Enrollment of Patients With Lung and Colorectal Cancers Onto Clinical Trials
TL;DR: Both practice environment and patient clinical and demographic characteristics are associated with cancer clinical trial enrollment; simultaneous intervention may be required when trying to increase enrollment rates.
Abstract: Purpose: Only 2% to 5% of adult patients with cancer enroll onto clinical trials. We assessed simultaneously characteristics of patients and their physicians that may be independently associated with participation. Methods: CanCORS, a National Cancer Institute (NCI) –funded population-based observational cohort study of newly diagnosed patients with lung and colorectal cancers, sampled patients across five geographic areas, five health care delivery systems, and 15 Veterans Administration hospitals. We linked patient survey and medical record data with physician survey data to examine correlates of trial enrollment. Results: Among 9,901 patients, 5.3% enrolled onto trials. Of the 9,901 patients, we linked 6,506 patients to one medical oncologist, surgeon, or radiation oncologist (physicians, N 1,325) who responded to the physician survey and was considered their primary cancer clinician decision maker. Patient age, race, disease stage, geographic region, and health insurance were independently associated with trial enrollment. Physician factors independently associated with patient trial enrollment were being a medical oncologist, practicing at an NCI-designated cancer center, taking the lead in discussing trials with patients, and receiving increased income from trial enrollment. After simultaneously adjusting for patient and physician characteristics, only being a physician practicing at an NCI-designated cancer center (odds ratio [OR], 1.65; 95% CI, 1.19 to 2.27) and patient female sex (OR, 1.36; 95% CI, 1.10 to 1.68), age 70 versus 50 years (OR, 0.28; 95% CI, 0.16 to 0.48), and advanced disease (OR, 1.85; 95% CI, 1.45 to 2.37) remained independently associated with trial enrollment. Conclusion: Both practice environment and patient clinical and demographic characteristics are associated with cancer clinical trial enrollment; simultaneous intervention may be required when trying to increase enrollment rates.
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TL;DR: Common patterns in reported successful trials are identified, including factors regarding the study site, study coordinator/investigator, and the effects on participating patients.
Abstract: Clinical trials are time consuming, expensive, and often burdensome on patients. Clinical trials can fail for many reasons. This survey reviews many of these reasons and offers insights on opportunities for improving the likelihood of creating and executing successful clinical trials. Literature from the past 30 years was reviewed for relevant data. Common patterns in reported successful trials are identified, including factors regarding the study site, study coordinator/investigator, and the effects on participating patients. Specific instances where artificial intelligence can help improve clinical trials are identified.
201 citations
Cites background from "Enrollment of Patients With Lung an..."
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TL;DR: These findings emphasize the enormous need to address structural and clinical barriers to trial participation, which combined make trial participation unachievable for more than three of four cancer patients.
Abstract: Background Barriers to cancer clinical trial participation have been the subject of frequent study, but the rate of trial participation has not changed substantially over time. Studies often emphasize patient-related barriers, but other types of barriers may have greater impact on trial participation. Our goal was to examine the magnitude of different domains of trial barriers by synthesizing prior research. Methods We conducted a systematic review and meta-analysis of studies that examined the trial decision-making pathway using a uniform framework to characterize and quantify structural (trial availability), clinical (eligibility), and patient/physician barrier domains. The systematic review utilized the PubMed, Google Scholar, Web of Science, and Ovid Medline search engines. We used random effects to estimate rates of different domains across studies, adjusting for academic vs community care settings. Results We identified 13 studies (nine in academic and four in community settings) with 8883 patients. A trial was unavailable for patients at their institution 55.6% of the time (95% confidence interval [CI] = 43.7% to 67.3%). Further, 21.5% (95% CI = 10.9% to 34.6%) of patients were ineligible for an available trial, 14.8% (95% CI = 9.0% to 21.7%) did not enroll, and 8.1% (95% CI = 6.3% to 10.0%) enrolled. Rates of trial enrollment in academic (15.9% [95% CI = 13.8% to 18.2%]) vs community (7.0% [95% CI = 5.1% to 9.1%]) settings differed, but not rates of trial unavailability, ineligibility, or non-enrollment. Conclusions These findings emphasize the enormous need to address structural and clinical barriers to trial participation, which combined make trial participation unachievable for more than three of four cancer patients.
122 citations
Cites background from "Enrollment of Patients With Lung an..."
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TL;DR: The need to collect protected health information as defined under the Health Insurance Portability and Accountability Act of 1996 to drive rapid learning through CancerLinQ is addressed.
Abstract: The ever-increasing volume of scientific discoveries, clinical knowledge, novel diagnostic tools, and treatment options juxtaposed with rising costs in health care challenge physicians to identify, prioritize, and use new information rapidly to deliver efficient and high-quality care to a growing and aging patient population. CancerLinQ, a rapid learning health care system in oncology, is an initiative of the American Society of Clinical Oncology and its Institute for Quality that addresses these challenges by collecting information from the electronic health records of large numbers of patients with cancer. CancerLinQ is first and foremost a quality measurement and reporting system through which oncologists can harness the depth and power of their patients' clinical records and other data to assess, monitor, and improve the care they deliver. However, in light of privacy and security concerns with regard to collection, use, and disclosure of patient information, this article addresses the need to collect protected health information as defined under the Health Insurance Portability and Accountability Act of 1996 to drive rapid learning through CancerLinQ.
44 citations
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TL;DR: In this article, the authors investigated the impact of a cancer care equity program (CCEP) on CT enrollment and assessed barriers to cancer clinical trial participation and found that financial concerns represent a major barrier to patient participation in clinical trials.
Abstract: INTRODUCTION Cancer clinical trial (CT) participation rates are low and financial barriers likely play a role. We implemented a cancer care equity program (CCEP) to address financial burden associated with trial participation. We sought to examine the impact of the CCEP on CT enrollment and to assess barriers to participation. METHODS We used an interrupted time series design to determine trends in CT enrollment before and after CCEP implementation. Linear regression models compared trial enrollment before and after the CCEP. We also compared patient characteristics before and after the CCEP and between CCEP and non-CCEP participants. We surveyed CCEP and non-CCEP participants to compare pre-enrollment financial barriers. RESULTS After accounting for increased trial availability and the trends in accrual for prior years, we found that enrollment increased after CCEP implementation (18.97 participants per month greater than expected; p < .001). A greater proportion of CCEP participants were younger, female, in phase I trials, lived farther away, had lower incomes, and had metastatic disease. Of 87 participants who completed the financial barriers survey, 49 CCEP and 38 matched, non-CCEP participants responded (63% response rate). CCEP participants were more likely to report concerns regarding finances (56% vs. 11%), medical costs (47% vs. 14%), travel (69% vs. 11%), lodging (60% vs. 9%), and insurance coverage (43% vs. 14%) related to trial participation (all p < .01). CONCLUSION CT participation increased following implementation of the CCEP and the program enrolled patients experiencing greater financial burden. These findings highlight the need to address the financial burden associated with CT participation. IMPLICATIONS FOR PRACTICE Financial barriers likely discourage patients from participating in clinical trials. Implementation of a cancer care equity program (CCEP) seeking to reduce financial barriers by assisting with travel and lodging costs was associated with increased trial accrual. The CCEP provided assistance to patients particularly in need, including those living farther away, those with lower incomes, and those reporting financial barriers related to trial participation. These findings suggest that financial concerns represent a major barrier to patient participation in clinical trials and underscore the importance of efforts to address these concerns.
41 citations
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TL;DR: Among patients with lung or colorectal cancer, frequent physician tumor board engagement was associated with patient clinical trial participation and higher rates of curative-intent surgery for stage I to II NSCLC but not with overall survival.
Abstract: Among patients with lung or colorectal cancer, frequent physician tumor board engagement was associated with patient clinical trial participation and higher rates of curative-intent surgery for stage I to II NSCLC but not with overall survival.
40 citations
References
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TL;DR: Although the total number of trial participants increased during the study period, the representation of racial and ethnic minorities decreased and were less likely to enroll in cooperative group cancer trials than were whites, men, and younger patients, respectively.
Abstract: ContextDespite the importance of diversity of cancer trial participants with
regard to race, ethnicity, age, and sex, there is little recent information
about the representation of these groups in clinical trials.ObjectiveTo characterize the representation of racial and ethnic minorities,
the elderly, and women in cancer trials sponsored by the National Cancer Institute.Design, Setting, and PatientsCross-sectional population-based analysis of all participants in therapeutic
nonsurgical National Cancer Institute Clinical Trial Cooperative Group breast,
colorectal, lung, and prostate cancer clinical trials in 2000 through 2002.
In a separate analysis, the ethnic distribution of patients enrolled in 2000
through 2002 was compared with those enrolled in 1996 through 1998, using
logistic regression models to estimate the relative risk ratio of enrollment
for racial and ethnic minorities to that of white patients during these time
periods.Main Outcome MeasureEnrollment fraction, defined as the number of trial enrollees divided
by the estimated US cancer cases in each race and age subgroup.ResultsCancer research participation varied significantly across racial/ethnic
and age groups. Compared with a 1.8% enrollment fraction among white patients,
lower enrollment fractions were noted in Hispanic (1.3%; odds ratio [OR] vs
whites, 0.72; 95% confidence interval [CI], 0.68-0.77; P<.001) and black (1.3%; OR, 0.71; 95% CI, 0.68-0.74; P<.001) patients. There was a strong relationship between age and
enrollment fraction, with trial participants 30 to 64 years of age representing
3.0% of incident cancer patients in that age group, in comparison to 1.3%
of 65- to 74-year-old patients and 0.5% of patients 75 years of age and older.
This inverse relationship between age and trial enrollment fraction was consistent
across racial and ethnic groups. Although the total number of trial participants
increased during our study period, the representation of racial and ethnic
minorities decreased. In comparison to whites, after adjusting for age, cancer
type, and sex, patients enrolled in 2000 through 2002 were 24% less likely
to be black (adjusted relative risk ratio, 0.76; 95% CI, 0.65-0.89; P<.001). Men were more likely than women to enroll in
colorectal cancer trials (enrollment fractions: 2.1% vs 1.6%, respectively;
OR, 1.30; 95% CI, 1.24-1.35; P<.001) and lung
cancer trials (enrollment fractions: 0.9% vs 0.7%, respectively; OR, 1.23;
95% CI, 1.16-1.31; P<.001).ConclusionsEnrollment in cancer trials is low for all patient groups. Racial and
ethnic minorities, women, and the elderly were less likely to enroll in cooperative
group cancer trials than were whites, men, and younger patients, respectively.
The proportion of trial participants who are black has declined in recent
years.
1,536 citations
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TL;DR: The past 10 years have seen the spectacular growth of a new research model, and commercially oriented networks of contract-research organizations (CROs) and site-management organizations (SMOs) have altered.
Abstract: Clinical practice is changing rapidly. New cardiovascular drugs, antiinflammatory drugs, cancer chemotherapy, and other pharmacologic weapons are being added to physicians' therapeutic armamentarium virtually daily. Most clinical studies that bring new drugs from bench to bedside are financed by pharmaceutical companies. Many of these drug trials are rigorously designed, employing the skills of outstanding clinical researchers at leading academic institutions. But academic medical centers are no longer the sole citadels of clinical research. The past 10 years have seen the spectacular growth of a new research model. Commercially oriented networks of contract-research organizations (CROs) and site-management organizations (SMOs) have altered . . .
754 citations
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TL;DR: The results indicated that underrepresented populations face numerous barriers to participation in cancer‐related trials, and the available evidence had limitations in quality regarding representativeness, justification of study methods, the reliability and validity of data‐collection methods, potential for bias, and data analysis.
Abstract: Racial and ethnic minorities, older adults, rural residents, and individuals of low socioeconomic status are underrepresented among participants in cancer-related trials. The authors conducted a systematic review to determine the barriers to participation of underrepresented populations in cancer-related trials. Their search included English-language publications that reported original data on the recruitment of underrepresented groups to cancer treatment or prevention trials between 1966 and December 2005 in multiple electronic databases. They also hand-searched titles in 34 journals from January 2003 to December 2005 and they examined reference lists for eligible articles. Titles and abstracts were reviewed to identify relevant studies. Data on barriers to participation were synthesized both qualitatively and based on statistically significant associations with trial enrollment. Of 5257 studies that were cited, 65 studies were eligible for inclusion in the current analysis, including 46 studies on recruitment into cancer therapeutic trials, 15 studies on recruitment into prevention trials, and 4 studies on recruitment into both prevention and treatment trials. Numerous factors were reported as barriers to participation in cancer-related trials. However, only 20 of the studies reported statistically significant associations between hypothesized barriers and enrollment. The available evidence had limitations in quality regarding representativeness, justification of study methods, the reliability and validity of data-collection methods, potential for bias, and data analysis. The results indicated that underrepresented populations face numerous barriers to participation in cancer-related trials. The current systematic review highlighting the literature on recruitment of underrepresented populations to cancer trials and may be used as the evidence base toward developing an agenda for etiologic and intervention research to reduce the disparities in participation in cancer-related trials.
733 citations
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TL;DR: The number of oncologists and the presence of approved cancer programs both were significantly associated with increased accrual to clinical trials, and the highest observed accruals was in suburban counties.
Abstract: PURPOSE: We chose to examine the impact of socioeconomic factors on accrual to National Cancer Institute (NCI)–sponsored cancer treatment trials. PATIENTS AND METHODS: We estimated the geographic and demographic cancer burden in the United States and then identified 24,332 patients accrued to NCI-sponsored cancer treatment trials during a 12-month period. Next, we examined accrual by age, sex, geographic residence, health insurance status, health maintenance organization market penetration, several proxy measures of socioeconomic status, the availability of an oncologist, and the presence of a hospital with an approved multidisciplinary cancer program. RESULTS: Pediatric patients were accrued to clinical trials at high levels, whereas after adolescence, only a small percentage of cancer patients were enrolled onto clinical trials. There were few differences by sex. Black males as well as Asian-American and Hispanic adults were accrued to clinical trials at lower rates than white cancer patients of the sam...
450 citations
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TL;DR: The authors believe that the idea of payment of physicians for providing high-quality care, on the basis of explicit measures of quality, is worth pursuing, but they point out important impediments and challenges to its successful implementation.
Abstract: Payment incentives as a part of physicians' compensation are commonplace but have been aimed predominantly at restricting expensive services. A novel concept is the payment of physicians for providing high-quality care, on the basis of explicit measures of quality. Such a system has recently been adopted in the United Kingdom. The authors believe that the idea is worth pursuing, but they point out important impediments and challenges to its successful implementation.
318 citations