Author: Dennis Velasquez | VP, Commercial, DCT

Decentralization, hybrid?

Those approaches in clinical trials are here to help and should be an aid to your activities rather than a burdensome process. I would highly recommend using technologies that are flexible, and flexibility goes hand in hand with the following:‍

• Patient centricity
• Removing the clinician's burden
• Achieving high levels of patient diversity‍

If the technology you are using and the team of experts implementing it don’t allow you the flexibility of running either a fully decentralised or a hybrid trial, it is probably not the best solution, furthermore, decentralisation shouldn’t mean that you must spend more money. Allow me to illustrate with an example: iPads for sites, iPads add cost to the sponsors, the burden on the CRO to manage the logistics, and the burden to the investigators that will have another device to enter data in, among others, the platform should allow you to communicate between different devices and achieve the best level of communication between the patients, sponsors, CRO, and investigators so you can collect the best quality data and be 100% aligned with regulations.

While I think the decision to have a decentralised or hybrid trial is determined by a correlation between the therapeutic area and the current technology tools available, to build the perfect decentralized clinical trial, several key elements are needed, the following is what I personally believe are the main 10:‍

1. A secure, decentralized platform for data storage and sharing.
2. A robust system for patient consent and data privacy, to ensure compliance with regulations, such as HIPAA, 21 CFR part 11, 50 etc.
3. A way to ensure the integrity of the trial data, such as using cryptography.
4. A way to ensure the quality of the data collected from participants, such as the ability for continuous monitoring and fast actionable mid-study changes.
5. A way to ensure the comparability of the trial data, such as using a common data model.
6. A way to ensure the accessibility of the trial data, such as using an SDK (Software Development Kit), an API-based platform or a combination approach.
7. A way to ensure the scalability of the trial, such as using a cloud-based infrastructure.
8. A way to ensure that the trial is run in compliance with regulatory requirements, such as using a secure, decentralized platform for trial management.
9. A way to ensure effective communication and collaboration among all stakeholders.
10. A way to ensure that the reusability of a questionnaire for example will not involve building from scratch, which turns into added cost and a waste of valuable time

‍Meet me at #scope2023 to discuss further and find out how we at Huma can solve those challenges.

#clinicaltrials #dct #hybridtrials #ecoa #econsent #telehealth #connecteddevices

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