Jean Siebenaler, MD

Articles by Jean Siebenaler, MD

Interventional vs. Non-interventional Study Classification in the EU: Considerations on the Impact of Direct-to-Patient Contacts

ByJean Siebenaler, MD,Sandra Wiederkehr, PhD,Xavier Fournie, MD

October 14th 2016

A new clinical trial regulation in Europe aims to bring about harmonization of European Union (EU) clinical trial multi-country applications. This paper poses a consensual review, fine-tuning, and validation of study classification while further clarifications on this law are sought out.

Considerations on the Impact of Direct-to-Patient Contacts

ByJean Siebenaler, MD,Sandra Wiederkehr, PhD,Xavier Fournie, MD

October 1st 2016

Applied Clinical Trials

Examining interventional vs. non-interventional clinical study classification in the EU.

Latest Updated Articles

Interventional vs. Non-interventional Study Classification in the EU: Considerations on the Impact of Direct-to-Patient Contacts
October 14th 2016
Considerations on the Impact of Direct-to-Patient Contacts
October 1st 2016

Jean Siebenaler, MD

Articles by Jean Siebenaler, MD

Interventional vs. Non-interventional Study Classification in the EU: Considerations on the Impact of Direct-to-Patient Contacts

Considerations on the Impact of Direct-to-Patient Contacts

Latest Updated Articles

Trending on Applied Clinical Trials Online

Building Standardized Evidence for eSource-Enabled Clinical Trials: Multi-Site Validation of a Clinical Research Coordinator Satisfaction Methodology

Bipartisan Bill Would Build Reusable Clinical Trial Networks, With a Focus on Rare Disease

Where the Industry Is Headed as Clinical, Operational, and Real-World Data Connect

ACT Brief: Orchestrated AI Clinical Environments, eSource Coordinator Satisfaction, and Faster Clinical Trials Act

Clinical Trials Do Not Have a Data Problem, They Have a Decision-Readiness Problem