Katie Goodman Discusses Clinical Trial Participation Criteria's Impact on Trial Participation

Clinical trial criteria is really about patient safety and making sure participating patients don't experience undue risks, explained Katie Goodman, RN, BSN, CCRP, director of clinical research, Florida Cancer Specialists & Research Institute.

Transcript

How does current clinical trial criteria limit participation in clinical trials among patients with cancer?

Cancer is a complicated disease and it is a disease of the elderly, so often times, there are other disease states that are happening. They might have cardiovascular disease or high blood pressure, for example. Or have had maybe a prior cancer and this is not their first cancer. So, clinical trials define who can participate and can be very detailed, down to do they have controlled hypertension, for example. If perhaps it’s not controlled, then sometimes a clinical trial will tend to not want that patient to participate.

It’s really about patient safety, and I think that that’s what is in mind when they are writing these protocols, to really make sure that the patients that are participating in investigational therapy are not going to unintentionally have undue risks that we don’t want to happen with the average patient. So yes, we do have to think about that, and we do have to consider the total patient and not just the cancer when we’re deciding whether or not a patient is able to participate in a clinical trial. Those things are typically defined up front, and conversations can happen with the patient along the way before they ever even start to participate.