How Flexible Are You?
My daughter’s best friend has what I call a “rubber back” – she is extremely flexible and can wrap herself like a pretzel. Contortions that look painful, considering my hamstrings are tighter than the bark on a tree. It’s no wonder it freaks me out.
Flexibility is critical for your health, and also for many aspects of your life. From physical wellbeing, to flexibility with your schedule (and the schedules of children, if you have them, who have more appointments in their day than Bill Gates), to flexibility within your work environment, where your daily schedule can be crumbled in an instant.
We should expect the same flexibility with the scientific analyses that surround us and drive pharmaceutical progress – eventually morphing into new drugs on the market. Saving lives.
It should matter there too.
For research and preclinical studies – there is already much flexibility in how studies are conducted, which is an important part of strategic direction in these early stages.
The modalities of preclinical studies demand a combination of high precision but also a flexible approach in order to sustain momentum in reaching goals. This flexibility is also key to agility in science – you must be able to act upon valid data and re-chart the course as needed. We already have this in preclinical studies. It is refreshing to see this mindset progress to clinical application as well. – Mario Bourdon, President and CSO of BioLaurus, Inc.
Clinical study designs have maintained a consistent and rigid structure for decades. The format and the process was virtually the same as years ago, creating constraints that inhibit flexibility and a claustrophobic process that had to be executed from beginning to end.
In 2012, the FDA released a draft guidance on adaptive design clinical trials – defined as a study that includes a prospectively planned opportunity for modification of the design and hypothesis based on an interim study of data (in a nutshell). (1)
What does this mean?
What if we could stop the study once we saw that it wasn’t working? Or turn on a dime, changing parameters and saving time. Ultimately saving minutes and hours of patient’s lives. About 60% of surveyed life science teams believe that using adaptive design trials in early-stage clinical studies increase the odds of Phase 3 success, according to a recent study by business intelligence provider Cutting Edge Information. (3)
This adaptive study design has also proven to save money spent per patient during clinical trials – pharmaceutical, biotech, and device companies report expenditures up to $120,000 per patient during Phase 1 non-adaptive studies, as compared to $80,000 per patient during Phase 1 adaptive studies – a difference of $40,000 PER PATIENT. (3)
Save $40K per PATIENT? Who wouldn’t want that?
It’s an exciting time for clinical trials as these models create additional flexibility for industry and speed for the eventual customer, and adaptive design is starting to create a positive impact in this direction.
If you are involved in clinical trials, do you consider this type of study design? And how has it worked for you? Feel free to share your thoughts below.
Thank you for taking the time to read this article! Hopefully you enjoyed it!
If you’d like to learn more about preclinical / medical imaging, feel free to visit the website of one of the experts quoted here – Mario Bourdon, President and CSO of BioLaurus. Check out the BioLaurus website.
BioLaurus is a company composed of In-Vivo Preclinical Molecular Imaging Contract Research Specialists. We partner with clients to design and implement successful scientific studies and imaging assays. We are a new kind of contract research company focused on working collaboratively with you to provide solutions to the complex research challenges you face in drug discovery and translational research.
Kimberly Brue-Leone is a business owner, entrepreneur, author, scientific writer and advisor, business development representative, and consultant to various great companies in the Life Sciences. Feel free to check out more on her LinkedIn profile.