Katie Goodman on FDA's Efforts to Expand Patient Inclusion Criteria for Clinical Trials

April 11, 2019

The guidances released by the FDA to expand inclusion criteria for cancer clinical trials is a step in the right direction, said Katie Goodman, RN, BSN, CCRP, director of clinical research, Florida Cancer Specialists & Research Institute.

The guidances released by the FDA to expand inclusion criteria for cancer clinical trials is a step in the right direction, said Katie Goodman, RN, BSN, CCRP, director of clinical research, Florida Cancer Specialists & Research Institute.

Transcript

Last month, the FDA published 4 draft guidances and 1 final guidance to expand patient inclusion criteria for cancer clinical trials. Do you think this is a good step forward in having better representation in trials?

I think the FDA guidances were an important step in the right direction with regard to not limiting the patients quite so heavily that can participate in a trial. It’s a fine balance. We want patients to participate in a safe way, but we also know that these drugs, we hope, will be approved and therefore given to patients in the general patient population. So, we don’t want to necessarily not know those other risks that might take place or we know that this drug will be given, for example, to patients who have a history of hepatitis or some other illness or comorbidity that we want to know that perhaps in a clinical trial setting and not later. So, it’s a balance; it’s an important conversation to be had. I think that we are moving in the right direction. I’ve not really seen it in action just yet, but I think that we all understand the need to not so tightly limit what patients can participate in a clinical trial and which ones can’t.