Summary: Risklick has launched Protocol AI, an AI-based solution to streamline clinical trial development for medical devices. By using NLP and ML to analyze existing data and auto-generate trial protocols, Protocol AI can reduce the time and cost of clinical investigations. This innovation may give patients quicker, more affordable access to new treatments.
Key Takeaways:
- Protocol AI’s automated approach to designing clinical trial protocols promises to halve document development time, benefiting both medical device manufacturers and patients.
- By leveraging NLP and ML, Protocol AI addresses the relative lack of standardization in the medical device sector and helps improve overall trial quality and success rates.
Risklick, a spin-off from the University of Bern in Switzerland, has launched Protocol AI for medical devices. Protocol AI uses artificial intelligence to accelerate the development of clinical trials while reducing associated costs and risks.
Accelerated Access to New Treatments
This accelerated timeline could grant patients quicker access to new treatments—potentially at a lower cost.
Bringing a medical device to market typically takes 3 to 7 years, according to Risklick, with clinical investigations being the most time-consuming and costly phase. Every clinical trial begins with the development of a protocol, which serves as the cornerstone of the study and determines the trial’s success or failure. Developing a protocol requires an average of six months of intensive work, where even minor errors can result in serious consequences for the clinical trial.
Compared to the pharmaceutical industry, the medical device sector has less standardization and has less clinical trial experience, coupled with growing regulatory demands that make clinical trial protocol development even more complex. These challenges can affect the availability, cost, and success rates of new devices, ultimately influencing patients’ access to innovative solutions.
Risklick developed Protocol AI to address these challenges.
“We have developed a pioneering solution that reduces both the development time and costs of clinical trials, making it easier for patients to access new treatments,” said Poorya Amini, founder and CEO of Risklick. “Our solution has already demonstrated a 50% reduction in study document development time for medicinal products, and we expect similar savings for medical devices with our tailored solution. Our innovative technology has the potential to improve the lives of millions of patients worldwide.”
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Leveraging NLP and ML
Protocol AI utilizes Natural Language Processing (NLP) and Machine Learning (ML) technologies to analyze existing clinical data, publications, and regulatory documents in order to optimize study design. Protocol AI enables evidence-based decision-making and the automatic drafting of clinical trial protocols within minutes, utilizing Large Language Models (LLM). This provides experts with vital parameters for medical devices, according to the company.
As a result, Protocol AI can allow experts to reduce the development time of protocols while aiming to ensure quality and increase the chances of success for the clinical trial.