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Presentation 2: Incorporating Patient-Centered Outcomes in Clinical Trials

Ethan Basch, MD
Ethan Basch, MD, a self-described triple-threat, discusses incorporating patient-centered outcomes into clinical trials. He begins his presentation by describing a colleague's published research article, Pazopanib versus Sunitinib in Metastatic Renal-Cell Carcinoma. The study found that not only did Pazopanib cost an estimated $5800 and Sunitinib $7800, but Pazopanib was superior to Sunitiniib in 11 out of 14 quality-of-life indicators.
Ethan Basch, MD, a self-described “triple-threat,” discusses incorporating patient-centered outcomes into clinical trials. He begins his presentation by describing a colleague’s published research article, “Pazopanib versus Sunitinib in Metastatic Renal-Cell Carcinoma.” The study found that not only did Pazopanib cost an estimated $5800 and Sunitinib $7800, but Pazopanib was superior to Sunitiniib in 11 out of 14 quality-of-life indicators.

Dr Basch goes on to explore the clinical evidence of other studies. He says this kind of information is valuable to patient decision making and estimating comparative benefit-risk between treatments, and because it is currently very difficult to find this type of research.

“For patient decision making, of course, patients wish to know what the experiences of people like them were like in a similar context previously, either within trial context, or real-world or not trial context,” he says.

Patient-reported outcomes (PROs), Dr Basch says, are the “gold standard” in collecting information best known by patients. PROs are reported directly by a patient (and sometimes by a caregiver) without filtering by a health professional.

Patient-centered outcomes (PCOs are also important for meaningful healthcare decision making, especially in specific populations. PCOs are not necessarily patient reported, and PROs are not necessarily patient centered.

Groups like PCORI have particularly honed in on patient-centered research. Dr Basch says any researchers who are funded by PCORI must adhere to their standards, which include engaging “people representing the population of interest and other relevant stakeholders in ways that are appropriate and necessary in a given research context.”

There may be challenges in engaging patient populations in self reporting, but their participation could provide valuable information to support decisions by multiple stakeholders.

 


 
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