Hottest information about 11th Annual Optimizing Clinical Trials Summit

10 July 2017


VP Clinical Development, Medical Affairs

3 Questions for Francois-Xavier Frapaise

Why don’t more people enroll for clinical trials?

There is this old fear of being treated as “guinea pigs”. In many countries (western EU), patients have access to new compounds, even if they are very expensive, so the incentive to enrol in clinical trials is limited.

How to make an understandable and convincing protocol for stakeholders?

One way is to engage early with Patients Advocacy Groups and organize Patients Advisory Boards to assess whether the trial is acceptable to patients, ensure they understand the constraints, and fully understand the Informed Consent. In countries where literacy is limited, there is an increased use of video explaining the trial, its objectives and constraints.

How do you implement “patient-centricity“ into clinical trials?

Engage early dialogue with Patients Organization, schedule Patient Advisory Boards

Francois-Xavier Frapaise 35 years of international pharmaceutical industry experience including senior/C-level Positions (CEO, VP Medical Affairs and R&D, CSO, and CMO) in Drug Development, Pharmacovigilance, Medical Affairs and Strategic Marketing/Strategic Planning.

07 July 2017


Head of the Protocol Challenge Committee

3 Questions for Ralf Bilke

Why don’t more people enroll for clinical trials?

There are multiple reasons and they vary across trials. A mismatch between protocol requirements such as eligibility criteria or concomitant treatments and the clinical reality in the daily practice can be in important enrolment hurdle. And if sites or patients do not understand the benefit of participation in a specific trial, why should they participate?

How to make an understandable and convincing protocol for stakeholders?

The first step will be to understand the expectations of important stakeholders. Their input on individual protocols obtained prior to protocol finalization in order to make protocol adjustments, if needed. We can also learn from stakeholders’ reactions in the past and apply the learning to future protocols.

How do you implement “patient-centricity“ into clinical trials?

Probably via discussions with patient advocacy groups and learnings from previous trials.

Ralf Bilke is a Medical Doctor specialized in Clinical Pharmacology. After several years in the clinic (Internal Medicine / Anaesthesiology) he joined the pharmaceutical industry, worked for a CRO and large pharmaceutical companies. Within Boehringer Ingelheim Ralf held several different positions in Germany and the Netherlands as Phase I investigator, in study management (Phase I to III) and line management in Clinical Operations. He is now the head of the global BI Protocol Challenge Committee and involved in risk assessment and corresponding mitigation strategies.