As technology advances and evolves, there’s been an increasing push for more patient-centric, efficient, and transparent research. To help facilitate this push, decentralized science, or DeSci, has been one of the most transformative and exciting developments in the intersecting worlds of science, technology, and tokenization — helping to create the necessary convergence for decentralized clinical trials (DCTs).
By leveraging decentralized technologies, particularly blockchain, Web3 digital platforms, and remote monitoring tools, such as wearable health technology, DeSci has the potential to address long-standing challenges in clinical trials. We’ll explore some of the pain points that typically plague conventional clinical trials and the five major ways that DeSci offers real, tangible solutions that address these challenges. If conducted properly by talented and dedicated researchers, decentralized clinical trials can be more efficient, inclusive, secure, and cost-effective.
1. Decentralized Clinical Trials Can Improve Recruitment and Retention
Recruitment and retention are often the most challenging, headache-inducing parts of clinical trials. Often, traditional research trials are limited by eligibility criteria, geographical constraints, and rigid timelines. For example, if researchers conduct a clinical trial that relies on in-person appointments, trial recruitment may be limited to participants who live within a certain radius. This narrows the participant pool to geographical restraints, which may affect the pool’s diversity. When it comes to research, a lack of diverse populations within a study can easily lead to biased results.
Also, trials relying on traditional clinical trial sites and in-person visits will always have bad retention rates. While, of course, some trials may require in-person participation, not all do, and adding unnecessary hurdles will always affect a researcher’s ability to retain trial participants. For one reason or another, a person may be unable to make it to a specific place at a specific time. Not only do bad retention rates waste a researcher’s money, time, and resources; but unreliable participation can also cause an entire trial to fail.
DeSci Solution: Many decentralized clinical trials enable participants to enroll remotely, eliminating the need for traveling to specific trial sites. Researchers can recruit through online registries by leveraging digital platforms, reducing geographical barriers and expanding the population pool. Blockchain and other digital tools also help streamline the consent process, making it easier for patients to join trials, stay informed, and remain engaged over the study’s duration.
DCTs also typically allow for continuous remote monitoring of participants’ health via wearable health devices or mobile apps, improving data collection while reducing the need for frequent site visits. For example, A+ Voice by AxonDA0 allows participants to continually provide biomarker data by simply speaking into their phones. This technology-enabled flexibility can significantly improve retention.
2. Enhanced Data Transparency and Integrity
Data integrity and transparency are cornerstones for conducting a successful clinical trial. Unfortunately, in traditional models, data may be siloed, manipulated, or lost due to human error and a lack of transparency. Finally, multiple entities may handle the same clinical trial data, depending on the trial’s progress. These entities — each with their own motives and perceptions — may include trial sponsors and investors, contract research organizations (CROs), and on-site clinicians, increasing the risk of inconsistencies and discrepancies as data moves between stakeholders.
DeSci Solution: Blockchain technology, a key component of DeSci, can revolutionize the way clinical trial data is handled. Blockchain provides a decentralized, immutable ledger where all trial data can be securely recorded. This can ensure transparency and traceability. Each data point, whether it’s patient’s records, treatment processes, or adverse event reports, can be timestamped and securely stored, helping to ensure data integrity.
By using blockchain, all parties involved could access research data in real time. This can help reduce reporting delays while ensuring everyone is working from the same information. This level of transparency can prevent fraud, increase trust in each part of a trial’s process, and improve the credibility of a trial’s outcome.
3. Cost Reduction and Efficiency Gains
Due to the high cost of in-person visits, recruitment, and trial management, traditional clinical trials can be astronomically expensive for researchers. For example, the cost of developing a new drug can run into the billions, and the R&D aspect of clinical trials accounts for a significant portion of this cost. For independent researchers without substantial backing, this cost can be prohibitive.
DeSci Solution: DeSci is designed to reduce the cost of clinical trials in several ways. By decentralizing the trial process and utilizing digital health technologies, the need for physical trial sites is greatly reduced. Digital platforms and tools enable remote patient monitoring, data collection, and management.
Additionally, decentralized trials can increase operational efficiency by automating tasks such as patient enrollment, consent management, and data collection through the use of smart contracts and AI-driven analytics. These improvements can accelerate the timeline of trial activities, potentially leading to faster delivery of insights and therapies.
4. Faster Regulatory Approvals and Faster Time to Market
Regulatory agencies, such as the FDA, have always been slow to adapt to new technologies, which is a problem as new technologies are becoming exponentially more useful and powerful. However, with the rise of DeSci, there is a growing recognition of the potential applications of various technologies and the benefits of a decentralized approach. In truth, once regulators become acclimated to DeSci and its benefits — such as better data transparency, security, and more efficient patient monitoring — regulators should be better equipped to track progress, approve changes, and oversee clinical trials. “Should” is the operating word here.
DeSci Solution: By providing real-time access to trial data through the integration of blockchain and other decentralized technologies, DeSci can expedite the regulatory approval process. Information can simply be audited more easily. In addition, since researchers can track outcomes continuously, instead of waiting for periodic reports, they can create more adaptive trials. This, in turn, can help speed up trial phases, leading to faster market approval of therapeutics and offering us quicker access to innovative treatments.
5. Improved Patient-Centered Care
Patient-centered care is the North Star for many clinicians. However, it’s almost impossible for researchers to personalize conventional trials, as the process can be complex, burdensome, and, as previously mentioned, costly. However, decentralized clinical trials can place patients at the center of the process.
DeSci Solution: By utilizing new technologies, such as wearable health tech, patients can participate in clinical trials without leaving their homes. When data collection is more consistent and frequent, researchers can gain deeper insights into patient experiences and outcomes. This patient-centric approach also empowers participants by giving them more control over the trial process, improving overall engagement and satisfaction.
From enhancing patient recruitment to reducing costs, decentralized clinical trials can make clinical research more efficient, inclusive, and patient-friendly. Moving forward, DeSci will continue to mature, leading to evolving regulatory frameworks. And, if DeSci continues to prove its use case for helping to create a healthier society, then decentralized clinical trials will likely become the standard rather than the exception.
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