Blockchain in clinical trials, research and data-donation

Clinical trials and research are foundational to medical innovation

Patients themselves are at the center of the research equation; their medical profile and history are aggregated, analyzed, and curated to understand diseases, make new discoveries, and test research hypotheses.

Yet significant barriers exist that inhibit the secure and efficient sharing of patient data:

• Limited accessibility and knowledge of clinical trial (data sharing) opportunities
• Few incentives for patients to share their medical information
• Lack of trust that sensitive medical information will be kept secure
• Lack of digital health record interoperability and ease of aggregating data

The clinical trials research industry (pharmaceutical firms, research institutions, regulators, etc.) has attempted to implement solutions to address several of these issues, but none have fully succeeded. One such promising yet disruptive technology that has the potential to be the game changer needed to solve these issues is blockchain— a unique technology that holds capabilities to radically reshape industries and change the way information is transacted, stored, and shared.

The excitement surrounding blockchain’s potential has predominately been focused on financial services; however, the life sciences and health care industry has the potential to be a new frontier for the technology as a novel solution to securely storing and sharing medical information.

Data donation trends & issues

Industry actors across the spectrum often operate with a shared goal to provide patients access to improved medicine.

Yet, at no other point in history has the patient had more opportunity to shape and influence the health care they receive.

Patients now have unprecedented access to their health data and are actively collecting their own medical information.

This level of access offers tremendous potential. If researchers can harness the data hub that is each singular patient at population scale, then there will be no shortage of medical information that can be analyzed, which could ultimately lead to a more efficient care ecosystem.

Blockchain: The potential game changer

Blockchain provides a way for information to be recorded and shared through a peer-to-peer community.

In this community, each member maintains his or her own copy of the information and all members must validate any updates collectively through a consensus process to validate transactions and events stored in the repository.

Blockchain has evolved from capturing cryptocurrency transactions (e.g., bitcoin) where entries are financial transactions, to a medium that can enable decentralized information sharing and application operations. In this new evolution, information on the blockchain can represent contracts, assets, records, transactions, identities, or practically anything else that can be described in digital form. At its core, blockchain provides a specific set of capabilities: transparency, trust, disintermediation, auditability, and smart contracts.

Due to its capabilities, blockchain may offer a solution to more easily aggregate health data in a secure, trusted, automated, and error-free way. A solution which enforces rules, privacy, and regulations in a mutually agreed upon manner, resulting in a smart-contract between patient and health care stakeholders can be an important enabler to clinical trials and research. This can allow patients to more easily aggregate their data from different sources and share what they choose to with their physicians and researchers. All this puts the patient in the driver seat of health and well-being, rather than being along for the ride.

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Aditya Kudumala Principal, Deloitte Consulting LLP At Deloitte, Aditya is a principal (partner) with Deloitte Consulting LLP, and leads Life Sciences Innovation, Life Sciences AI/Blockchain, and Analytics Hybrid Solutions (Products and Solutions) practices to deliver smarter insights and innovative solutions to drive value for organizations. His primary focus has been in leading and delivering strategy, cognitive/AI, products and technology-enabled transformation initiatives to improve patient outcomes.
Munther Baara Senior Director Development Business Technology, Pfizer LinkedIn Munther is currently the head of clinical paradigm within the global product development (GPD-BT) at Pfizer, spearheading initiatives driving innovation in development operations to align with the paradigm shift in the clinical trials execution model and emerging technologies.
Craig H. Lipset Head Clinical Innovation, Pfizer LinkedIn Craig is head of clinical innovation within global product development at Pfizer, responsible for defining and creating the future of clinical development through digital tools, patient engagement, and novel collaborations.