Utilizing Emerging Technology to improve Patient Data in Clinical Trials Immuto Follow Apr 1 · 3 min read

Current State of Clinical Trials:

In 2020 groundbreaking discoveries and innovations are being made everyday. If you miss a few days of news it can seem like you’ve fallen significantly behind. While many industries are moving at a sprint, innovation in clinical trials has been at a snail’s pace. This is not to say that the medical discoveries have not been progressing, but, the manner in which these discoveries take place have been slow to innovate.

If a drug is to make it to market the average approval process can take upwards of 12 years. From decades old regulations, pen and paper based processes and intricate processes there are significant hurdles along with drug effectiveness to achieve approval.

Trial Data Management Challenges

One challenge for trials that has evolved over time is data management. Previously, all data for trials were recorded using pen and paper. While for some trials this methodology still holds true, many trials are exploring the usage of digital tools for Electronic Data Capture (EDC), Clinical Trial Management Systems (CTMS), and Case Report Forms (CRF). Using these tools does allow for better organization and tracking of data, but it does come with some flaws.

Digital records are stored in centralized repositories that give certain individuals “super user” controls. Most of the time this isn’t an issue, but in certain circumstances this can lead to data being deleted, altered, or omitted from reporting. Issues with compliance, like these, can have significant consequences on a trial. A prominent example of this is when Australian researcher Bruce Murdoch forged patient consent documents for patients; one of which had passed away years prior.¹

Seeing that this is a high impact problem, it inspired us to focus on developing a solution to help combat this. From our previous experience working at a large pharmaceutical company we saw how blockchain, with its permanent data storage and privacy properties could be an excellent technology to use for protecting clinical data. However, it was also during this time that we realized that due to the technology’s complexity and integration challenges it would be difficult for it to be widely adopted.

Our Solution:

Wanting to solve these challenges to make blockchain accessible to the Life Sciences is what inspired us to found Immuto. Immuto provides an API which allows companies to integrate our service into their existing clinical trial data management software. By utilizing Immuto, we give companies the ability to increase their data’s integrity and audibility, with blockchain-based verification.

By doing this it proves that their data was entered and created in a certain state. From this, clinics, CROs, and Sponsors are able to prove to regulators and outside auditors that their trials were compliant and that their results were reported accurately. All of this is made possible without changing how users utilize their existing EDC, CTMS, eCRF, and Life Science software.

Unlike existing solutions where users with certain privileges can change data without a trace, all data entered is logged by a permanent transaction record.

[A few] Targeted Use cases:

Patient Consent

Lab Data Verification

Learn More:

Immuto Website: www.immuto.io

GitHub: www.github.com/immuto-inc

Email us: inquiries@immuto.io

Source: https://www.washingtonpost.com/news/speaking-of-science/wp/2016/04/01/when-scientists-lie-about-their-research-should-they-go-to-jail/ ¹