Published on December 13, 2019
- Clinical trials can be for different stages of disease.
- Some clinical trials are designed for pre-treatment or prevention of disease like vaccinations.
- Clinical trials are not just a last resort in treatment.
Are clinical trials only a last resort option? During this clinical trials program highlight, Andy Lee, from Merck, shares his thoughts on trials designed for cancer patients in various disease stages. Watch as Andy explains how researchers are creating avenues in trials for newly diagnosed patients seeking initial therapy, and looking at strategies in the prevention of cancer.
This is a Patient Empowerment Network (PEN) program produced by Patient Power. We thank AbbVie, Inc., Celgene Corporation, Daiichi Sankyo, and Novartis for their support through grants to PEN. These organizations have no editorial control. Patient Power is solely responsible for program content.
I learned about a clinical trial of a new drug and then I ended up on that drug. Thank you!
Transcript | Are Clinical Trials Recommended As an Initial Therapy?
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One of the questions that came in is, “Are trials only for the sickest people or are there of all those trials you talked about opportunities for people who maybe are newly diagnosed or could be their fairly initial therapy?
Yeah, great question. And thank you to the person who asked that. And the answer is that we start in people—because we don’t know if our experimental agent will work. And everyone assumes that new medicines are all going to succeed. And we work in research and researcher because of that many things fail very early on. They fail in phase one before anyone hears of it. It’s normally a code number at that point. And we may just not make the drug soluble enough or it may not be distributed enough.
So, we may have a thing that works in a test tube or a petri dish. But to get that into humans and make sure that it’s safe at the dosage we use often fails. We just don’t progress far enough. So, what we want to make sure of is that firstly the drugs are safe. And there’s a tradeoff between safety and efficacy. We’re constantly trading off. And so, what we do is we look at that and say when someone has no option and we want to get an option going, that’s where we start.
We’ve actually moved down the disease scale, and we’ve come into adjuvant treatment or secondary prevention. And we’ve gone into newer adjuvant is when you have a small tumor is we pretreat to manage that tumor before surgery is done. And post-surgery we hope that there’s limited treatment or no treatment. And we actually have removed the cancer and there would be no evidence of disease. But, of course, using the word cured is something we try not to do, because we prefer to use no evidence of disease.
But absolutely. And the next strategy is prevention of cancer. Our company does a lot of vaccinations in women’s health. We have a product that protects against human papilloma virus which is a precursor for cervical cancer. So, people who are vaccinated with this particular product—and I’m deliberately not using brand names for obvious reasons. But when you vaccinate for HPV, you essentially are preventing the likelihood of a cervical cancer. And there are now prospects in many disease areas where either vaccination or early treatment gives you a tremendous positive prognosis of not getting the disease later on in life.
The answer to your question is yes, we are absolutely looking at ways to prevent getting to a very advanced stage which is very costly to manage and very emotional and stressful and difficult.