Blockchain-timestamped protocols could improve the trustworthiness of medical science

According to a peer-reviewed and recently approved paper, blockchain-timestamped protocols could improve the trustworthiness of medical science.

The British authors, Dr. Greg Irvine and Dr. John Holden, provide a proof-of-concept study using a low cost, independently verifiable, blockchain method that could be widely and readily used to audit and confirm scientific studies.

“Outcome switching, data dredging and selective publication are some of the problems that undermine the integrity of published research.”
— – Irvine and Holden

Clinical trials generate large amounts of information, much of which is used by regulators when evaluating a drug for licensing. In the UK, the Science and Technology Committee exists to ensure that Government policy and decision-making are based on good scientific advice and evidence.

“Clinical trials are the experimental foundation on which modern medicine is built,”  states a 2013 report from the Science and Technology Committee, an enquiry cited by Irvine and Holden. “Trials also make a significant contribution to the UK economy and can provide patients with an important means of accessing the most exciting and innovative new treatments, before they reach the market.”

A key focus of the committee’s inquiry was the issue of clinical trial transparency, “We consider that information relating to trials should be shared in a way that is accessible, assessable, intelligible and usable.”

Witnesses to the inquiry broadly supported the notion of greater trial transparency, and pointed out that it would likely bring about a number of benefits; Fulfilment of basic ethical standards, improved patient outcomes, and enhanced scientific knowledge. It was a common view that greater transparency of trial data would engender greater public trust in medical research.

Dr Margaret McCartney, a General Practitioner and medical writer, told the committee that a lack of transparency in the past meant that she could currently "have no faith that patients taking part in clinical trials are not doing themselves harm."

INVOLVE, the national advisory group for public involvement in research, agreed that there needed to be "far greater openness and transparency in the publishing and accessibility of research findings," if the public were to "trust and have confidence" in clinical trials.

The issues, however, are neither local to the UK, or recently identified. Following the Ministerial Summit on Health Research, in 2004, participants called for the World Health Organization to facilitate the establishment of, "a network of international clinical trials registers to ensure a single point of access and the unambiguous identification of trials."

This was further expanded on during the 58th World Health Assembly, in 2005, that called on the global scientific community, international partners, the private sector, civil society, and other relevant stakeholders to: "establish a voluntary platform to link clinical trials registers in order to ensure a single point of access and the unambiguous identification of trials with a view to enhancing access to information by patients, families, patient groups and others."

In response, the International Clinical Trials Registry Platform (ICTRP) was established in 2006. The global initiative aims to make information about all clinical trials involving human beings publicly available.

Six years later, the World Health Organization International standards for clinical trial registries were released. The mission of the WHO International Clinical Trials Registry Platform is to ensure that a complete view of research is accessible to all those involved in health care decision making. “This will improve research transparency and will ultimately strengthen the validity and value of the scientific evidence base.”

Despite the creation of numerous trial registries, Irving and Holden state in their paper,  “problems such as differences between pre-specified and reported outcomes persist.”

“If readers doubt the trustworthiness of scientific research then it is largely valueless to them and those they influence.”
— – Irving and Holden

“The medical research community has been severely damaged by evidence of malpractice,” said Rebecca Lawrence, Managing Director of the F1000 Group, “The blockchain method proposed in this new paper offers a timely and promising solution.”

The proof-of-concept described in the paper used a copy of the clinicaltrials.gov study protocol, which was saved as an unformatted text file. The document’s text was entered into an SHA256 calculator, providing a SHA256 digest. The digest was then converted into a bitcoin private key, and corresponding public key, using a bitcoin wallet called Strongcoin.

A new account was created in Strongcoin and the SHA256 digest used as the account password (private key). Strongcoin then automatically generated a corresponding Advanced Encryption Standard 256 bit public key. An arbitrary amount of bitcoin was then sent to a corresponding bitcoin address.

To verify the existence of the document a second researcher was sent the originally prepared unformatted document. An SHA256 digest was created as previously described, and a corresponding private key and public key generated.

The exact replication of the public key was then used to prove the documents existence in the blockchain. “Incorporating a transaction into the blockchain using a public and private key generated from the SHA256 digest of the trial protocol provided a timestamped record that the protocol was at least as old as the transaction generated.”

The transaction took under five minutes to complete and the process cost was free “as the nominal bitcoin transaction could be retrieved.”

Researchers were able to search for the transaction on the blockchain, confirm the date when the transaction occurred and verify the authenticity of the original protocol by generating identical public and private keys.

“Any changes made to the original document generated different public and private keys indicating that protocol had been altered.”
— – Irving and Holden

Although the proof of concept used a study protocol, “the blockchain would not be confined to the validation of clinical trials,” state the authors. “The approach could be used for a whole range of observational and experimental studies where registries do not currently exist.”

The UK government has repeatedly demonstrated its eagerness to work with cutting-edge private sector fintech companies and academics, to see where it can encourage the sector’s growth.

"We’ve been exploring how the government can use the blockchain as a basis for delivering tomorrow’s services," Rosie Jessop wrote in a government post. Jessop is Head of Security for the Office of the Chief Technology Officer in the Government Digital Service.

The government hosted its first Blockchain Partnership event at the end of April, bringing together industry, academia and government to discuss how blockchain technology can be used for public services.

“It’s important that we’re not insular and that we don’t just have conversations amongst ourselves to discuss how this technology could impact government. In the UK we’re lucky to have some of the best people working on blockchain technology in the world, and we want to take advantage of that.”
— –  Rosie Jessop, Head of Security for the Office of the Chief Technology Officer in the Government Digital Service

The Government Chief Scientific Adviser, Sir Mark Walport, published a landmark report in January,  urging the UK government to start using blockchain technology immediately. “Government should establish trials of distributed ledgers in order to assess the technology’s usability within the public sector,” was one of eight recommendations in Sir Mark’s report.

Following his report, Sir Mark wrote an article in March, further exploring how distributed ledgers can change the way government does business. “My expert group has scoped some potential uses by the UK Government,” he wrote. “The best way to develop a technology is to put it into practice.”

“Applying distributed ledger technologies in the registration and payment processes for government grants and benefits could prevent financial losses through fraud and error and support the most vulnerable citizens through full financial inclusion.”

• Sir Mark Walport, UK Government Chief Scientific Adviser

Following Sir Mark’s suggestion, Minister for the Cabinet Office Matthew Hancock announced that government will begin looking at blockchain technology “as a practical way to improve the efficiency of taxpayer money distributed as grants to agencies and partners for research and innovation.”

“If a government doesn’t keep up with new and innovative technology, it falls behind on the ability to provide services for its citizens. We want to stay at the forefront. I believe as technology becomes part of the fabric of the nation, it must become part of the fabric of government.”
— – The Rt Hon Matt Hancock MP, Minister for the Cabinet

While the UK government has not announced how they are planning to integrate distributed ledger technologies into their infrastructures, it committed £10 million to the Alan Turing Institute in 2015, to investigate digital currencies and distributed ledger technologies, and are currently looking for case studies showing how blockchains can be used in government.