This article was written by Dr Melek Somai and Professor James Barlow

In November, Imperial College Business School and the Centre for Cryptocurreny Research and Engineering hosted the first edition of the Hackathon series on ‘Blockchain and Distributed Ledger Technologies (DLTs) in Healthcare and Life Sciences’. The theme of this first edition was the use of blockchain and DLTs in improving clinical trials of new drugs.

The event was organized by the Centre for Cryptocurrency Research and Engineering at Imperial College London and co-sponsored by EIT Health, Microsoft and a VC fund.

Speakers at the event included:

  • Sarah Wilkinson: CEO, NHS Digital
  • Rebecca Pope: Senior Data Scientist, KPMG (Healthcare & Life Sciences)
  • Caroline Rivett: Global Co-Leader for Cyber Security & Privacy in Life Sciences, KPMG
  • James Kinross: Senior Lecturer in Colorectal Surgery, Imperial College London
  • Peter van Liesdonk: Security Engineer & Cryptographer, Philips Research
  • John Bass: CEO, Hashed Health
  • Claudia Pagliari: Programme Director, MSc in Global eHealth at the University of Edinburgh
  • Robert Learney: Lead Technologist – Blockchain and Distributed Ledger Technology, Digital Catapult
  • Katharina Ladewig: Director, EIT Health (UK-Ireland)

The challenge: the current state of clinical trials

Randomised clinical trials (RCTs) are the backbone of the pharmaceutical research and development industry. They are considered the gold standard and represent the most important vehicle by which new therapies, including drugs and some medical devices, are evaluated for effectiveness (benefits) and safety (risks) before being delivered to patients.

However, the design and operational organisation of clinical trials are increasingly convoluted and a bottleneck for innovation in healthcare and life sciences. The planning and execution of a typical RCT costs millions of pounds and takes years to complete. This can hamper the timely release of potentially effective therapies to the patients who are most in need.

Moreover, despite the increasing expenditure on the development of clinical trials, the number of new drugs and other medical treatments approved is declining. The success rate of a drug from the first phase of a clinical trial to approval is around 9.6 per cent, with new innovative therapies hitting a low of 6.2 per cent. In the case of Alzheimer and dementia research, clinical trials over the last two decades have almost all failed.

It also goes without saying that clinical trials are only effective in supporting medical practice if they are published. Recent research on large RCTs suggests 29 per cent of studies were not published and the results in public clinical trial registries such as ClinicalTrials.gov were limited at best. This has raised concerns among the scientific community that the current model of clinical trials is excessively complex, expensive, inadequate and opaque.

The Institute of Medicine in its report Envisioning a Transformed Clinical Trials Enterprise in the United States recognised that “we have limited ability to generate timely and practical evidence” and that a transformation of clinical trials is needed to move forwards.

The tool: blockchain and distributed ledger technology

In recent years, blockchain and distributed ledger technologies have gained increased attention in healthcare. DLTs are the foundation of the new digital economy, primarily for cryptocurrencies such as Bitcoin and Ethereum. They have been seen as the catalyst of the next digital transformation in healthcare and life sciences. Proponents promise to revolutionise healthcare by using blockchain to enable interoperability at the architectural layer, and to replace third-parties and middlemen in the technology research and development process by using distributed, untampered and transparent software.

While this represents a promising (r)evolution, the benefits of DLTs in healthcare and life sciences aren’t yet proven at scale. Currently, most development is focused on the technological aspects of DLTs (i.e. consensus mechanisms, cryptography) and its financial and economic models (e.g. the financial benefit and market for cryptocurrencies). There is a dearth of proof-of-concept projects relating to healthcare.

The hackathon

Over two days, students, engineers and entrepreneurs from Imperial College London and elsewhere worked on prototypes and business cases for blockchain and DLTs to increase the efficiency and transparency of clinical trials.

The main highlights of hackathon were:

Eliminating the middle-men in clinical trials, namely drug industry ‘contract research organisations’ (CROs): During the hackathon, all the ideas revolved around replacing CRO operations by using blockchain technology. CROs are private organisations that act as outsourcing agencies to pharmaceutical companies. In the last decade, CROs have expanded both their market share and scope to include all tasks involved in conducting the different phases of a clinical trial. Today, CROs account for 25 per cent of total spending in clinical trials, with an estimated market of $25 billion in 2013. The two hackathon finalists proposed using DLT to operate all the transactions necessary between the pharmaceutical companies (the sponsor) and the clinical trial sites using blockchain. One group used Ethereum Enterprise on Microsoft Azure to create a distributed decentralised clinical trial protocol using ‘smart contracts’ (see figure below).

Hackathon diagram

Value-distribution to patient: This is perhaps the most powerful insight from the hackathon. Almost all projects and participants devised fairer financial mechanisms for the sponsors, for clinical trial sites, and most importantly for the research subjects (patients), using blockchain as a shared pool of resources and a source of ‘truth’ for all clinical transactions. A group of hackers proposed a model in which the clinical trial sites and the patient enrolled for a given trial received an incremental micropayment using ‘tokens’ when required steps for a study were validated and shared on the blockchain. Each ‘validated’ transaction was associated with the release of a specific number of tokens (which could have a monetary value) to the entities involved in the transaction, including the patient.  Most students did not address the risk of coercion and undue inducement that are related to such incentive models, but all judges agreed this offered a promising approach to increase enrolment and completion of a trial.

Winners

The winning team, Smart Trials, developed a proof-of-concept using Microsoft Azure Ethereum Enterprise to run a decentralised multiparty clinical study. The model was based on translating a clinical trial protocol to a series of ‘smart contracts’ that regulated the collection of data, the management of consent forms, and the payment of fees for activities associated with the study.

The winners were awarded access to EIT Health’s Accelerator Programme and its network of more than 180 partners in Europe.

Judges

We are very grateful to our partners and colleagues who kindly attended the event:

  • Rebecca Pope – KPMG
  • Robert Learney – Digital Catapult
  • Peter van Liesdonk – Philips Research
  • Katharina Ludewig – EIT Health
  • Aman Kohli – Microsoft
  • Bunmi Durowoju – Microsoft

Do you want to get involved?

The Imperial College Centre for Cryptocurrency Research and Engineering was founded in 2014 with the goal of focusing research efforts into blockchain and distributed ledger technology at Imperial College London, and training up the next generation of developers, scientists and entrepreneurs in this new area.

Imperial College Business School’s Centre for Health Economics & Policy Innovation is built around a distinctive programme of research and teaching on health economics, policy and management. Melek Somai is currently a Visiting Research Fellow and is collaborating with Professor James Barlow on research on aspects of innovation in healthcare systems.

Please feel free to contact us: m.somai@imperial.ac.uk

Or visit our website.