If I have an oracle, I imagine a world using seamless technologies that interacts with each other to do a real time analysis of all data collected of me and around me to assess my health daily. Using from IoT to AI to predict potential diseases I might develop, deliver my medication via drones when I need it, use home digital devices to assess my health without the need to go to the hospital, and more. All this is nice. However to make this possible, we need to think about the underlying technology that allows data to be shared on real-time and secure within a network, to allow for digital trust, immutability, and transparency. This is where distributed ledger technology like blockchain could ensure the above.
Back in 2017, I started exploring blockchain technology and formed the PhUSE Blockchain Workgroup with other like-minded healthcare professionals. I am also the lead for UCB on the IMI PharmaLedger project. For the pharma industry in particular the supply chain, it would provide the drug provenance and be able to track and trace from its active ingredients to manufacturing, distribution, pharmacy and last but not least to the patients. This provides the transparency and accountability, avoid counterfeit drugs, avoid drug shortage, etc. The implementation of blockchain will ease the complexity surrounding the supply chain that currently involves many stakeholders in every step.
For research, could blockchain be the solution for healthcare and clinical trials? The short answer is yes. Many sceptics have challenged me on this but look at what USA FDA, USA CDC, UK NHS, Chinese FDA, and others who are exploring and, in some cases, have implemented blockchain. Should I say more? Blockchain could provide an end to end clinical development solution. It’s blockchain coupled with IoT, data analytics, AI, and others that will help accelerate the discovery and development of new drugs. It will reduce the overall cost on drug development and therefore, reduce the cost for patients and healthcare.
It is well known that the current clinical trial process is complex and costly. As an example, we spend millions of USD within the industry to recruit the right study participants and over 1 billion USD to put a new drug on the market with the average of 14 years from research to development. Can patients wait that long if they have unmet needs? Would the payers reimburse? If not, could patients even afford it? If we focus on how to drive the cost down (efficiencies) and apply innovative solutions, we could meet in the middle. The healthcare and pharmaceutical industries should find better solutions by converging science and technology to provide the true value for patients. Collaboration in this space is the way forward.
If we look at the future state, the idea is to empower patients to own their data and bring their data into a platform where they can consent for data to be shared on-chain for research purposes. The data would be from EMR (Electronic Medical Records), omics data (genomics, genetics, proteomics, and metabolomics) to wearables, sensors, devices, etc. that might be stored off-chain. Based on the pool of data shared anonymously, the researcher can verify the inclusion and exclusion criteria as defined per the protocol. If the participant(s) qualifies, the next step is to request official participation using eConsent (electronic Informed Consent Form (ICF)). The recruitment for the clinical trial could be completed on day one. A set of data could already be collected such as EMR (using FHIR standards), omics data, demographic information, and others to speed up the data collection from study participants needed for eCRF (electronic Case Report Form). On day two, the site/patient monitoring can start, including the use of home digital devices for remote or virtual clinical trials to provide flexibility and reduce the burden for the study participants and their caregivers.
The data would be shared with a clinical trial permissioned blockchain with investigators and sites, the sponsor(s) (pharmaceutical companies, researchers, etc.), clinical research organisations, central laboratories, regulatory authorities, etc. This would ensure data integrity, transparency, interoperability, near real-time access, and additional security for all stakeholders in the network. It will provide efficiencies in the drug development process using automation, analytics, and AI to improve for example patient safety and trigger real-time notifications on (serious) adverse events to the specific parties including the country’s regulatory authorities. It could also supporton-time decision regarding de-risking the study, adaptive clinical trials, predict success rate of a study, etc. The benefits for the regulatory authorities are to reduce the need for site inspections at the end of the study but using the real-time data and AI to identify and notify GCP issues earlier on. There are many other benefits for all the stakeholders involved and the need to collaborate in this blockchain space to understand the technology and how this could improve our processes and therefore, reducing drug development timelines for allow early access of the drugs to patients with unmet needs.
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