SELECTED CASE STUDIES
Selected Case Studies from the Agenda
Francois-Xavier FRAPAISEVP Clinical Development, Medical Affairs
Patients as Partners in Clinical Development
Many initiatives have been suggested to optimize clinical trials design and execution; de-risking clinical trials has now become a “buzz-word” in our industry However, practical implementations of the new concept “patient-centricity” are still very limited. We will present our experience in this field, analyze constraints and challenges and present some of the key-success factors.
- From trial design to execution, patients voice matter
- Patients should be involved in the design of patients support and education programs
- Resource and timing constraints often limit the use of Patients Advisory Boards, an issue that could be avoided by careful planning
Bernhard GREVEMedical Director Clinical Development
UCB Biosciences GmbH
Establishing Patient Centricity throughout the Drug Development Lifecycle
Within the current healthcare environment it is most to focus on the patient throughout the entire drug development lifecycle. During this presentation we will review relevant changes in regulatory environment, company approaches to patient centricity and required cultural shifts. We will also discuss opportunities to engage patients along the clinical development continuum.
- How is the regulatory environment evolving in regards to patient centricity
- Company approaches to implement focus on patient needs: starting with the patient
- Requirements for culture change
- Patient engagement: How and when to partner with patients
Ralf BILKEHead of the Protocol Challenge Committee
Protocol Challenge: Oversight Over Operational Study Risks and Corresponding Mitigation Strategies
Clinical Study Protocols are communication media connecting a scientific strategy with tangible actions, assessments, and analyses.
Important stakeholders will perform their benefit-risk assessments based on the protocol with very relevant consequences for the study: health authorities and ethics committees will approve or reject protocols, sites (and patients) will participate in the study or not. Hence, protocols must be understandable and convincing to stakeholders.
Knowledge of the consequences of specific protocol contents (e.g. ethics concerns, misunderstandings, poor patient retention, etc.) helps to better understand protocols related risks. Coupled with an internal protocol challenge this risk assessment will speed up protocol finalization and study conduct and it will help to meet expectations as outlined in ICH E6(R2). This session is meant to be a discussion of risk patterns based on practical examples.
- How can operational risks patterns be identified in study protocols?
- What are typical operational risks in protocols and what are the potential consequences?
- How can the risks be controlled?
- What can a protocol challenge process contribute?
- What is the link to Quality Management as required by ICH E6(R2)
Tariq SETHIVice President Respiratory TMU ECD
Why don’t more people enroll for clinical trials?
Entering a clinical trial often improves outcomes by 10-20%, however, less than 1% of patients enroll in clinical trials. The presentation will explore the factors which limit patient enrollment from an industry/trial , physician and patient perspective.
- Limitations of clinical trials, inclusion and exclusion criteria, regulatory endpoints
- Problems facing physician ethics, patient concerns, pressure of work
- Patients – complexity of trial, time commitment, physical condition