clinical trials are a promising new way to conduct research. They can be a more efficient way to collect data than traditional studies and offer participants more control over their participation and privacy. These advantages make decentralized trials an appealing option for researchers and patients alike.