Topic: How Tech Is Revitalizing the Medical Product Approval Process
It took less than a year for coronavirus vaccines to go from experimentation to people’s arms. Compare that to the decade or so it typically takes to get a new drug or medical device evaluated, approved, and released to the public.
Why does the process normally take so long? It takes time to recruit volunteers for clinical trials, conduct the trials, analyze the data, file the appropriate paperwork, and get regulatory approval. In the case of the COVID-19 vaccines, all the steps were greatly accelerated.
What if there is a way to generally speed up the clinical trial process and make it more efficient? Some groups—including IEEE, pharmaceutical companies, and regulatory agencies—say the solution is to use artificial intelligence, blockchain, cloud-based platforms, health-monitoring devices, and other technologies.
The technologies could be used to help conduct clinical trials using telehealth and similar processes. Sometimes called remote or patient-centric trials, such “decentralized” clinical trials could streamline the approval process and reduce the time burden on participants.
In September 2019 the IEEE Standards Association (IEEE SA) initiated the Technology and Data Harmonization for Enabling Decentralized Clinical Trials (DCT) Industry Connections Program.
Through that incubator, activities are in the works, such as new technology and data standards; a testing and training laboratory; a certified technical workflow for the trusted and validated use of remote digital health technologies; and the use of artificial intelligence, blockchain, and distributed ledger technologies designed to increase participant efficacy and safety while accelerating trial operations.
Walter De Brouwer, chair of the IEEE SA DCT Industry Connections Program overseeing the project, says decentralized clinical trials are still an emerging industry and “a bit of a Wild West.”
Topic Discussed: How Tech Is Revitalizing the Medical Product Approval Process