A privately held German drugmaker and one of the world’s largest technology companies plan to work together to integrate blockchain into clinical trials.
The Canadian divisions of Ingelheim am Rhein, Germany-based drugmaker Boehringer Ingelheim and US technology giant IBM said Tuesday they would collaborate to explore blockchain in clinical trials in Canada. The announcement was made at the Healthcare Information and Management Systems Society meeting, currently underway in Orlando, Florida.
The companies said they would test whether blockchain technology can provide a decentralized framework to enable data integrity, provenance, transparency and patient empowerment, along with automation of processes for clinical trials. The aim is to improve quality and patient safety in trials, whose current processes they said are often inadequate, leading to erroneous trial records that threaten safety and interpretability. IBM will provide the blockchain technology.
“The clinical trial ecosystem is highly complex as it involves different stakeholders, resulting in limited trust, transparency and process inefficiencies without true patient empowerment,” said Uli Brödl, vice president for medical and regulatory affairs at BI’s Canadian division. “Patients are at the heart of everything we do, so we are looking into novel solutions to improve patient safety and empowerment.”
A search on the ClinicalTrials.gov database did not turn up any trial pages that mention the word “blockchain.”
Nevertheless, in December, several interviewed executives and experts said that ensuring compliance in clinical trials would be a key application for blockchain technology in the context of pharmaceutical companies. In particular, the idea of a shared, yet secure and incorruptible ledger system that can potentially play a significant role in improving the accuracy of data is attractive to the industry.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
In addition to BI, other drugmakers are exploring the use of blockchain in clinical trials as well, such as France’s Sanofi. The technology, Hashed Health CEO John Bass said in December, could create a “shared source of truth” in trials rather than the current standard of multiple, individual sources of truth. That, in turn, would allow all the actors in a trial to share the same information, including consent and research information, which would also help speed up processes like protocol amendments.
Another executive in the December report, CEO Robert Chu of Embleema, remarked that 2019 would be the year that companies start conducting pilot experiments with blockchain.
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