How is patient safety protected in clinical trials?

So clinical trials are ways in which we can advance the treatment options for our patients. And clinical trials vary from one type of trial to the other. There are lots of things that are in place to protect patient safety while they're on a clinical trial. Some of these trials include use of placebo medications, but some of these trials do not include placebo. Specifically, most of our oncologic trials or most of our cancer trials usually have the standard of care treatment options in addition to another agent. So we have to make sure that that agent is appropriate for use in this patient population. So when you talk about a clinical trial and a clinical trial protocol, there's a safety, a scientific committee that looks at safety, that looks at how the trial is designed, you know, how well it applies to the patient population that we're treating, and whether it's of sound scientific background. The other thing, the other ways we look at safety is through data collection. So there is also making sure that any adverse effects of these therapies are identified. And if they're serious enough that we find that the addition of this new medication needs to be paused, we will look at that. We'll pause the trial and look at whether this is something to continue safely in patients or how we can change, adjust the trial so that the medication is safe for patients. There is the data safety monitoring committee or monitoring board that also looks at clinical trials and, you know, confirm whether these trials are safe to be allowed for patients to be a part of. The IRB is an institutional review board. And so the IRB is looking at also safety, but also explaining to patients what the clinical trial is about. So are we informing the patient clearly enough what this trial is about and how the trial is designed and giving them the option of enrolling in the clinical trial versus comparing it to standard of care? So every institution, for lack of a better term, every institution has its own IRB. The institution may have a group of physicians that are part of the IRB, and those physicians may not all be myeloma doctors, for example, for a myeloma trial. It could be other oncologists a part of the board. But they're looking at the trial itself. They're looking at the protocol itself. They're looking at, you know, how well is this protocol explained to patients, especially including any of the side effects that were already known about the new medications that are being included in the clinical study. Clinical trials are a choice. Clinical trials are not deemed necessary in terms of if you decide to be a part of a clinical trial and you agree to be a participant in a clinical trial. At any point during the clinical trial, you can withdraw that decision. So you can, for example, maybe the clinical trial is not something that you think is feasible for you at that point in time. So you have the right to change your mind. And that is with all clinical trials. If you are a participant, you can withdraw your consent. I like to tell patients it's consent, not a contract. So once you sign the consent, that's saying that you read the information, you understand what the information is about the clinical trial, how it's designed, and you're interested in being a part of the study. But later on, if you decide to change your mind for whatever the reason may be, you can let the principal investigator know, you can let the study coordinator know, and then proceed with changing to an alternative therapy.