Trial design Adapt & thrive
Using an adaptive design for clinical trials can often result in a more effi cient, 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 fi nd how adaptive design differs from the traditional fi xed design and what CRO and sponsors can expect from this approach.
N
ew cancer drug candidates have just a 3.4% chance of making it through clinical trials. At least, that’s according to 2019 estimates by the Massachusetts Institute of Technology (MIT). Out of all the fields they looked at, oncology trials had the slimmest odds of success. Most of the time, failure is down to a drug not working well enough or causing troublesome side effects. After all, developing effective cancer therapies is very difficult: it’s a problem the medical world has been grappling with for centuries.
On top of that, cancer trials are expensive. They tend to be more complex and take longer than those in other fields, and so require more resources. All of this can put companies off from
developing drugs in challenging fields such as neuro-oncology, says MD, director of the Center for Neuro-Oncology at Dana-Farber Cancer Institute, Patrick Wen.
What if there was a way to lower the bar to entry, making cancer trials quicker and cheaper without compromising their integrity? Adaptive trial design is one possible answer. These are trials that allow for pre-planned adaptations based on interim assessments of data: you decide when you’ll analyse your data and actions you’ll take based on the findings ahead of time. This way, the course of the trial can be modified without deviating from the protocol. With this flexibility, you can gauge whether a treatment holds promise sooner – and
Clinical Trials Insight /
www.worldpharmaceuticals.net
25
elenabsl/
Shutterstock.com
Page 1 |
Page 2 |
Page 3 |
Page 4 |
Page 5 |
Page 6 |
Page 7 |
Page 8 |
Page 9 |
Page 10 |
Page 11 |
Page 12 |
Page 13 |
Page 14 |
Page 15 |
Page 16 |
Page 17 |
Page 18 |
Page 19 |
Page 20 |
Page 21 |
Page 22 |
Page 23 |
Page 24 |
Page 25 |
Page 26 |
Page 27 |
Page 28 |
Page 29 |
Page 30 |
Page 31 |
Page 32 |
Page 33 |
Page 34 |
Page 35 |
Page 36 |
Page 37