Artificial Intelligence (AI) in clinical research: transformation of clinical trials and status quo of regulations

Artificial Intelligence (AI) supported technologies play a crucial role in clinical research: For example, during the COVID-19 pandemic the Biotech Company BenevolentAI found through a machine-learning approach that the kinase inhibitor Baricitinib, commonly used to treat arthritis, could also improve COVID-19 outcomes.

By |2022-06-23T12:07:22+02:00June 23rd, 2022|Categories: 2 Cents on Medicine|Tags: , , , , , , |

EU CTR: How to write a good Lay Summary of clinical study results

Lay summaries are a display of clinical study results intended for study participants and the general public. The aim of a lay summary is not only to enhance understanding of complex medical information, but also to increase transparency in clinical research.

Electronic informed consent (eConsent) in clinical research in Europe: opportunities and bottlenecks

While eConsent has become a reality in the US, Europe is still lagging behind in its implementation. To protect patient rights without compromising on the full potential of clinical research, flexible and dynamic consent formats will be crucial in the future.

Investigator Initiated Trials (IIT)

Can they demonstrate scientific merits and align with corporate objectives? Often initiated by researchers or investigators as a part of an observation, an Investigator Initiated Trial (IIT) or Investigator Sponsored Trial is one of the kind of clinical trials that take up specific questions from clinical care, such as therapy optimization or off-label use, and are usually of no economic interest.

Vom Aussterben bedroht – gefährdet der Brexit klinische Prüfungen in UK?

Aktuell laufen ca. 1.500 klinische Studien in verschiedenen EU Mitgliedsstaaten, deren Sponsoren ihren Sitz in UK haben. Schätzungen zu Folge werden 50 % dieser Studien auch nach dem Austritt Großbritanniens aus der Europäischen Union (BREXIT) am 30. März 2019 weiterlaufen. In diesem Zusammenhang stellt sich unweigerlich die Frage: Wie geht es mit den klinischen Prüfungen und der Zusammenarbeit mit UK nach dem Brexit weiter?

Go to Top