Metastatic Cancer Research Studies Should Better Evaluate and Communicate Quality of Life Measures

August 6, 2015

New report from Green Park Collaborative urges new metrics for assessing treatments for advanced disease


Baltimore, MD—August 8, 2015—The Green Park Collaborative, sponsored by the Center for Medical Technology Policy (CMTP), has released an effectiveness guidance document (EGD) recommending that researchers compare metastatic cancer treatment sequences using data from real-world settings, and focusing on outcomes that matter to patients when treatments are not expected to lead to a cure.  The EGD is intended to promote more rapid evidence development to aid patients with incurable cancers who have multiple treatment options but lack evidence to make well-informed choices.

“When patients know that a cure is not possible, other priorities gain importance,” said Donna Messner, PhD, Vice President and Senior Research Director at CMTP. “Beyond side effects, patients want to understand how often they will feel well enough to go to work, how many doctor visits they might need to make, or how much money they will need to spend on therapy and care.”

The EGD calls for measuring ten outcomes using evidence gathered from claims, electronic health records, and other sources.  Beyond overall survival, the EGD recommends outcomes such as “time to first treatment after initial diagnosis of metastatic disease” which, when combined with tumor characteristics and other information, can help patients identify situations where toxic therapy might be delayed without harm.  The EGD also recommends outcomes focused on important but rarely measured elements of patient burden, such as number of visits to a clinic, doctor’s office, or emergency room, and total out-of-pocket costs.

While most of the outcomes can be measured using existing sources, the EGD highlights aspects of data collection in need of improvement, such as developing tools to collect work absenteeism. The EGD also recommends that patient-reported outcomes be routinely collected in clinical trials, routine cancer care, and the patient medical record. Finally, the EGD advocates for standard communication tools to inform patients of the results of these types of comparative studies.

About the Green Park Collaborative-USA
The Green Park Collaborative-USA (GPC) is a multi-stakeholder forum that was established to guide the generation of clinical evidence needed to inform healthcare treatment and coverage decisions in the United States. GPC is a major initiative of the Center for Medical Technology Policy (CMTP).  GPC members include a diverse mix of payers, life sciences companies, patients, clinicians, researchers, and regulators. GPC convenes working groups to develop condition and technology-specific study design recommendations that focus on real-world effectiveness and value, meet the evidence expectations of payers, and are informed by the views of patients and clinicians. 

For more information: /resource-center/view/recommendations-for-comparing-cancer-therapy-sequences/

Julie Simmons
410-547-2687 x116