Developing new drugs to address the wide range of conditions that affect patients is a critical and ongoing priority in the medical field. This multibillion-dollar industry involves a wide range of stakeholders, including pharmaceutical companies, regulatory bodies, manufacturers, healthcare providers, and other key participants dedicated to discovering and developing innovative therapies.
There are many factors that affect the successful and safe discovery and development of drugs. Chief concerns involve transparency, data security, and traceability, presenting many unique challenges for the multiple stakeholders involved.
Blockchain is one technology that offers huge benefits to transparency, traceability, provenance, and confidence in the efficacy of new therapeutics entering the market. This article will explore how blockchain is being used for this critical undertaking in biomedical science and the pharmaceutical industry.
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Transparency Through Transformation: Blockchain Explained
Blockchain is a potentially transformative technology. Better known as the central technology that has made cryptocurrencies such as bitcoin possible, it has seen emerging applications in a wide range of fields such as data security, AI, the Internet of Things, archaeology, medicine, and supply chain monitoring.
Data is stored on a distributed digital ledger where it can be recorded and traced. Blockchain differs from conventional databases as it is completely decentralized, with many identical copies of the same blockchain database stored across a network.1 When new data is added, a new block is created, with all copies of the ledger on the network updated to reflect the same information.
The security and transparency of the blockchain’s database of information is ensured as the majority of “nodes” (individual computers) must verify and confirm the new data’s legitimacy. When consensus is reached, the new “block” of information is permanently added to the chain, hence creating the blockchain, with the data available to all users. There are both private and public blockchains.1
Revolutionizing Drug Development
Transparency is vitally important for drug development as the field impacts public health. If errors happen during development, the cost in terms of human life, health, and financial penalties for drug development companies and healthcare providers can be prohibitive.
Regulatory bodies prioritize openness and transparency when it comes to instilling public confidence in a new drug’s efficacy and safety. Records on how a decision was made during the development process are vital to ensure the integrity of the process.2,3
Blockchain can ensure transparency as all transactions are permanently available and accessible to users without the need to consult centralized bodies. Intermediary levels are removed which ensures quick transmission of information. No humans are involved in the automated verification process, thereby removing potential error and bias.4
The drug development process can be inherently chaotic (at least initially) due to challenges such as optimizing drug behavior, discovering unknown requirements, and identifying potential side effects over the period of a drug trial, which can take years to complete. Blockchain technology can help to clear up some of this chaos by providing permanent and verifiable records without human intervention.4
Utilizing this innovative technology can ensure the proper tracking of clinical trial data such as potential side effects and cohort data, ensuring the integrity of supply chains, and improving overall data security. Once a new block of data is added to the chain, it is immutable and cannot be changed, ensuring transparency and traceability.
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From Promise to Practice: Real-World Applications
In recent years, there has been a significant and consistent increase in research interest related to the use of blockchain technology in the biomedical industry. A paper published in Blockchain analyzed the current state of the field, noting an increase from three articles in 2018 to 47 in 2022.5
Healthcare-Chain combines blockchain with AI and other Industry 4.0 technologies to ensure supply chain integrity by creating a decentralized record of transactions, which helps manage the drug supply chain. The successful implementation of this comprehensive solution could have knock-on effects for many other areas, including drug discovery and development.
Another paper published in Computers & Industrial Engineering6 in 2023 discussed a Hyperledger blockchain and machine learning-enabled solution. The approach explored in the paper can improve the robustness and transparency of drug discovery supply chain management, meaning that stakeholders can be more confident in trial results and drug safety and efficacy.
The solution discussed in the 2023 paper incorporates a web interface and test APIs, an issue contribution certificate module that helps prove contribution ownership. The authors have stated that the solution’s design is scalable.
Challenges and the Road Ahead
The road ahead for blockchain technology in drug development is bright, but not without some key challenges that researchers must address. As it is an emerging technology, there are likely to be many roadblocks ahead, some of which have not even been properly realized by stakeholders.
One of the main obstacles is healthcare data diversity, with many structured and unstructured healthcare data sources, such as electronic records and medical images, just two prime examples. Standardization is urgently needed to ensure the proper and effective incorporation of blockchain technologies in the drug discovery process.5
Data integrity and security are also prime concerns with blockchain use. Sensitive healthcare information must only be available to authorized professionals. Interoperability between different systems is also a challenge, as scalability and regulatory compliance, which will require robust compliance mechanisms.5
A Brighter Future for Drug Discovery?
Blockchain is still an emerging technology that has several associated challenges. However, this solution's potentially transformative benefits for healthcare areas such as drug discovery and supply chain management in terms of transparency, confidence in data, traceability, and other key areas cannot be understated.
Increasing research interest in this technology attests to its importance and potential to revolutionize drug discovery.
Comprehensive collaboration between multiple healthcare stakeholders, professionals in blockchain-related industries, and government regulatory bodies will be necessary to realize blockchain's full potential in the healthcare industry.
References
- Rodeck, D & Adams, M (2023) Understanding Blockchain Technology [online] Forbes. Available at: https://www.forbes.com/advisor/investing/cryptocurrency/what-is-blockchain/ (Accessed on 5 June 2024)
- Papathanasiou, P et al. (2016) Transparency in drug regulation: public assessment reports in Europe and Australia Drug Discovery Today 21:11 pp. 1806-1813 [online] Sciencedirect.com. Available at: https://www.sciencedirect.com/science/article/pii/S1359644616302434 (Accessed on 5 June 2024)
- Bradley, S.H et al. (2020) Reducing bias and improving transparency in medical research: a critical overview of the problems, progress and suggested next steps J R Soc Med 113:11 pp. 433-443 [online] PubMed Central. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7673265/ (Accessed on 5 June 2024)
- Omidian, H et al. (2023) Tracing drugs from discovery to disposal Drug Discovery Today 28:5, 103568 [online] ScienceDirect. Available at: https://www.sciencedirect.com/science/article/abs/pii/S1359644623000545 (Accessed on 5 June 2024)
- Taderhoost, H (2023) Blockchain and Healthcare: A Critical Analysis of Progress and Challenges in the Last Five Years Blockchains f(2) pp. 73-89 [online] mdpi.com. Available at: https://www.mdpi.com/2813-5288/1/2/6 (Accessed on 5 June 2024)
- Sharma, N & Rohilla, R (2023) A novel Hyperledger blockchain-enabled decentralized application for drug discovery chain management Computers & Industrial Engineering 183, 109501 [online] ScienceDirect. Available at: https://www.sciencedirect.com/science/article/abs/pii/S0360835223005259 (Accessed on 5 June 2024)
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