Contents


seen associated costs rise over the years with an estimated 140% increase in the past decade. With roughly $2.6bn – and 15 years to bring a new drug to market – what can be done to cut costs and raise efficiency? Andrea Valentino talks to Dawn Anderson, managing director, Deloitte Life Sciences R&D and Salman Shah, R&D consulting field of play leader and principal at EY, to find out how optimised clinical supply sourcing, and the clever use of technology and data, can help keep prices down.


Trial design 25 Adapt & thrive


Using an adaptive design for clinical trials can often result in a more efficient, informative and ethical trial over traditional designs. This is often due to the better use of resources and sometimes fewer participants, but what is an adaptive design and what are the advantages of using it in oncology trials? Monica Karpinski speaks to Lillian Siu, senior medical oncologist at the Princess Margaret Cancer Centre and Patrick Wen, MD, director of the Center for Neuro-Oncology at Dana-Farber Cancer Institute, to find how adaptive design differs from the traditional fixed design and what CRO and sponsors can expect from this approach.


29 Transforming clinical landscapes Precision Health Technologies Accelerator


Outsourcing


31 Regulatory pathways for medical device clinical trials Lumis Life Science Consulting


32 Navigating complexities When it comes to clinical trials, sourcing comparators can be a challenge that could expose companies to various roadblocks. There are so many factors to consider, from regulatory and operational risks to cost and waste targets. Tom Rose, SVP of clinical trial sourcing at Clinigen, explains how these risks can be managed and why it’s so important to have a contingency plan in place.


Clinical Trials Insight / www.worldpharmaceuticals.net 5 25 32 22


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