Blockchain is considered to be a disruptive technology, and it has already found its use case mainly in finance, education, supply chain, insurance, media, and government. Historically, the Clinical Trials industry is known to be a slow adopter of technology. The clinical research industry in the developed nations is developing 21st-century drugs while using 20th-century technology.
The clinical research industry was adopting the technology in a slow and incremental fashion while other industries adopted new technologies that brought transformational changes in those industries. Even today, the clinical data recordkeeping is largely paper-based or EDC (Electronic Data Capture) is just a digital form of a paper. Those who use EDC systems believe themselves to be technology adopters and innovative. The patient data is still entered manually into the systems and the data that is not entered is considered to be non-existent. The data collection is still a foreign concept. A patient is simply a subject in the whole clinical trial process.
The pandemic has exposed critical gaps and vulnerabilities in the healthcare and clinical research industry and has forced the industry to leverage technologies used in telehealth and telemedicine to minimize disruptions in the clinical trial operations. The advocates of Blockchain technology suggests many use case of Blockchain technology in clinical trials. However, it has failed to generate enough interest in the clinical trials industry.
Blockchain has definitely been recognized as a potentially disruptive technology that can solve the problem of trust and transparency bringing transformational changes in healthcare and clinical trials. The experts who understand blockchain technology and clinical trials suggest that blockchain can help in solving many industry pain points related to informed consent, record keeping, payments, and recruitment. Despite all of these benefits, blockchain technology has been neglected and did not find its place in the priority list of the stakeholders.
Blockchain may not be a magic pill that can solve all the problems and pain points. Blockchain may have built-in accountability but a lot of it depends upon how the security is designed, like any other system. Blockchain may have its own limitations and challenges but it has enormous benefits that increase the trust and transparency in clinical trial data. It turns patients from health consumers to health producers, and give them the ownership of their data. The regulatory agencies benefit greatly from the trust and transparency that makes the underlying data trustworthy. But the important question here is, how do sponsors benefit from blockchain?
A sponsor decides what technologies they need to invest in. Let’s think from a sponsors perspective. What incentive do they have to invest in Blockchain? Their basic aim is to conduct a clinical trial and obtain data to gain approval from the investigative new drug. If they can conduct a trial without making any extra investment in blockchain then there needs to be some other incentive to adopt new technology. Simply because Blockchain is a disruptive technology, it doesn’t offer any immediate benefits to sponsors. Blockchain is a decentralized structure of the backend database structure. The frontend user interface of a blockchain application may not look any different from a non-blockchain application. A sponsor works with many CROs and clinical sites who have their own clinical trial management systems and other peripheral systems which makes it a web of complex systems sharing information with each other. It would be a difficult adventure to bring in new systems that were not tried and tested in similar settings.
Everyone likes to have freedom but it’s another thing whether people exercise that freedom or not. That’s human nature and the executive decision-makers in the life-science industry are humans too. Blockchain records are immutable and timestamped, and any changes made to the data records are traceable. There is no doubt that sponsors make every effort to safeguard the trustworthiness of clinical data and do not indulge in any kind of malpractices, but the possibilities of foul play by a few sponsors with malicious intentions cannot be completely ruled out. There are possibilities of tempering with the data. Psychologically, it is quite possible that sponsors get a feeling of insecurity driven by the fear that everyone is watching now. To some, it may come as a threat to their freedom of altering things for their interests best known to them. Transparency is the foundation of trust, and it is in the interest of the entire industry to be more transparent. Blockchain can help sponsors achieve that goal. Greater transparency opens the doors to more business opportunities. The improvement in brand equity is substantial and long term, and so sponsors have every reason to become more transparent without any fear or doubt.
It may be difficult for Blockchain to find clinical trial sponsors who willingly want to adopt the technology simply because of its features and benefits. The industry would need to take sponsors in confidence and work with them to incentivize the adoption. Regulatory bodies like the FDA can enforce the implementation of blockchain but it may be impractical and counterproductive. However, they can develop and promote such solutions and let the industry choose if they want to adopt. Recently, the FDA has created an open-source app called MyStudies App to be used by sponsors to obtain informed consent remotely during coronavirus pandemic. It is difficult to say how many sponsors would have used that app but it makes sense from sponsors’ perspective to benefit from it instead of investing to develop their own solution. FDA’s branding will give them another reason to trust the technology if they develop another version with a blockchain option. Otherwise, the responsibility then lies on the shoulders of CROs and technology companies to introduce adaptors, accelerators, and plug-ins for specific modules that integrate seamlessly with existing systems. Developing blockchain-based clinical trial management systems may be a huge effort to have a very low chance of successful adoption. There are a few startup companies like Bloqcube who have accepted this challenge to develop blockchain-based clinical trial management systems.
There is an opportunity for small blockchain-based tech startups to develop such adaptors for very specific modules. For example, developing an adaptor for a blockchain-based module to obtain informed consent from the patients. The 21st century is an era of open-source technologies. Companies do not need to re-invent the wheel from scratch. The open-source MyStudies app can be modified to reuse its frontend and have a blockchain backend database. The real challenge may not be in developing such an application, but the implementation of it. Finding the right sponsors and CROs who are genuinely interested to collaborate with tech companies, and willing to invest in finetuning the app by filling the gaps for a smooth adoption.
Blockchain platform vendors such as IBM and Oracle will play a bigger role in blockchain adoption. Both of these big vendors have highlighted possible use cases in the clinical trials. There are many other vendors, small and big, that offer blockchain platforms as a service. Many have programs for startups who want to build their applications. Since these big vendors already have business relationships with sponsors, they are conveniently placed at a sweet spot form where they can easily engage and collaborate with sponsors.
The blockchain adoption by the clinical trials industry is not going to be an easy hill to climb but a coordinated effort by other stakeholders working hand in hand with sponsors in that direction can make things easier. Continuous efforts to educate sponsors about the benefits and engage them in discussions can further provide that extra horsepower required for making the clinical trials industry narrow down the gap with other industries. This is in the larger interest of the whole healthcare and life-sciences community, and every small effort in that direction makes a big difference because the stakes are high.
Disclaimer: The views expressed are the author’s personal views and do not represent the opinion or endorsement of any entity whatsoever with which the author has been, is now or will be affiliated. The author does not accept any responsibility or liability for any direct, indirect, or consequential loss or damage resulting from any such irregularity, inaccuracy, or use of the information.
