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By Garri Zmudze, managing partner and cofounder, LongeVC

Clinical research faces the challenge of transforming breakthrough ideas into tangible solutions. Luckily, decentralization sets the stage for a new approach to the field. Decentralization carries multiple definitions within the clinical trial space. Decentralized trials (DCTs), most familiar to clinical researchers and explored further below, refers to decentralization in terms of location and study site. It removes the need for frequent in-person clinic visits and encourages patient participation. Decentralization is not only a breakthrough in trial design but also in the larger field of scientific research and represents a paradigm shift in the digital world. It drives patient empowerment, trial accessibility, and new fundraising models.

Decentralized trials enable remote participation in and democratize access to clinical research studies. Traditionally, identifying and securing trial participants is one of the most significant challenges in clinical research. Participants have to meet study criteria and be willing to undergo treatment. Whats more, location and clinic requirements often influence participant interest. Studies with regular clinic visits could be less attractive than those with digital data-sharing options. In-person studies also limit participation from individuals outside the clinics surrounding areas. Geography not only limits participation directly, but it also adds a cost-related inaccessibility layer.

DCTs are also especially beneficial for diseases whose nature makes it difficult to generate data and observe patients. For example, rare diseases have small data pools due to patients spread across the globe. Researchers found DCTs to be an an innovative and patient-centric way to reduce the burden of clinical trials on patients, caregivers, and clinical researchers, especially for the rare disease population.1

Regulatory bodies worldwide are acknowledging their positive impact. The FDA included decentralized trials in its guidance document for enhancing the diversity of clinical trial populations.2 In the EU, the regions clinical trials coordination group coordinated the publication of DCT best practices. They describe DCTs as making clinical trials available to a wider demographic of participants and [reducing] drop-out rates.3

However, the global nature of clinical trials presents both opportunities and challenges. Collaborative and decentralized efforts among international researchers, healthcare professionals, and industry stakeholders can accelerate discoveries. At the same time, the sector must navigate challenges such as varying regulatory requirements, cultural differences, and logistical complexities. DCTs offer a path forward but still need further clarity and attention to succeed. Study sponsors should view them as a resource in improving clinical trial setup and outcomes.

The second type of decentralization connects with a movement called DeSci, or decentralized science. Introduced by the blockchain community in the 2010s, DeSci calls for increased collaboration and transparency in scientific research.4 It encourages community participation and offers an alternative to data silos controlled by centralized entities. The movements goals include open and accessible research publications, starting with collaborative sites like OpenCitations and ResearchHub, public participation in research, and new streams of project funding. Well-known DeSci initiatives include Molecule, a group developing decentralized protocols for IP, Lifespan.io, a longevity platform crowdfunding anti-aging research, and the Longevity Science Foundation, a nonprofit organization encouraging donor participation in funding decisions.

What sets DeSci apart from other open science movements is its leverage of blockchain technology. While many associate blockchain with digital currencies or nonfungible tokens (NFTs), it is a powerful technology with diverse applications. Blockchain is a form of decentralized ledger technology (DLT), the foundation of the decentralized internet movement called web3. DLT creates a secure and immutable record of transactions, where nodes validate all information and reach a consensus about the ledgers accuracy.5 It is a new way to collect and analyze data, whether for Bitcoin trading or securing patient health details.

In the evolving clinical trial landscape, the patient is no longer a passive participant in the research process. Engaging patients as partners can improve study outcomes and increase participant satisfaction. Luckily, decentralized technology can improve patient engagement and encourage study completion.

Besides increasing trial accessibility as mentioned above, decentralization harnesses the power of blockchain technology to secure and anonymize patient data. Decentralization places power in the hands of individuals. Some patients may worry about sharing their data with large pharmaceutical companies.

If individuals can share their data more efficiently through DCTs, protecting these data will be vital, especially with digital data sharing. Consent is also essential here. Technology must account for the ethical and regulatory framework surrounding clinical trials. As technology advances, participants' rights and privacy become increasingly important. Striking a balance between innovation and ethical considerations is crucial. Regulatory bodies must adapt to the evolving landscape, addressing emerging challenges while maintaining integrity and safety.

Blockchain is a key component in this discussion, as it provides a secure and immutable record of transactions. It empowers participants to track their data in real time. They will know physicians are accessing their information securely. They also can withdraw their consent anytime, with no complicated forms required. Their decisions will be recorded on the blockchain, making it accessible to all study stakeholders. Dynamic consent will grant participants unparalleled control over their data.

Trial funding remains a concern for clinical researchers worldwide. Amid a biotech winter, many worry about progressing research while the economy struggles. Funding options from the decentralized world offer a promising alternative.

Clinical research and the web3 community have an intertwined past. Web3 refers to the decentralized movement for the internet, where users (rather than corporations) own their data. In 2018, Vitalik Buterin, the cofounder of the popular digital currency Ethereum, donated $2.4 million in Ethereum (ETH) to the SENS Research Foundation, a California-based group working on researching, developing, and promoting comprehensive solutions for aging-related diseases. Buterin also has donated $25 million in Shiba Inu (SHIB) tokens to the Future of Life Institute to fund Ph.D. fellowships focused on ethical AI applications and millions of dollars to the Methuselah Foundations research on tissue engineering to reverse the aging processes.

Buterins support for clinical research has set a valuable precedent for other web3 KOLs to take an active role in the space. Many healthcare nonprofits, including the Alzheimers Association, the Diabetes Research Institute Foundation, and the American Cancer Society now offer crypto donation options to encourage support from the community.

Healthcare organizations also have created NFT collections to tap into the crypto fundraising wave. Noora Health, an organization focused on empowering at-home caregivers, sold its Save Thousands of Lives NFT for 1.3k WETH, or $4.4 million. Similarly, Professor George Church of Harvard University is planning to offer his genome as an NFT hosted on a decentralized server. His genome was one of the first to be sequenced, making it significant for the clinical research community.6 Similar applications could provide a new way for participants to monetize their data by selling NFTs to study sponsors.

Decentralized funding for clinical research projects helps bring even more of the public into the funding process. It can help raise awareness around study recruitment and participants and encourage new groups, including crypto enthusiasts, youth, and web3 founders to support the field. The nature of finance is changing, and decentralized funding offers a way to meet changing demographics.

Were on the brink of a new era in clinical trials, where decentralization will transform recruitment, compensation, and funding. The outcome? More efficient, inclusive, and effective processes for the space. While we are only at the beginning of this journey, one thing is sure: The impact of these technologies will resonate far beyond the realms of research. Decentralization is here to stay and will shape the future of healthcare.

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About The Author:

Garri Zmudze is an investor and advisor for deeptech companies developing life-changing solutions across biotech, medicine, longevity, and more. Garri is committed to building a world where everyone has more healthy years with their loved ones. He cofounded the Longevity Science Foundation, a global nonprofit funding early-stage research on extending the healthy human lifespan, in 2021. Garri is also cofounder and managing partner at LongeVC, a venture capital firm investing in visionary biotech and longevity. Outside of his work with LongeVC, Garri is one of longevitys top angel investors and has had several successful exits across biotech and emerging tech. Garri is also an advisor for top companies across web3 and biotech.

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Decentralization It's More Than You Think - Clinical Leader