Decentralized Clinical Trials (DCTs) indicate a shift towards greater decentralization in clinical research. Consequently, studies are now being conducted across several locations instead of a single centralized site – with an increasing trend in this practice observed.
DCTs are applicable for all types of studies ranging from phase I through IV and observational research. This article will explore the advantages these trials offer participants and researchers.
Decentralized Clinical Trials are on the Rise
Clinical trials distributed have been introduced to increase accessibility. These types of trials utilize innovative technology to simplify the process involved in conducting and disseminating information, which has traditionally posed difficulties.
Decentralized clinical studies can be facilitated by either blockchain or other types of dispersed databases. Therefore, enrolled individuals from any location with internet connectivity may readily participate in decentralized clinical research.
Approaches to Accessibility in DCT
Decentralized Clinical Trials offer greater accessibility for participants as they require fewer steps than traditional trials. In typical approaches, individuals seeking to participate would need to locate a trial (which may not be in their vicinity), complete documentation, and await confirmation from the researchers indicating continued interest.
If confirmed, more communication by phone or email is needed until appointment when travel back into town (or extensive flying across country) becomes necessary to sign up as an experimental subject. All of this under supervision of scientists who are yet unfamiliar with one’s traits.
Participate in Decentralized Clinical Trials
One of the benefits of decentralized clinical trials is that they eliminate barriers to access by publishing all pertinent information online. This means anyone, even those without prior knowledge or experience in the field, can easily review and compare available experiments simultaneously. To participate, interested only need to visit our website and schedule a demo of Milo Data Platform.
Milo DCT enables you to create your clinical study without programming expertise. Its user-friendly and intuitive interface utilizes a simple “drag and drop” approach, making it possible for you to build your study effortlessly with just a few clicks. The Milo DCT solution can cut down the average study preparation time from 12 weeks (about 3 months) to just 2 days, resulting in critical time savings.
Main Advantages of Decentralized Clinical Trials
Increased Participant Accessibility
Participants have greater accessibility as they can choose their participation in studies without awaiting authorization from an institution. For instance, if you get diagnosed with type 2 diabetes and aspire to participate in a research study connected with it. However, due to your blood sugar levels being inadequate for traditional clinical trials exemption criteria but still feel inclined towards advancing medical knowledge and are willing to help, then you can register yourself on suitable platforms such as decentralized systems using phone applications designed specifically for people like yourself.
Improved Efficiency for Researchers
This also elevates efficiency since researchers save time that would otherwise go into gathering data about eligible vs ineligible candidates before initiating projects, reducing costs simultaneously.
Enhanced Flexibility
Compared to conventional clinical studies, they offer greater flexibility by facilitating access through diverse platforms such as smartphones. This proves advantageous when performing real-world experiments that involve swiftly evolving conditions on social media and the like.
Simplified Research Procedures
Clinical trials that are decentralized can simplify research procedures and enhance participant accessibility.
Advantages for Key Stakeholders
Researchers
Using DCTs can facilitate the management of larger groups of participants compared to traditional clinical trials. Also, DCTs offer a solution for low-resource settings by allowing access to globally conducted studies and local data collection. Collaborative efforts between experienced professionals and newcomers in disease-specific fields are also enabled through real-time progress feedback on an online platform provided by DCTs.
Sponsors
Decentralized clinical trials facilitate sponsors with location selection authority and provide global patient accessibility through virtual platforms, while also improving efficacy and cutting down expenses in comparison to conventional research models.
Regulatory Authorities
Regulatory authorities possess stringent regulations on the participation of subjects and study conduct location. Leveraging decentralized models will grant regulatory bodies more tolerance to assess if qualified candidates satisfy specific criteria (like age restrictions).
How Decentralized Trials Operates
Decentralized trials involve many sites each with their own trial coordinator, participants and staff, and specialized Clinical Research Associates (CRA) and software to gather data. This approach contrasts with the centralized method where all activities occur at one location.
A decentralized trial necessitates each site’s processes being approved by the sponsor before they commence recruiting patients for the study. The sites are given some tolerance in patient recruitment procedures, but only if adhered to general guidelines concerning eligibility criteria (inclusion/exclusion) and collection of data on characteristics such as age or gender at enrollment. This information will be used when analyzing results across all sites using statistical methods like meta-analysis.
The Prevalence of Decentralized Trials
The utilization of blockchain for organizing and managing data characterizes a decentralized clinical trial. This approach eliminates the need for centralized entities like Institutional Review Boards or Ethical Committees to oversee the entire process, enabling participants (referred to as “subjects”) to engage in studies independently with their healthcare providers. As opposed to seeking approval from an authoritative body, individuals can join at any time and actively participate without delay by simply joining the network.
Concluded remarks
In conclusion, decentralized clinical trials present an encouraging approach for conducting research. They have the potential to gather data more effectively compared to conventional studies and grant greater autonomy over participation and confidentiality to individuals. These benefits render decentralized trials a desirable choice for investigators and subjects.
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