Vision, proper roadmap and delivery for the transformation of the…
Involve your patients in CT from the beginning to ensure their needs are reflected in clinical trials
What are the main objectives today for sponsors to outsource clinical trials?
The main objectives to use the fully outsourced model might differ from sponsor to sponsor, however, added value is always to support access to external networks, to provide access to external knowledge and to increase the sponsor’s resource flexibility in peak pipeline times.
Only by establishing a true partnership with outsourced partners sponsors will be able to use the full potential of this approach, reach their main objectives and turn patient-focused innovations into life-changing treatments.
What are the best approaches to streamline site selection and reduce delays in the recruitment process?
There have been many improvements and new ideas in streamlining site selection and reduce delays in the recruitment process in recent years. The majority of them are data driven and they all depend on using and sharing existing data.
In addition to these there is still an enormous untapped source: Too many patients around the world have never heard about the opportunity to participate in clinical trials let alone have heard the term “clinical trial”. To me this is a communication issue which we might be able to improve together. The outcome might be the “informed patient” who is actively searching for clinical trials.
How has patient centricity been changing clinical trials for good?
Patients are at the core of clinical development and therefore they need to be involved right from the beginning. This ensures patient needs are reflected in clinical trials which makes it much more attractive for patients to participate in clinical trials. As a result this leads to an improved patient recruitment and retention in clinical trials which in turn means we can bring new treatments to patients in need much faster.
Dr. Ekkehard Brockstedt is a Head of Clinical Development & Operations FOT at Boehringer Ingelheim. Ekkehard is a clinical research professional with more than 20 years of experience in drug development from phase II-IV with a focus on biologics.
He has led the conduct of global clinical trial programs notably in inflammatory diseases and cardio-metabolic diseases.
His main focus is on making external collaborations work better and he believes one of the most important relationships to manage in clinical research is the one with an outsourced partner.
Before joining Boehringer Ingelheim Ekkehard held project leader positions in clinical research and R&D project management at PRA Health Sciences Inc., Sankyo Pharma GmbH and Schering AG. Ekkehard received an MSc in chemistry, a PhD in biochemistry and an MBA in management.