How the Digitization of Clinical Trials can Increase Efficiencies and Reduce Costs
Safe and secure digital identities for all involved stakeholders are key to digitalize clinical trials
The process from discovering a potentially new drug to when it becomes available to patients takes many years, costing an average of 1.3 billion EUR. On top of this, 80% of clinical trials are delayed, meaning there is a significant amount of time and money wasted, particularly in administrative processes. We at Spherity are convinced that by working on digitization and focusing on the patient, the process can be far more efficient and cheaper.
For a clinical study, participants and doctors need to sign paper-based Informed Consent Forms (ICFs), which stay in the hospital. Initially, the sponsor has to create a draft of the ICF template, which has to be approved by the ethics committee. Usually, the sponsor is a pharma company who commissioned the study, whereby the ethics committee is responsible for ensuring that medical experimentation and human subject research are carried out in an ethical manner. The committee has the authority to approve, reject or stop studies or require changes to the study.
For every change in the study, participants must go to the hospital and sign a new ICF. Since clinical trials can run over the years, this produces high administrative costs for clinics and sponsors. Doctors need to countersign the ICF and explain each change to the participant. Sponsors need to document every updated ICF. Without having a valid and up-to-date ICF, the Sponsor cannot conduct any trials and use the results of his research.
80% of clinical trials are delayed
The Problem
Informed Consent is in the Top 10 list of cited regulatory deficiencies, which leads to regulatory sanctions, delays, and litigation. The documentation of studies is currently primarily paper-based, making it hard to account for subsequent retrieval of documents, personnel changes, water damage, fire, etc. It can lead to uncertainties and damage of records resulting in a significant share in costs. Besides that, there are no ICF requirements for each trial, country, and hospital, resulting in complex ICF management processes. Since most of the participants are participating in multiple studies, the documentation work increases dramatically. Likewise, it is crucial that no personal data get leaked during the whole documentation process and that the information provided is reliable.
At present, there is no available, scalable technical solution that addresses the storage, standardization, and subsequent changes of clinical trials in an acceptable way.
Enable Digital Informed Consent Forms in Clinical Trial Studies
In collaboration with the industry we started a proof of concept for this use case in January 2020 which was completed in June 2021. As next step a Minimum Viable Product should be developed by the end of 2021.
The Solution
We are using decentral Digital Technologies to enable an interactive, engaging, and trust-based informed consent experience for patients. In this use case, we use two important new concepts to build up a decentralized trust network for the Informed Consent process: Decentralized identifiers (DIDs) and Verifiable Credentials (VCs).
- Decentralized Identifiers (DIDs) are a new type of identifier for verifiable, decentralized digital identity. DIDs can be used to digitally identify an enterprise, a human, an object, a machine, or data. In this use case, every actor participating gets a digital identity that can be anonymized, is unique, and verifiable for third parties.
- The second new concept is Verifiable Credentials (VC), which are a block of verifiable data attributes cryptographically bound to the owner’s identities, the issuer, and optionally to other parties. A Verifiable Credential may be used for any application where data benefits from being verifiable.
The solution uses blockchain as a trust anchor, ensuring immutability of digital signatures and preventing a single point of failure. By using a combination of Verifiable Credentials and Decentralized Identifiers anchored on a blockchain, we put patients in greater control of their enrollment and journey through clinical trials. Further, we put the sponsor in control of the Informed Consent process documentation and increase speed and compliance through ‘anytime,’ real-time auditing.
Digitalization of Informed Consent Forms for Clinical Studies lowering the total cost by up to 50%
The participants can access the blockchain-based trust anchor using their individual Spherity Cloud Identity Wallets to manage their ICF data. With the Spherity Cloud Identity Wallet identity subjects, credential issuers or verifiers are able to interact with each other in a trusted and verifiable way. Participants and doctors can access their Cloud Identity Wallet to manage ICF signatures through white labeled web applications. Sponsors or the ethics committee can integrate their Cloud Identity Wallet into existing business applications to ensure a seamless process managing ICF. Thus Wallets are the only add-on technology to the existing informed consent process integrated via API easily, which allows actors to sign and revoke ICFs digitally.
Within this Architecture, the Blockchain provides the Anchoring Layer for the Identities of the participating parties according to their roles and responsibilities. The actual document (ICF) is stored off-chain and shared between the Identity Wallets. Solely the DID document is stored on-chain, which contains information associated with the DID. The standard DID document contains a set of cryptographic public keys for verification, a set of auth methods for authentication, a set of endpoints for interaction, a timestamp for audit history and a signature for integrity.
Personal health data: There is a perception that when blockchain solutions are used, personal data is not properly safeguarded. In our solution, no personal health data, hashes or encrypted forms of personal data will ever touch a blockchain. Importantly, the blockchain is only used as a form of public directory for the pharma company and clinic to register digital signatures. These digital signatures will then sign Verifiable Credentials which exist entirely off-ledger.
User Story
The view of the Pharma Company: Each pharma company has access to their Cloud Identity Wallet account to manage their clinical trials and ICFs. As the Cloud Identity Wallet is integrated into existing systems, the user and role management can be linked to the active directory. Authorized employees are able to create a new ICF template and request an approval process at the ethics committee. After getting a new ICF template signed (approved) by the ethics committee, the ICF documents can be shared with respective clinics. After sharing the ICF document, the pharma company has access to all data linked to the shared ICF document without seeing the patient’s personal data. In case an update of an ICF is required, the pharma company can request re-consent from the patients.
The view of the Clinic: Each clinic participating has its own identity wallet account to manage the clinical trials and the digital ICF documents. Further, the clinic has its own role and use management to enable their doctors to sign individual ICFs. The clinic can verify ICF documents shared by the Pharma Company and can use these documents to create individual ICFs that can be signed by each participant. Although the clinic can send ICF to multiple participants at the same time requesting the signature, countersign the signed ICF and finally send all related information of the ICFs to the pharma company without revealing the patient’s personal data.
The view of the Participant: Each participant needs an account with a cloud identity wallet integrated into the web application. After a personal consultation, the participant can sign his ICF using his digital signature stored in their cloud identity wallet. The participant can revoke the consent to the ICF at any time, and the Clinic as well as the Pharma Company immediately get a notification about the update on the ICF.
Example User Journey
The following diagram illustrates an example of a Pharma company issuing an ICF to the patient. We assume here that the study’s sponsor already created an ICF template which the Ethics committee approves.
- First of all, the Pharma company sends the approved and signed ICF template Credential to the Clinic.
- In the second step, the Clinic/Doctor creates a unique participant ICF and sends it to the different patients.
- The participants can then read the ICF document and sign the ICF digitally or withdraw if they do not want to accept the ICF.
- After the participant has signed the ICF, the Clinic countersigns it and submits it (signed by ethics, participant, doctor) to the Pharma company without any Personal sensitive data being shared.
- The Pharma company finally stores the ICF in their wallet.
Client Benefits
- Patients benefit from transparent and efficient ICF processing due to safe and secure digital identities.
- Sponsors, Participants and Doctors don’t have administrative efforts to sign and update ICFs as everything is managed digitally without the need to go to the hospital to sign a new ICF.
- Doctors and participants save time which reduces overhead and cancellation rates in clinical trials.
- This time saving enables physicians to focus on the study without wasting time on paperwork.
Spherity realized a new approach was needed in how we think about the concept of identity in the emerging digital economy — now and into the future.
Benefits of working with Spherity
- Efficiency
Better outcomes of clinical trials resulting from the less amount of time spent on paperwork and low cancelation rates - Compliance
Improve appropriate use & compliance of Informed Consent Forms in clinical trials. - Flexibility
Our cloud-based infrastructure enables flexible set-up, integration and ongoing refinement. - Forward-thinking
We participate actively in the SSI community so that our Decentralized Identifier (DID) and Verifiable Credentials (VC) implementations will remain compliant even as standards are iterated and refined.
How Spherity make digital Informed Consent Forms in Clinical Trial Studies a reality for you?
- Innovative tech
Spherity’s Identity Wallet helps you achieve a higher level of trust and creates opportunities for you to secure ICF exchange for participants and other stakeholders via decentralized Digital Identities. - Experience
You benefit from our vast experience in helping clients build decentralized identity management solutions for various customer journeys across supply chain transparency, risk assessment, audit trails for data analytics and many more use cases. - Knowledge
Our developers and systems designers combine years of deep research in the emerging decentralized identity space with a wide range of cross-industry experience. - Easy Integration
Developers can simply use Spherity’s APIs to easily connect existing systems or applications to Cloud Identity Wallets as a SaaS solution.
If you’re curious about the digitalization journey of Informed Consent powered by digital identity technologies, feel free to reach out to us.
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