PRNewswire reported that privately-held German pharmaceutical company Boehringer Ingelheim Canada was partnering with IBM Canada to explore the use of blockchain-enabled clinical trials. Apparently, the deal was driven out of Boehringer Ingelheim Canada. This would be the first time that blockchain technology would be used to support clinical trials operations in Canada. It is not a secret that large commercial sponsors struggle with their clinical trials operational systems. Their core designs occurred almost two decades ago now when their customers were far more vertically integrated and well before a massive CRO outsourcing wave. How have things changed! Key systems are used to manage clinical trials and they include the following:
- Clinical Trial Management Systems (CTMS): manage the plans, activities, contacts and trial milestones
- Electronic Data Capture (EDC): provided to external sites to capture trial specific data from investigators
- Integrated Response Technology (IRT): used to randomize patients and supplies
- Electronic Trial Master File (eTMF): maintain all trial-specific artifacts (records) & Collaborative Portals
- Adverse Event & Safety Systems (SAE): track and report on adverse events
Other systems are involved as well. As mentioned, many of these systems are antiquated; legacy architectures from just a handful of vendors who combat each other for market share. A few new cloud-based vendors have made a lot of noise but in some cases their architectures were designed by the same subject matter experts that designed the legacy systems! So even in the case of new cloud-based enterprise apps adoption may only compound legacy problems as they don’t enable the process transformation and liberation of assets and innovative energies as marketed. Essentially the industry is stuck in many ways with enterprise technology that is mediocre at best. Enter forward thinking Boehringer Ingelheim. Factoring in the reality of often erroneous or incomplete records they seek to pilot new processes and the underlying blockchain to ultimately improve trial quality and patient safety—all with the hopes of reducing cost.
IBM Canada and Boehringer Ingelheim Canada Ltd. Aim to determine whether blockchain technology in clinical trials provides a decentralized framework that enables data integrity, provenance, transparency and patient empowerment. If that wasn’t a big enough home run, they also seek to automate and streamline processes with the goal of improved patient safety at reduced cost. Dr. Uli Brödl, Vice President, Medical and Regulatory Affairs, Boehringer Ingelheim (Canada) Ltd. Noted “The clinical trial ecosystem is highly complex as it involves different stakeholders, resulting in limited trust, transparency and process inefficiencies without true patient empowerment. Patients are at the heart of everything we do, so we are looking into novel solutions to improve patient safety and empowerment.”
TrialSite News applauds the intent behind this announcement. We do have substantial experience and involvement with the implementation of large clinical systems in tier-1 global sponsors. They have several challenges constraining their ability to truly innovate operationally. First and foremost, there exists a conservative, risk adverse culture in many of these companies. As pressures mount for efficiencies due to formidable factors from competition to payer pressures, the culture becomes even more “sensitive” and “political.” Second, they are run by internal IT/Quality groups who have turned quality assurance into something very different than intended. When everything is considered a risk how can a risk-based approach even work? There doesn’t seem to be a natural correlation between number of IT and quality personnel and quality IT systems. Third, their division or labor; organizational structure and operating models may be at odds with the process innovations truly needed to progress the organization—put simply: the way they organize themselves may have helped them at one point but presently may represent a hinderance; fourth those that they put in charge may have built a name for themselves in past successful initiatives (e.g. an approved blockbuster) but that doesn’t necessarily translate to the credentials or the background required today for such a prominent role or position and finally, there is often a considerable gap between executive vision, managerial operational pragmatism and rank and file pressures.
Boehringer Ingelheim may have a few things going for it. They are routinely touted as a well-run organization. They have been forwarding thinkers in many cases that this author is aware of. They do have a successful track record, in some cases, in making bets on new technology deployments. Moreover, they are privately-held and do not face the same scrutiny that most of their publicly traded peers face when it comes to external shareholder pressure.
Blockchain is not a panacea. There are material obstacles raised by many smart industry observers. Deloitte identifies elements that must improve for Blockchain to be commercially viable including 1) performance improvements 2) developed interoperability standards 3) reduced IT complexity & cost (blockchain utilizes a lot of electricity); 4) improved regulation and 5) more pervasive industry collaboration. Blockchain deployment in the conservative pharmaceutical industry will face other challenges but they can essentially be segmented into three (3) categories including 1) Organizational 2) Economic and 3) Technological. Organizational challenges include: network governance, network adoption, lack of talent and regulatory concerns. Economic factors include costs of new IT implementations and integration not to mention migration of sensitive, GxP compliant structured and unstructured content and finally quantification of Return on Investment (ROI). Technological challenges include maturity, performance, interoperability, privacy, manageability, ease of integration and supportability.
The jury is still out on blockchain as an enterprise technology platform. TrialSite News will monitor the Boehringer Ingelheim Canada and IBM blockchain initiative. It represents a potentially fascinating one if they can produce something that has material impact.