By Maria Palombini, IEEE Standards Association
Pharmaceutical companies and research institutions are feeling the pressure to reduce the time, financial, and other resource costs associated with conducting clinical trials. With the influx of emerging applications for technologies such as machine learning, robotics and automation, and blockchain and other distributed ledger technologies (DLTs), many see a new path to more efficient and effective processes that can address the challenges faced today.
The application of blockchain and DLTs is prominent in the global dialogue as a key to innovating the clinical trials process. For the last two years, there has been discussion, along with pilots and proof of concepts (POCs), to help realize the viability of these technologies in addressing the challenges present today in clinical trials, such as patient recruitment, tracing and auditing the clinical supply chain, restoring integrity to trial data, and reducing the overall time to conduct trials.
There has also been increasing growth of consortia and alliances where competing organizations collaborate to address business and technical issues that are hindering the progress of blockchain adoption as a solution. The use cases that these alliances and consortia seek to address may differ, but they share the aim of reaching consensus around the implementation of blockchain technology to enable trusted data sharing, privacy, and security. Yet the growth of consortia and alliances may be resulting in a paradoxical outcome. One driver of the use of blockchain is to reduce or eliminate data silos; yet, we have to wonder if the formation of these many consortia and alliances could present other challenges in the future if the “chain-to-chain” solution does not get addressed.
For these consortia and alliances to be successful, they need to ensure that their participants have a clear understanding of both the immediate use case and the long-term impact on the future of healthcare. They must recognize that blockchain/DLTs are not the only tools in the innovation toolbox and that it will take more than just one technology to solve all the data challenges in the healthcare ecosystem. Blockchain and DLTs are considered disruptive technologies in that they compel industry professionals to rethink every step in the process, partnerships, and overall strategy of clinical trials. Those who have been entrenched in seeking approval to participate or conduct blockchain pilots and projects would argue that evolving to this way of thinking has been difficult.
Further, the current lack of a full on-production blockchain for clinical trials poses a larger question. With the promise of blockchain, the number of alliances and consortia created, and pilots undertaken, what is still missing to advance blockchain and DLTs adoption from concept to real-world deployment in clinical trials operations?
There are many aspects to be explored and work to be done and we know that its adoption cannot be rushed. Testing and developing trust and certainty in its application will take time. We are only a couple of years into industrial applications. The way blockchain appears or used today may be quite different tomorrow. And we need to face a reality that blockchain may never be 100 percent universally adopted.
How long will it take for blockchain to become a pervasive solution? It is still too early to predict. However, there are practical solutions to challenges that we can work on today. And this is where the IEEE Standards Association (IEEE SA) can play a critical role to help drive innovation leading to blockchain use in clinical trials.
The IEEE SA is actively involved in educating and driving adoption of emerging viable (i.e., pragmatic and responsible) applications of cutting-edge technologies such as blockchain/DLTS, artificial intelligence (AI), VR/AR (virtual/augmented reality), sensors, and others into the bio/pharmaceutical value chain. Through consensus development and open collaboration, there has been progress in establishing current technical standards working groups to address the underlying uncertainties in widespread adoption of these technologies. Standards projects such as IEEE P2418.6 (Blockchain for Health/Life Sciences) and P2733 (Standard for Clinical IoTs [Internet of Things] Data and Device Interoperability with Trust, Identity, Privacy, Protection, Safety, Security [TIPPSS]) are creating technical frameworks for interoperability and security of data, an important concern with the application of these technologies in current enterprise architectures.
The IEEE SA Life Science program has a dedicated focus in the bio/pharmaceutical domain to help optimize the development and secure the distribution of medicine using viable applications of technologies such blockchain/DLTs in combination with the IoT, AI, and others that would lead to empowered patients with data consent and enhanced outcomes. Current global incubator and collaboration programs include:
- Technology and Data Harmonization for Complete Remote Clinical Trials: The goal of this multiphase and multiyear program is to develop consensus-driven technical and business workflows incorporating new applications of cutting-edge technologies in combination with existing platforms while redefining clinical operation processes to create patient-driven digitalized clinical trials from study design to endpoint validation with trust, security, and integrity.
- Phase 1: Consensus-driven build of technical and business workflows applicable for remote and site-based studies
- Phase 2: Test assimilating existing trial using new workflows
- Phase 3: If proven true, develop conformity assessment project to certify workflows
- WAMIII (Wearables and Medical IoT Interoperability and Intelligence): Establish trust, privacy, and security for a connected and mobilized clinical device system that features sensors in us, on us, and around us used for remote patient monitoring, drug delivery, and/or diagnosis. There are four main objectives to this program that will be developed utilizing six global test bed sites feeding a wireless global platform development lab. Objectives include:
- Develop global technical standards for the seamless PPAN (personal patient area network experience) both at home and abroad
- Create technical frameworks and standards for clinical grade IoTs for data validation and hardware security and performance
- Close the disconnect among devices, patients, and practice by exploring the use of distributed ledger technologies that enable patient-driven data sharing with security, privacy, and consent
- Explore the use of applying responsible “intelligence” to validated patient sensor data for viable use case applications (i.e., predicting disease, patient recruitment, etc.)
In addition to standards development, IEEE SA has been at the forefront of running balanced and open workshops on the viable use of these technologies and emerging applications in life sciences and health domains. In 2018, IEEE SA held workshops on Blockchain for Clinical Trials, introduced a series of WAMIII workshops that addressed the need for technical frameworks and data standards for wearables and IoMTs for clinical applications to enable sensors to be more proactive in addressing clinical applications. Through these educational and outcome-focused activities, several IEEE technical standards projects were initiated and a multiphase Global Wireless Platform Development Lab was formed that will launch in spring 2020. These activities have helped to cultivate a global group of pharmaceutical professionals, clinicians, technologists, regulators, researchers, analysts, and other stakeholders who are eager to collaborate and develop solutions to the barriers impeding adoption of these technologies.
I encourage those interested in identifying and developing consensus-driven solutions in an open collaborative and diverse community dedicated to enhancing patient care and optimizing clinical trials to get involved in the IEEE SA programs.
About The Author:
Maria Palombini is director of communities and opportunities development in the Life Sciences Practice at the IEEE Standards Association. She currently leads the practice with a mission to cultivate a global group of experts to openly collaborate, evaluate, and drive viable adoption of breakthrough technologies that can enhance the preservation, sustainability, and security of life while optimizing the pharmaceutical and agriculture value chains. In 2017, Palombini joined the IEEE SA to build communities of stakeholders to develop consensus on solutions to drive adoption of technologies such as AI/ML, IoT, VR/AR, and blockchain/DLT in life sciences applications. She holds an MBA, BA, and BS from Rutgers University.