Institute of Medicine Calls for Improved Evidence Base

In the ongoing effort to base U.S. cancer care more directly on clinical evidence, trials need to collect broader and deeper evidence on treatment outcomes, declares an Institute of Medicine (IoM) report released on September 10.

Older adults and patients with multiple chronic conditions are “routinely understudied” in clinical trials, and trials often fail to measure outcomes that are important to patients and caregivers, says the report, Delivering High-Quality Cancer Care: Charting a New Course for a System in Crisis.

Noting that most cancer patients are over 65 years of age, the report recommends that the National Cancer Institute (NCI) and other funders require that clinical trials include a plan to study a population that mirrors the age distribution and health risk profile of patients with the disease. To encourage studies in cancer patients who are older or have multiple comorbidities, the report suggests that Congress change patent law to give patent extensions of up to 6 months to companies that sponsor such trials.

The report calls for the NCI to work with other federal agencies, researchers, clinicians, and patients to develop “a common set of data elements that captures patient-reported outcomes, relevant patient characteristics, and health behaviors that researchers should collect from randomized clinical trials and observational studies.”

Additionally, the report proposes the creation of a “learning” health care IT system that systematically collects data on care outcomes and costs, analyzes the captured data both retrospectively and through prospective studies, implements the resulting knowledge into clinical practice, and generates new hypotheses to test. “This kind of a system, using data that's already being collected as part of our health-care delivery, can inform us and tell us where we can do a better job and where our strengths are,” comments Patricia Ganz, MD, a professor at the Schools of Medicine and Public Health at the University of California in Los Angeles.

Ganz chaired the IoM committee of experts who wrote the report, which emphasizes that the U.S. population over age 65 will roughly double by 2030, and that the number of new cancer cases diagnosed annually is expected to rise to 2.3 million by that date.

According to the report, “the oncology workforce may soon be too small to care for the growing population of individuals diagnosed with cancer.”

Addressing a broad sweep of issues in U.S. cancer care, the report also sets the goals of providing better clinical and cost information to patients, offering end-of-life care consistent with patient values, giving team-based care, building core competencies for the health-care workforce, creating a national quality reporting program for cancer care, reducing disparities in access to care, and making care more affordable.