Fifteen years ago, the British computer engineer Michael Smith and his longtime collaborator, the world-famous child psychiatrist Robert Goodman, digitized two psychiatric tests and made them available online, free of charge.
Doctors around the world began using these tests in their private practices or as part of research studies, with the raw data stored and cataloged on servers controlled by Smith.
Once the data was recorded, Smith had the power to decide how to handle it. A self-described "fanatic" of data has chosen to preserve the original records of each survey, although he knew that others in his position could instead choose to overwrite aberrant data to eliminate statistical noise.
"Smoothing data, as many would call it, is unfortunately quite a common thing," said Smith MedPage Today . "People for various reasons – not [necessarily] unfortunate reasons – can process the data, make it more fluid, to make it look better, in a way, it's a lie from the data point of view."
Because Smith and Goodman alone controlled the servers, it was not long before one of his competitors accused them of tampering with patient data after they were registered. Smith, who refused to name his accuser, called the statement "absurd".
To prove his innocence, he turned to an elegant new technology called blockchain. Smith closed for 18 months, meticulously planning more iterations than a so-called blockchain system. Blockchain is the name for the technology that supports digital "cryptocurrencies" like Bitcoin, but has a much wider range of actual and potential uses.
When he finally unfolded his system, his critics "withdrew the complaint and left." said Smith. "He solved everything, he solved the problem."
Like most people, Smith became aware of the blockchain as the backbone of Bitcoin, but soon realized his potential as a health and medical data administrator. Blockchain offers an unprecedented ability to control everything that happens within a network. Once a transaction is registered, it can not be altered or illegally discarded.
"What you have, in fact, is something like the black box recorder of an airplane in every piece of software," Smith said. Like a black box recorder, the blockchain allows auditors to rebuild exactly what happened inside a car, and when.
Now, anyone Smith invites you to monitor his database has a unique window in the flow of information through his servers. But the window is translucent rather than completely transparent; reveals each data point with date and time without revealing the patient data below.
Within a blockchain system, identical copies of the same database are interconnected between multiple computers and all transactions are grouped into records with timestamps called "blocks". Any change to a database will be reflected across the network, making it almost impossible to tamper with the data.
Blockchain is also very secure, encrypting the information so that it is only revealed to the intended recipient. Furthermore, users are identified by numbers, not names, so the system also maintains the privacy of every individual.
Smith would like to see his model of personalized blockchain or a similar one, applied to clinical research, "where temptation is very good for altering results," he said.
And it is not alone. A 2017 IBM survey found that about 16% of healthcare leaders planned to start experimenting with blockchain by the end of the year and BIS Research said the global blockchain solutions market will reach $ 5.61 billion by 2025.
of the blockchain clamor focused on repairing the nodular mess of electronic medical records. But clinical research is another promising application, with leading computer scientists, health managers and regulatory agencies convinced that this technology will transform the business of human experimentation, not only by reducing the burden but by accelerating the development time of drugs.
Giants Pfizer, Amgen and Sanofi collaborated to pilot a blockchain-enabled clinical research platform. Their goal is to reduce research and development costs by improving the way data is stored and shared between search sites and potentially automating some aspects of research.
And the FDA – which sets the basic rules for clinical research – has worked with IBM to explore how the blockchain could be used to democratize medical records, giving patients direct control over their health records and unlocking those data for research purposes. The goal, according to an FDA spokesperson, is to create "a scalable data exchange ecosystem that supports high-quality research while safeguarding patient-sensitive data breaches."
The use of blockchain in clinical research is converging around three major trends, said Michelle Longmire, CEO of Medable, a clinical research and technology company. The first application is to prevent data tampering and to improve the reproducibility of the research. The second is the use of blockchain to promote data sharing between institutions that otherwise have little incentive to share. And the third is to give patients direct control over the data collected on them in a clinical trial.
Blockchain is particularly suited to these applications because of its "ability to negotiate the tension between data privacy and data sharing," said Maria Palombini, who helps establish global standards for emerging technologies as part of the his work at the Institute of Electrical and Electronics Engineers, better known by the IEEE acronym.
But it is the early days for blockchain, with Palombini noting that it will probably take years, even decades, before large-scale clinical research programs are conducted using technology. He compared today's blockchain ecosystem with the dawn of the Internet – early users can see its potential, but the future is still difficult to predict
As with all new technologies, "there will be little progress and people will fail along
Blockchain can not prevent human error, like a doctor who erroneously notes the blood pressure, but a blockchain-enabled clinical research system could go one long way to prevent errors and deception after data logging.
In theory, here's how a clinical trial with blockchain works: first, a group of research centers, hospitals, life sciences societies and their organizations of contract research would come together to form the "nodes" of a test network.Each of them would have voluntarily the server space and all the data collected and stored would be rated simultaneously through the network.
Observers can see each data point with date and time but not the patient data below.
During the test, each component – from informed consent to the dissemination of the results – would be managed with "smart contracts" or software designed in such a way that the completion of each phase will unlock the next one, like a chain reaction.
Smart Contracts are a perfect technological solution to help you automatically perform the steps of a study protocol, which is a detailed document describing the design of the study, explains Mehdi Benchoufi, MD, an assistant professor of epidemiology at the University. ; Ospedale de Dieu and the Paris University Descartes, and a blockchain expert.
"It is impossible to cheat without anyone being a witness," said Benchoufi. Today, for example, a pharmaceutical company could promise to publish results at the end of an experiment, but later decide to keep these results secret. With smart contracts, blockchain could prevent this obfuscation because the completion of an event (for example the results count) automatically unlocks the next one (publication of the results online).
Better yet, during a study, patients may be able to control the same progress of a process by using an online portal or a mobile app, giving them more control over the personal data collected in the course a study. In the end, "data becomes licensed by biopharma … and they [the patients] get profits from that license," said Longmire, who is working to create a clinical trial network for multiple sclerosis that would work with a model of granting of personal data.  This is the vision. Today the sector is still very much in beta-testing and there are no rigid rules that regulate the way in which blockchain research is to be designed.
Several people have different ideas about how this system should work. Some, such as Benchoufi, argue that research should be conducted on an "open" network, modeled on Bitcoin, while others argue that researchers should use an "authorized" network, in which each member must be allowed to join. Smith's blockchain system, now in its third iteration called ChainZY, functions as a private and authorized network, although it can be configured to function publicly.
The next step is for all these groups to come together and agree on a set of rules – a process led by the Palombini team at the IEEE standards group.
"They can go from 8 to 12 months before a standard becomes a reality," said Palombini. "When we get into the real pilot, it's when they play real patient data, so you have to justify the big cost, which is a partial implementation."
Ultimately, the pharmaceutical industry will have to lead the blockchain revolution in research because it is the only group with the resources to do so, said Lucila Ohno-Machado, MD, PhD, chair of the department of biomedical computing of San Diego Health.
"The other [groups] can talk about it" Ohno-Machado said. "Regulators and sponsors are those who can make a change."
One of the most abstract benefits of the distribution of blockchain in clinical research is that it could improve public trust in clinical research
This idea was popularized by one proof-of-concept study of 2016 in F1000Research "How blockchain-timestamped protocols could improve the reliability of medical science", which was trumpeted by The Economist and FierceBiotech as a project for clinical research in the future.
But the paper sparked heated debate about potential flaws in the author's methodology, and was soon withdrawn.
The whiplash is perhaps the symbol of the strongly debated potential of the blockchain.
Academics such as Benchoufi are fully convinced that blockchain can improve public research trust. With the blockchain, even industry-funded studies would be deemed reliable and the reproducibility crisis would be solved,
And for the pharmaceutical sector, improving confidence is not just an abstract benefit – it could have a significant impact on the line background of any research program, with about a third of the study budgets dedicated to research and patient recruitment.
"This is the clamor of the blockchain," said Palombini. "Whenever you have a trust problem, Boom. Blockchain."
But Cindy Geoghegan, lawyer and principal patient of Patient and Partners LLC, does not buy it. The average person does not associate the blockchain with greater reliability, he said. For Geoghegan, patients will not trust blockchain as a new research tool unless they see a direct and tangible advantage.
"It will not happen from one day to the next," said Michel Goossens, manager of the research company on pharmaceutical contracts ICON. But he said the blockchain could eventually lead to a "paradigm" shift in which people expect their digital data – including health data – to be easily accessible, private and secure.
Bitcoin, the cryptocurrency that made blockchain famous, is a strong example that this cultural change is possible, Goossens said. In the last ten years, Bitcoin has changed the way people think about currency markets by removing the imperative of trusting a central bank.
Ultimately, patients will stop asking whether they trust or dislike the pharmaceutical industry – or even trust their doctor – – rather confident in a larger and more secure data management system, Goossens predicts.
"I think it's definitely a revolution," he said, "but I think the change will be much slower than you think."
2018-08-12T12: 00: 00-0400  Source link