Breaking down the barriers to clinical trials
We have a problem with clinical trials for people with brain tumors:
Not enough people are enrolling in clinical trials
Many trial sites fail to meet enrollment needs required to conduct trials
In drug development, the term “endpoints” means the desired outcome of a therapy approved by the U.S. Food and Drug Administration (FDA). Therapies include drugs/medications (like Temodar and Avastin) as well as medical devices (such as Optune).
For years, the desired endpoint for brain tumors was overall survival (OS), or the length of life we have after taking the drug.
Sadly, over the last 30 years there has been just 4 approved drugs and 1 approved device to treat brain tumors, and these therapies have made just minor impacts on our OS. In other words, there is no cure for brain cancer. So what if the FDA approved therapies (drugs and devices) based on different endpoints, and not on OS?
I recently attended the Society for Neuro-Oncology Annual Meeting and learned this is something the neuro-oncology community is very interested in.
If not OS, neuro-oncology endpoints might include:
PFS = progression free survival (the time between the first round of treatment and recurrence)
PFS2 = time between 1st and 2nd recurrence
QOL = quality of life, and if the treatment that has a positive impact on other aspects of our disease, for example seizure control or a decrease in neuro-toxicity (the bad stuff treatment does to our brains)
Endpoints are interesting, but designing new endpoints still does not provide a solution to the problems outlined at the start: low trial enrollment.
#BTSM Tweet Chat
On Sunday, December 2, 2018, the #BTSM Twitter chat community is discussing how we can work together to improve the clinical trial process so we may see more therapeutic advancements in our lifetimes (prognosis be damned).
Chat topics include:
Why would one be interested in a clinical trial and at what point?
How should patients learn about clinical trials, from whom, and when? (e.g., Before the first treatment begins, after recurrence, after second recurrence?)
How might we leverage social media to improve patient understanding about clinical trials and mitigate the spread of misinformation?
Barriers: Not all patients live within proximity of a trial site, and health insurance does not cover therapies in the same way. If you had a magic wand, what would you change to make it easier for all patients to have access to clinical breakthroughs?
If you missed this tweet chat or are not on Twitter, share your thoughts with me in the comments below. Thanks for reading.
