AI Article Synopsis
- Some new medical inventions and treatments come from research institutions, but there are problems between the people who create them and the regulators that can delay getting these treatments to patients.
- There are barriers in the rules that make it hard for researchers to turn their ideas into actual products or treatments for people.
- The STARS (Strengthening Training of Academia in Regulatory Science) project helps researchers learn about regulations so they can communicate better with the people who make the rules, making it easier to use their discoveries in real medical situations.
Article Abstract
Truly disruptive medicine innovation and new treatment paradigms tend to start in non-commercial research institutions. However, the lack of mutual understanding between medicine developers and regulators when it comes to medicine development significantly delays or even prevents the access of patients to these innovations. Here, we outline what regulatory-related barriers hamper the translational development of novel products or new treatment paradigms initiated in academia, and propose key steps towards improved regulatory dialogue among academia, funding bodies and regulatory authorities. Moreover, we briefly describe how the STARS (Strengthening Training of Academia in Regulatory Science) project aims to reach out to medicine innovators in academia to bridge the regulatory knowledge gap and enhance this dialogue to facilitate the implementation of academic research findings in clinical practice.
Download full-text PDF |
Source |
|---|---|
| http://dx.doi.org/10.1016/j.drudis.2020.10.017 | DOI Listing |
Publication Analysis
Top Keywords
Similar Publications
Want AI Summaries of new PubMed Abstracts delivered to your In-box?
Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!