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:
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:
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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Winner of the 2022 Prix Galien award for digital health, widely regarded as 'pharma's Nobel prize'4
Winner of the 2022 Prix Galien award for digital health, widely regarded as 'pharma's Nobel prize'4