When you’re developing a new glioblastoma multiforme (GBM) therapy, how do you know when it’s ready for the rigors—and risk—of a clinical trial?
The GBM landscape
As a Grade 4 tumor, GBM is among the most aggressive tumors. Current standard of care may prolong life by a few years but does not provide a full cure. Among the hurdles to finding an effective curative treatment are the immunological challenges due to the presence of the blood-brain barrier and the disease’s molecular heterogeneity.
Every decision counts
As medical research renders a more thorough understanding of glioblastoma multiforme (GBM), the landscape has shifted significantly for therapeutic development. For sponsors with valuable assets at stake, and with the lives of patients in the balance, there is no time to waste and no room for missteps.
To make the most of your groundbreaking achievements in therapeutic development, it is imperative that sponsors be surefooted in clinical trial design and execution.
A readiness checklist
When you have a new GBM therapy in development, how can you know when you are ready to introduce your treatment to human subjects? In a recent GBM fact sheet, Worldwide Clinical Trials’ oncology experts outlined a series of questions a sponsor should be prepared to answer before moving ahead with a GBM clinical trial. Here’s your readiness checklist:
- Establish whether your therapy should be a stand-alone treatment or combined with current standard of care.
- If your investigative therapy is intended to be used in tandem with other treatments, you should be confident that the combined treatments will be compatible.
- Treatment efficacy must be balanced with patient tolerability. This consideration not only impacts the patient’s ability or willingness to stay the course of the study but also has implications for your study’s ability to achieve enrollment targets at the very outset.
- Scientific and medical expertise must align with trial design and execution. To strike the right balance, you’ll need professionals who can effectively braid together science, medicine, and trial methodology.
- You must have a full grasp of regulatory affairs, or partner with someone who does. Trial expertise takes regulatory considerations into account first and foremost. Ideally, you should be relying on a regulatory expert that has strong ties with the necessary agencies and deep knowledge of the applicable regulations.
Ready to talk trials?
Your best chance of success in a GBM clinical trial is to align with clinical trial experts who have been there, done that. The right CRO partner is experienced and equipped to anticipate potential difficulties and act proactively to navigate them.
This is where Worldwide Clinical Trials comes in. Our medical, scientific, and operational experts are experienced in GBM trials, and we don’t believe in one-size-fits-all. We will collaborate with you to determine your development goals and develop a plan tailor-made to meet your unique needs.
For insight on making the leap from lab to clinical trial, read our GMB fact sheet, or contact us directly!
https://bpspubs.onlinelibrary.wiley.com/doi/10.1111/bcp.12881
https://www.frontiersin.org/articles/10.3389/fonc.2015.00055/full
