How Do Medical Affairs and Regulatory Affairs Professionals Co-Create The Regulatory Strategy From The Beginning?
New ways clinical trials and real-world studies will be conducted…
How can early partnering with patients and healthcare professionals optimize clinical trial performance?
Clinical trials are the foundation for the development of innovative therapies. It is in the interest of all healthcare stakeholders to execute trials fast and with high quality, to bring innovative therapies to patients faster. Yet we design trials in a way that makes it difficult to execute trials fast and easy for people involved. How can we do better?
It is crucial to embrace the power of partnership from the very beginning and throughout the development to accelerate the delivery of innovative therapies. Together, we can provide the best trial experience and serve unmet needs faster. In a recent case study, we partnered with patient representatives to optimize the design of our first clinical trial in a new disease area for Boehringer Ingelheim. We initiated this partnership more than one year before the trial started and optimized many aspects of the trial design together including restrictions on co-medication, endpoints and study information for patients. The trial recruited in half of the planned time.
What are your key learnings from this case study and other Boehringer Ingelheim initiatives?
Most importantly, start partnering with patients and healthcare professionals early when you have an initial concept of the trial. Once you learn about the relevant obstacles from patients and healthcare professionals, we need to push for finding solutions instead of seeking reasons why these cannot be addressed. Further, we need to build upon learnings and continuously challenge and optimise our internal processes and capabilities.
Kimberley Kallsen, Head of Patient & Site Journey, Global Clinical Development & Operations at Boehringer Ingelheim is a cell biologist by training and holds a PhD and a master in public health. She joined Boehringer Ingelheim in 2013, worked in different global strategic and operational roles including medical writing, scientific publications, patient engagement, and is currently Head of Global Clinical Development & Operations Patient & Site Engagement. She is passionate about early partnerships with patient representatives and healthcare professionals to ensure patient- and site-centric clinical trials.