Using blockchain to drive patient engagement and reimbursement in clinical trials

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Chris Tyson, CIO

Tue Feb 06 2018 09:00:00 GMT+0000 (Coordinated Universal Time)

This month I outline how novel technology solutions can be applied to improve patient retention in clinical studies via a combination of next-generation patient monitoring and blockchain.

Background On average, the administrative and monitoring costs of a clinical trial can account for as much as 30% of the overall trial expense across phases 2 and 3. Further to this, the patient recruitment and retention costs per site can account for in excess of 12% of the costs of each site (Eisenstein, 2008). Critical success factors in managing and reducing these costs can be attributed to how patients are motivated and communicated with during long running studies. This is very important as patient drop out is both labour intensive for site administrators and costly in terms of the loss of the patient’s data to the study data set. One of the means available to researchers to support the retention of patients is a well thought out patient reimbursement strategy. However, it is very common for reimbursement to be directly linked to attending clinical site visits and has no link to the activities and behaviours patients must engage and adhere to for the other parts of the study protocol outside of the hospital. IOTA and the Tangle The IOTA Foundation is a Berlin-based non-profit corporation, which aims to solve the problem of using cryptocurrency to make micro-payments. Currently, the blockchain-based design of digital tokens such as Bitcoin and Ethereum makes transaction fees necessary, as some participants need to be incentivised to validate transactions. This makes transactions involving very small amounts of cryptocurrency prohibitively expensive, and also introduces problems with scalability and a network bias in favour of high-value transactions. IOTA's Tangle is a novel architecture in cryptocurrency, which eliminates the need for transaction fees and does not favour any type of transaction over any other, thus enabling truly cost-effective micro-payments. This technology does not aim to become a 'currency' akin to Bitcoin in its own right, but rather to serve as the primary vehicle through which automated micro-payments are made. The Problem and the Solution The Declaration of Helsinki considers the issue of informed consent one of the most important components of ethical human clinical trials. It is commonplace for patients to be incentivized for participating in clinical studies, but there is a point raised against the use of financial incentives, arguing that excessive compensation could induce subjects to consent to a study without regard to its risks, thus being unable to give informed consent. As outlined by Breitkopf (2011), however, such monetary incentives provided are not considered, in themselves, to be coercive. In fact, Bentley & Thacker (2004) found that while monetary payments do increase subjects’ willingness to participate, they do not blind them to the risks involved. Cryder et al (2010) found that higher payments lead subjects to learn more about the risks involved, and thus to give more thoroughly informed consent. There are generally two approaches to payment: Wage Payment and the Reimbursement Model (see Ripley, 2011). While the two models have their merits, it is very common for financial incentives to vary significantly within both therapeutic areas and for there to be different incentives in place for the same study but between different sites. Away from the study site, study design also has certain behavior expectations of patients and these are very important as participants in studies will take these into account, thus impacting the levels of compliance with study design. As the industry moves away from antiquated, paper based methods of collecting data and towards new, more reliable mobile technology channels, it is essential to begin to understand how to incentivize individuals to engage with these new data collection mechanisms. As levels of inconvenience are commonly cited as reasons for non-compliance to study design by patients, the use of payments at a more granular level provides a solution to incentivizing patients during long running studies. Further, as some of the new technologies being brought into the space do themselves possess a degree of inconvenience inherent in the technology (i.e. I must wear my wearable in bed as the device needs to collect my sleep data), some form of incentive to ensure continuous use of the technology is needed. One way of increasing levels of compliance is gamification (see Abdul Rahim et al., 2017), which involves designing games around interventions such that compliance earns patients in-game rewards. For example, patients could be awarded a 'Gold Star' or points each time they complete some necessary action. Gamification has proven promising in improving compliance with ongoing treatment, and combined with reimbursement in the form of micro-payments it could be a powerful motivator during studies as well. If a new way of keeping participants engaged with data collection using new technology can be found, it will greatly enhance the overall goals of research organizations regarding the ability to collect higher quality data that can lead to the approval of the therapies being developed. A Strategic Technology Approach Collecting data via promoted engagement with elements such as PROs, Medication Adherence and Wearable/sensor telemetry is ideal for capture and processing within the payments layer of IOTA as they are time critical and can be measured for reward/reimbursement with pre-defined metrics. This would provide a significant enhancement to the Wage Payment model by allowing trial sponsors to set prices and thresholds for reimbursement according to activity levels. Additionally, this may also help to reduce drop-out rates where reasons of inconvenience are given as the reason for a participant to quit a study. The majority of the hypothesis for the engagement with the technology as proposed above, and the subsequent mode of reimbursement via the IOTA platform, is based on the concept that cryptocurrency (and the use of Wallets) is about to become mainstream and thus, this will be something patients will be familiar with. Further to the convenience of utilizing a new mode of money such as cryptocurrency, it has also been found in the research of Ripley (2011) that patients are willing to accept “token” gestures as payment for their participation in trials as opposed to direct payment in fiat currency. This provides a very compelling argument for looking at the crypto space, especially with the ability to handle micro-payments, as the future channel of patient reimbursement as it provides a multi-channeled medium of exchange – accept incentives as cash payments, or redeem the value as a blockchain token for use at a later date. Exploring these options today is a topical and timely opportunity to maximize the reach and impact of clinical trials. References Ripley. E, Macrina. F, Markowitz. M, Gennings. C. (2010). Who’s doing the math? Are we really compensating research participants? Journal of Empirical Research on Human Research Ethics. PP. 57-65. Breitkopf. C, Loza. M, Vincent. K, Moench. T, Stanberry. L. (201 1). Perceptions of reimbursement for clinical trial participation. Journal of Empirical Research on Human Research Ethics. PP. 31-38. Eisenstein. E et al. (2008). Sensible approaches for reducing clinical trial costs. Society for clinical trials. PP. 784. Abdul Rahim. M I et al. (2017). Gamification of Medication Adherence in Epilepsy. Seizure - European Journal of Epilepsy , Volume 52 , PP. 11 - 14. Bentley. J, & Thacker. P. (2004). The influence of risk and monetary payment on the research participation decision making process. Journal of Medical Ethics, 30(3), PP. 293–298. Cryder. C E, London. A J, Volpp. K G, Loewenstein. G. (2010). Informative inducement: Study payment as a signal of risk. Social Science & Medicine, Volume 70, Issue 3, PP. 455-464.

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