Trust has always been a quintessential aspect of effective communication between stakeholders. With blockchain being an emerging technology overpowering the legacy data management systems of the financial sector, its applications to other sectors such as healthcare have simultaneously become an area of great significance. As such, decentralized data management is now aiming at leveraging one of the fastest growing data sets of our times: healthcare data.
A critical area where such innovation is currently taking form is none other than clinical trials. With drug development costs rising at an estimated 9% per year pharmaceutical giants are in search of new ways of effectively and efficiently managing large sums of data with hopes on increasing data security to ultimately reduce research and development costs. Conglomerates such as Pfizer, Amgen and Sanofi have all started showing interest in potential uses of blockchain technology to reduce such data burdens.
Blockchain stands as a decentralized database framework allowing for transparency between stakeholders. In the drug development pipeline, one such application for this is clinical trials. By having several data nodes, data sets are not owned by a particular individual: rather, each stakeholder has a copy of the data set. Importantly, this enables regulatory bodies (audits), pharmaceutical companies, investigators, sponsors, contract research organizations (CROs), trial sites and critically trial participants to communicate in a manner where trust is instilled in the nature of the algorithm. Ultimately, this allows for the immutability, decentralization and ordered nature (time stamping) of data.
Clinical Trials are used in the healthcare industry to produce large amounts of data to approve new drugs, medical equipment, and treatments for general patient use. During such studies, large amounts of data are collected with regard to drug effects, patient symptoms, drug reactions and several other parameters crucial to the safety and efficacy of new medicines.
In clinical trials, blockchain’s usefulness becomes evident when pertaining to issues of clinical trial reproducibility, data sharing, personal data privacy concerns, and patient enrolment. Exemplifying the data burdens clinical trials face, it was estimated by Ioannidis et al that 80% of studies are non-reproducible as a result of impaired data management. When examining patient enrolment, it has been shown that 86% of trials do not reach their recruitments goals on time, and subsequently 19% of registered trials are terminated as a result of their inability to reach sufficient patient enrolment.
Three key areas of blockchain allow for its advantage over traditional legacy data management systems: time stamping, time ordering and smart contracting. The first, is responsible for the lack of posteriori data reconstruction and as such enhancement of security via proof of data storage. Secondly, the time-ordering aspects of blockchain technology enable the coherent storage of data as a means of ensuring data integrity. The latter, smart-contracting, is a critical edge for blockchain as it facilitates the addition of contractual clauses on the database whereby set actions are carried out in an autonomous process, leading to the security and quality control of data amongst stakeholders.
Another key advantage of blockchain is the way it enables consent before randomization within the clinical trial context. Thus far, the FDA has reported that an estimated 10% of trials they oversea endure severe consent collection related issues. This ranges from “failure to obtain written informed consent, unapproved forms, invalid consent document, failure to re-consent to a revised protocol and missing institutional review board approval to protocol changes or the data themselves (e. g., data from an e-case report form)”. Crucially, through stored proofs whereby patient consent has been provided blockchain based platforms could provide security and clarity to issues pertaining to consent recruitment. This appears even more critical when considering the randomization post patient consent. Randomization is imperative to the validity of trials and smart contract protocols are able to follow clausal procedures to ensure that patient randomization takes place after patient consent has been provided. This allows for the inclusion of metadata, thus broadening the capabilities of statistical analysis as they are inter-related with smart contract protocols.
With respect to data privacy, a decentralized platform can appear at first to be ineffective by virtue of it having multiple replicate copies of the datasets, as opposed to single repositories. To better understand how this applies to blockchain two different types of data need to be addressed. Firstly, metadata could refer to the public elements of a blockchain as exemplified in patient recruitment. Conversely, personal data could be data that is stored on a private blockchain between agreed upon parties. As such, personal data can refer to the consistent monitoring of patients. More importantly, the flexibility of blockchain allows for the interoperability of private and public databases as seen by several hybrid blockchain communication platforms such as Cosmos and Polkadot.
On an even more practical level, the data contained in transactions on the platform cannot be decrypted by all users. Rather, users are able to see intra-blockchain transactions in the same way a person is able to obtain one’s bank address. Fundamentally, this prohibits users from attaching a personal identity to a blockchain address.
Another area of key importance within the clinical trial framework is that of patient enrolment. Current patient enrolment technologies include data scattered over several independent and incompatible proprietary systems. Subsequently, this often leads to insufficient enrolment resulting in impairments to study conclusiveness and as such premature trial termination. On a study published by Achilleas Thoma et al. on “How to optimize patient enrolment” (for clinical trials), it was estimated that out of all the trial patients the study observed, 85% were not aware that there was on ongoing clinical trial whereby they could have benefited from the trials results. To tackle this, smart contracts can be implemented via the interoperability of different blockchain databases to ensure that patients are aware of ongoing trials that could be of interest to them. The matching of patients EMRs (electronic medical records) to current trial enrolment sponsors could greatly improve the efficiency of such recruiting processes.
Similarly, patient enrolment also benefits by being able to deliver parts of the clinical trial to the patients, as opposed to having the patient attend a particular trial setting. With the pandemic acting as a catalyst for finding ways to translate otherwise in person procedures to the virtual world, Pharma is looking for new ways to bring clinical trials to patients, as a means of diversifying trial avenues. A decentralized platform is key to establishing similar scientific results as in a trial with a specific location while also maintaining high levels of data integrity. Whether it is through ePROs (electronically submitted patient reported outcomes) deriving from a patient’s home or through simple trial awareness, certainly blockchain is playing a crucial role in clinical trial accessibility.
On a different level, blockchain technology, although proving promising in terms of disrupting the approach to clinical trials, does have certain barriers it will need to overcome. Firstly, complete data invention is not prohibited by blockchain and as such several backup self-check protocols ought to be placed. Another is issue is finding ways of establishing decentralized platforms with high transaction validity as a means of reducing cost per transaction. Coupled to transactional energy use, time efficiency is also of great importance to such networks. Respectively, platforms need to be able to process transactions fast and for such processes to be scalable for consensus industry adoption. Similarly, equally important are governmental regulations: governments will have to develop regulations and regulatory authorities to oversee these innovative technologies that incorporate tokenization and other forms of digital assets that are not clearly defined or understood by current regulatory authorities.
Looking forward, the adoption of blockchain technology to bioinformatics in the healthcare sector is imminent. Key variables such as increased trust, transparency, and security amongst
stakeholders will certainly prove pivotal to manifesting a change in the way healthcare data is both attained and shared in the future. With the aid of AI and the incorporation of IoT technologies to decentralized databases, platforms in the future could be able to monitor autonomously look out for adverse effects and critical parameters throughout trials. However, how such theory is translated into practice will only be observed through the test of time. Certainly however, reimagining clinical trials through blockchain is proving to be an awe-inspiring approach to tackling some of the biggest data burdens of the healthcare industry.
Great and informative read. It might take some time before blockchain technology takes on within the industry but it’s a possibility, especially if coupled with the recent virtual clinical trial movement it could prove useful for data management and many other aspects