Delivering High-Quality Cancer Care Charting a New Course for a System in Crisis (2013) / Chapter Skim
Currently Skimming:
5 The Evidence Base for High-Quality Cancer Care
5 The Evidence Base for High-Quality Cancer Care
Pages 207-234
The Chapter Skim interface presents what we've algorithmically identified as the most significant single chunk of text within every page in the chapter.
Select key terms on the right to highlight them within pages of the chapter.
From page 207... ...
depicts the evidence base as supporting patient-clinician interactions, because a high-quality cancer care delivery system uses results from scientific research, such as clinical trials and comparative effectiveness research (CER) , to inform medical decisions.
|
From page 208... ...
1999 report Ensuring Quality Cancer Care, which recommended investing in clinical trials to address questions about cancer care management and health services research to understand care patterns associated with good health outcomes (IOM and NRC, 1999)
|
From page 209... ...
How the Evidence Base for Cancer Care Decisions Is Generated Both publicly and privately funded research will be necessary to improve the evidence base for cancer care. For-profit industries generally fund research focused on developing new drugs and devices for treating cancer, while public funders often support research addressing "questions that are important to patients but are less likely to be top priorities of industry" (IOM, 2010b, p.
|
From page 210... ...
As a result, such research often fails to address many additional research questions relevant to clinical care. An IOM report on cancer clinical trials noted that companies often lack incentives to conduct clinical trials that compare the effectiveness of different treatment options already approved for clinical use; combine novel treatments developed by different sponsors; determine optimal duration and dose of drugs in clinical use; or test multimodality treatments, such as radiation therapy, surgery, or devices in combination with drugs (IOM, 2010b)
|
From page 211... ...
CER can be conducted using multiple research methodologies, including clinical trials as well as observational research and systematic reviews (see Box 5-1)
|
From page 212... ...
• n prospective observational studies, the exposure of interest is studied I using data stored in registries, which can require years to accumulate the needed numbers of patients and outcomes. • n cohort studies, groups with certain characteristics or receiving certain I interventions (e.g., premenopausal woman receiving chemotherapy for breast cancer)
|
From page 213... ...
. AHRQ's Effective Health Care Program has completed more than 50 research summaries, systematic reviews, and reports on cancer, as well as other topics relevant to cancer care (e.g., patient-centeredness, end-of-life issues)
|
From page 214... ...
At the same time, older adults are often some of the first individuals using a newly available drug because the majority of cancer patients are over 65 years. When older adults and individuals with comorbidities are underrepresented in cancer clinical trials, clinicians are forced to extrapolate from clinical trials conducted on younger, healthier adults and apply that information to older adults, hoping that the information will be relevant in the older population.
|
From page 215... ...
Trials often have stringent eligibility criteria with regard to comorbidities, concomitant medications, and medical histories. In an evaluation of older adults participating in NCI-sponsored clinical trials, Lewis and colleagues (2003)
|
From page 216... ...
The guidance also encourages, but does not require, the inclusion of individuals over 75 years and suggests that exclusion criteria should focus on issues such as the presence of an illness that could make participation in a clinical trial dangerous or impact the individual's ability to provide informed consent. To assist the FDA in determining how many older adults participated in a clinical trial, the guidance makes recommendations on how to report the age of clinical trial participants (e.g., average age, age of the youngest and oldest participants, and the number of participants who fall into specific age categories)
|
From page 217... ...
. For example, the pediatric patent exclusivity provisions6 provide manufacturers with an additional 6 months of patent protection for conducting clinical trials of their products in children.
|
From page 218... ...
. This committee summarized knowledge contributed by studies conducted under federal programs designed to increase research in children, including the pediatric patent exclusivity (see Box 5-2)
|
From page 219... ...
Thus, the committee recommends that Congress amend patent law to provide patent extensions of up to 6 months for companies that conduct clinical trials of new cancer treatments in older adults or patients with multiple comorbidities (Recommendation 5)
|
From page 220... ...
. The median cost of conducting clinical trials under this program was more than $12 million between 2002 and 2004, and the median net economic benefit to manufacturers was more than $134 million (Li et al., 2007)
|
From page 221... ...
Thus, the committee recommends that the NCI, AHRQ, PCORI, and other CER funders require researchers evaluating the role of standard and novel interventions and technologies used in cancer care to include a plan to study a population that mirrors the age distribution and health risk profile of patients with the disease (Recommendation 5)
|
From page 222... ...
Because of the potential advantages of collecting a broader set of data during clinical trials to improve the quality of cancer care, the committee recommends that the NCI build on ongoing efforts and work with other federal agencies, PCORI, clinical and health services researchers, clinicians, and patients to develop a common set of data elements that captures patient-reported outcomes (PROs) , relevant patient characteristics, and health behaviors that researchers should collect in randomized clinical trials and observational studies (Recommendation 6)
|
From page 223... ...
They could be used to assess whether the cancer care delivery system is providing care that is concordant with patients' needs, preferences, and goals, as well as to assess the impact of providing a type of care on the quality and cost of care. They also have the potential to improve patient safety in clinical studies by identifying adverse events and outcomes that otherwise would go undetected (Basch et al., 2013)
|
From page 224... ...
The NCI should use PROs to gather information from patients, including quality-of-life data, functional status, and adverse events. Biomarkers, Patient Characteristics, and Behavioral Data A recent IOM report recognized the growing need for correlative and translational studies that measure the relationship between biomarkers or other patient characteristics collected during clinical trials and health outcomes (IOM, 2010b)
|
From page 225... ...
. Improving the Use of Information Technology It is impractical to use a clinical trial to answer all research questions relevant to improving the quality of cancer care.
|
From page 226... ...
, the SEERMedicare database, Cooperative Group trials, FDA registration trials, cancer registries, and other sources to conduct systematic reviews and meta-analyses, pooled analyses of patient-level data from many clinical trials, and other types of observational and nonexperimental studies. It would also allow researchers to link patient-level data from multiple sources longitudinally and facilitate the surveillance of long-term side effects and health outcomes from various cancer care plans, as well as capture place of death.
|
From page 227... ...
Summary and Recommendations Because a high-quality cancer care delivery system uses results from scientific research, such as clinical trials and CER, to inform medical decisions, the committee's conceptual framework (see Figure S-2) depicts the evidence base as supporting patient-clinician interactions.
|
From page 228... ...
• ongress should amend patent law to provide patent extensions C of up to 6 months for companies that conduct clinical trials of new cancer treatments in older adults or patients with multiple comorbidities. Recommendation 6: Evidence-Based Cancer Care Goal: Expand the depth of data available for assessing interventions.
|
From page 229... ...
2006. Patient versus clinician symptom reporting using the National Cancer Institute Common Terminology Criteria for Adverse Events: Results of a questionnaire based study.
|
From page 230... ...
European Journal of Cancer Care (Engl)
|
From page 231... ...
2010a. A foundation for evidence-driven practice: A rapid learning system for cancer care: Workshop summary.
|
From page 232... ...
1999. Ensuring quality cancer care.
|
From page 233... ...
2009. American Society of Clinical Oncology guidance statement: The cost of cancer care.
|
From page 234... ...
2013. Publicly funded clinical trials and the future of cancer care.
|
Key Terms
This material may be derived from roughly machine-read images, and so is provided only to facilitate research.
More
information on Chapter Skim is available.