1. Defining Decentralised Clinical Trials
Decentralised clinical trials enable distant involvement in clinical research studies and democratise access to them. Historically, one of the major obstacles in clinical research has been recruiting and securing trial participants.
Participants must fulfil the study’s eligibility requirements and be willing to undertake therapy. Moreover, participant interest is influenced by geography and clinic needs. Regular clinic visits may be less appealing than studies with digital data-sharing opportunities. Those from outside the clinic’s surrounding areas are likewise barred from participating in in-person research. Location not only directly restricts participation, but also adds a layer of cost-related inaccessibility.
DCTs are particularly useful for disorders whose nature makes data generation and patient observation challenging. Rare illnesses, for example, have tiny data pools due to patients being distributed around the globe. DCTs were discovered by researchers to be “an innovative and patient-centred strategy to lessen the burden of clinical trials on patients, carers and clinical researchers, particularly in the rare illness population”.
Regulatory organisations all across the world are recognising the potential of APAC decentralised clinical trials. Decentralised studies were included in the FDA’s recommendation paper for increasing the variety of clinical trial participants. The publishing of DCT best practices in the EU was organised by the region’s clinical trials coordination group. According to the group, DCTs make “clinical trials available to a broader demography of participants while cutting drop-out rates”.
The worldwide aspect of clinical trials, on the other hand, brings both possibilities and disadvantages. International researchers, healthcare practitioners and industry stakeholders can expedite discoveries through collaborative and decentralised initiatives bolstered by decentralised clinical trial software. Meanwhile, the industry must deal with issues such as differing regulatory requirements, cultural disparities and logistical complications. DCTs provide a road ahead, but they require more clarity and care to succeed. Sponsors of clinical trials should regard them as a resource for enhancing clinical trial design and outcomes.
2. Defining Decentralisation in Scientific Research
The second sort of decentralisation is linked to the DeSci, or decentralised science. DeSci, a term coined by the blockchain community in the 2010s, advocates for greater cooperation and openness in scientific research. It stimulates community engagement and provides an alternative to centralised data silos.
The aims of the movement include open and accessible research publications, beginning with collaborative sites such as OpenCitations and ResearchHub, public engagement in research, and new sources of project finance. Molecule, a group designing decentralised IP protocols, Lifespan.io, a longevity platform supporting anti-aging research, and the Longevity Research Foundation, a nonprofit organisation promoting donor participation in funding choices, are all well-known DeSci efforts.
The use of blockchain technology distinguishes DeSci from other open scientific groups. While many people identify blockchain with digital currency or nonfungible tokens (NFTs), it is actually a strong technology with a wide range of uses. Blockchain is a type of decentralised ledger technology (DLT) that serves as the cornerstone of the web3 decentralised internet movement. DLT generates a secure and immutable record of transactions in which nodes check all information and establish an agreement on the ledger’s correctness. It is a novel method of collecting and analysing data, whether for Bitcoin trading or safeguarding patient health information.
3. Defining Decentralisation in Patient Data Storage
The patient is no longer a passive participant in the research process in the developing clinical trial environment. Involving patients as collaborators in research can enhance study results and participant satisfaction, removing challenges with decentralised clinical trials. In fact, decentralised technology could lead to increased patient participation and expedite study completion. Besides boosting trial accessibility, as previously stated, decentralisation uses blockchain technology to safeguard and anonymise patient data. The benefits of decentralised clinical trials are manifold:
- Increased access and participation: Traditional clinical trials often require participants to travel to specific research sites, which can be a major barrier. Decentralised trials, however, can be conducted remotely using telemedicine and wearable devices. This makes it easier for people from all walks of life to participate in research, regardless of location or health condition. For instance, someone living in a rural area with limited transportation options could still be eligible to participate in a decentralised trial for a new cancer treatment.Real-world data collection: Decentralised trials can collect data from participants in their everyday lives, rather than just during clinic visits. This can provide researchers with a more accurate picture of how a treatment works in a real-world setting. For example, a wearable device could track a participant’s heart rate and activity level to see how a new medication for heart disease affects their daily functioning.
- Real-world data collection: Decentralised trials can collect data from participants in their everyday lives, rather than just during clinic visits. This can provide researchers with a more accurate picture of how a treatment works in a real-world setting. For example, a wearable device could track a participant’s heart rate and activity level to see how a new medication for heart disease affects their daily functioning.
Some patients may be concerned about sharing their personal information with huge pharmaceutical corporations. Many decentralised clinical trial myths are making the rounds when it comes to data security, without much truth to them.
Individuals will need to secure their data if they can share it more efficiently through DCTs, especially with digital data sharing. Consent is also required in this case. Technology must consider the ethical and regulatory framework around clinical trials. Participants’ rights and privacy are becoming increasingly crucial as technology improves. It is critical to strike a balance between innovation and ethical issues. Regulatory agencies must adapt to an ever-changing environment, tackling new issues while ensuring integrity and safety.
Blockchain is an important topic in this debate because it offers a secure and unchangeable record of transactions. People will be aware that physicians are safely accessing their information. Consumers can also withdraw their approval at any moment, without having to fill out any onerous documents. Their decisions would be recorded on the blockchain, making them available to all stakeholders in the research. Participants will have unprecedented control over their data thanks to dynamic consent.
Conclusion
We are on the verge of a new age in clinical trials, one in which decentralised trial management software will revolutionise recruiting, pay and finance. What will the end result be? Processes for the space that are more efficient, inclusive and effective.
While we are still in the early stages of this adventure, one thing is certain: the effect of these technologies will extend well beyond the boundaries of science. Decentralisation is here to stay and will influence the future of healthcare.
About the Author
Hiren Thakkar, Managing Director, Octalsoft
Hiren Thakkar is dedicated to empowering businesses to achieve their goals through innovative and cost-effective solutions. He has a unique ability to implement simple solutions for even the most complex problems. With extensive industry experience, including more than a decade in pharma and clinical research, Hiren is not just an expert but a visionary who understands the potential of technology and knows how to leverage it for client success.
Website: https://www.octalsoft.com