SPARK Educational Forum 2019: Clinical Trial Design

Frank Wagner, Charité Research Organisation

Olaf Bender, Charité Coordination Center for Clinical Studies

Translational projects heavily depend on proper clinical data that ultimately show safety, tolerability and efficacy in patients. This data is usually accumulated in well-designed clinical trials with relevant clinical endpoints to address the objectives of these trials. The challenge is to keep the focus on the entire clinical development while designing initial trials, so that a clinical strategy can become obvious to the regulatory authorities and the investors alike who are critically evaluating the market authorisation.

In this SPARK Educational Forum we will be discussing overall aspects of proper clinical trial design a) from an educational perspective addressing general questions, and b) from a specialized perspective trying to highlight innovative trial designs that have emerged recently and are used to make early clinical trials safer and improve results.

We have invited Prof. Frank Wagner from the Charité Clinical Research Organisation to inform us about recent developments in Phase I/II clinical trials. His focus will be on endpoint selection and the impact of the new EMA-FIH Guideline in this early segment of clinical development. Dr. Olaf Bender from Coordination Center for Clinical Studies (KKS) at Charité is helping teams to prepare and conduct clinical trials (drugs, medical devices etc.). He will tell us about aspects to be considered when planning a trial and how the KKS can support you in the implementation of your study. With the profound knowledge of the speakers, this evening will highlight the vast know-how present at the Charité, and give investigators insights into how best to design their clinical programs.