Boehringer & IBM announce blockchain partnership for clinical trials

The companies plan to explore the use of blockchain in clinical trials in Canada to improve data integrity and transparency



Pharma IQ News
02/18/2019

At the recent Healthcare and Information Management Systems Society meeting, Boehringer Ingelheim and IBM announced their plans to collaborate on the exploration of blockchain in clinical trials within Canada. They aim to discover whether blockchain can increase their data integrity and transparency as trials become more automated.
 
When discussing these plans, Uli Brodl, vice president for medical and regulatory affairs at Boehringer Ingelheim, pointed out that “the clinical trial ecosystem is highly complex as it involves different stakeholders, resulting in limited trust, transparency and process inefficiencies, without true patient empowerment”. It is hoped that blockchain can help address these challenges.
 

How blockchain will be used in clinical trials 

 
Blockchain technology is a secure way to log and record transactions. Once recorded, these “blocks” are then logged to a distributed ledger via a peer to peer network, within a chronological “chain”. This network can be limited to a set number of stakeholders, with each record secure from being tampered with by anyone else within the group. 
 
As Mehdu Benchoufi put it, in the trials journal, “blockchain can have a global impact on clinical research because it allows for [the] tracking, sharing and caring of data”. For those running clinical trials, it is a highly attractive prospect; to maintain granular control of the data while also increasing the ability to share it between stakeholders and then establish a single source of truth. 
 
There are three core problems within clinical trials, which could stand to be improved by the adoption of blockchain technology. These are; conflicting records and difficulty tracking data, challenges in recruiting patients and the lack of reproducibility in many studies.
 
In regards to data, trials often involve multiple centers with different institutional review boards and sources of data. In such circumstances, it can be difficult to manage data and consent and provide a clear record that everyone can access and understand. Good clinical practice also requires as much transparency as possible. Blockchain has the potential to improve this by having a single source point to record, monitor and manage all data records. This will increase collaboration, improve productivity on key processes and offer a secure audit trail.
 
Many trials face problems when it comes to patient recruitment. If blockchain could allow prospective patients to securely store their medical data anonymously, trial recruiters could them reach out to those who qualify. 
 
Lack of reproducibility can also compromise the outcomes of a clinical study and undermine research quality. By using blockchain, trials can have a full record of exactly what happened, when, where and with who. This can increase the ability to reproduce trials effectively.

 

The future of blockchain use in clinical trials

 
In a Deloitte survey, the life sciences industry had one of the most positive responses to the adoption of blockchain within the sector, with clinical trials recognized as a key focus area. 
 
So far, Pfizer, Amgen and Sanofi have actively shown their support for potential applications of the technology, working together to analyze how blockchain could be used in the safe storage of data, to lower drug development costs and to speed up clinical trials.
 
Regulators have also been relatively supportive of the industry exploring blockchain. Both the European Commission and the FDA have been open to new innovations, if the industry can provide examples and cases for review.
 
Currently, more progress has been made with the use of blockchain within temperature controlled logistics, but as this technology develops and solutions are tested and improved, we are likely to see more companies announcing their explorations.