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Patient-Reported Outcomes For Organ Transplant Drugs Could Learn From Other Fields

 
• By Sue Sutter

US FDA staff suggest that oncology and rheumatology instruments could be leveraged or supplemented to make them fit for purpose in assessing toxicity of immunosuppressive regimens in transplant recipients.

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Researchers in the field of solid organ transplant should try to leverage patient-reported outcomes (PRO) instruments from other therapeutic areas, such as cancer and rheumatology, in their bid to develop new, less toxic, immunosuppressive drugs, US FDA officials say.

Although PRO instruments from other fields will not be a perfect fit in the transplant setting, they can be supplemented and further built out with the adverse events and toxicities that are most important to transplant recipients, representatives of the agency’s clinical outcomes assessment (COA) program

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