cancer clinical trial participation statistics

Uptake of Breast Cancer Clinical Trials at Minority Serving Cancer Centers. In the end, the potential benefits of trial participation will be shared by patients, researchers, and future generations. The Office of the Inspector General has released guidance regarding the use of clinical trial websites, indicating that IRB approval of a clinical trial listing, if limited to selected basic information, is not required.108, InVentiv Health, a contract research organization, has provided specific plans to assist researchers to plan digital recruitment campaigns (Table 2).109 Their plans are premised on the idea that recruitment for global clinical trials is an area ripe for re-engineering. Crit Care Med. Domestic trials may also partner with international collaborators to augment trial enrollment. Even if a trial is available, patients may not be eligible. The predominant reason that trials fail to complete is poor accrual.126 These failures represent a lost investment on the part of funding agencies. It has been consistently estimated that less than 5% of adult patients with cancer enroll in cancer clinical trials.1, 2 Conversely, the vast majority of adult patients with cancer (greater than 95%) do not participate in clinical trials, even though 70% of Americans are estimated to be inclined or very willing to participate in clinical trials.3 Thus, a large gap exists between trial participation rates and the willingness of patients to participate, suggesting that barriers to trial participation are numerous and frequently insurmountable. Advertisers, Journal of Clinical Oncology Estimated Treatment Trial Accrual Proportion of Patients Diagnosed With Cancer From 2008 to 2010 by Single Year of Age and the History of SEER Representation of the United States Population, Accrual data from the NCI Cancer Therapy Evaluation Program (CTEP) were provided by Steve Friedman, Michael Montello, Troy Budd, and Samantha Finnegan via the Freedom of Information Act. It is recognized that there is greater fluidity between these categories than the model allows, but simplifications were made to facilitate discussion. Survival data were obtained from SEER 18 regions.77 Accrual data from the NCI Cancer Therapy Evaluation Program (CTEP) were provided by Steve Friedman, Michael Montello, Troy Budd, and Samantha Finnegan via the Freedom of Information Act. The inset compares the APC in 5-year survival rate with the treatment trial accruals. Roche: participation of patients in clinical trials 2009-2017 Leading global contract research organizations based on revenue 2019 The most important statistics Access to a clinic can be influenced by many different structural factors such as transportation, travel costs, access to insurance, and availability of child care.16 Uninsured patients, in particular, present with later stage of disease and have worse cancer outcomes.17,18 To the extent that such patients present at their cancer diagnosis with a greater comorbid burden, their likelihood of eventually participating in a clinical trial is lower.19, Once a patient has access to cancer care, a major structural barrier pertains to the availability of a clinical trial for the patient’s histology and stage. International observational atopic dermatitis cohort to follow natural history and treatment course: TARGET-DERM AD study design and rationale. Disparities in participation in cancer clinical trials. Relationships may not relate to the subject matter of this manuscript. Paper presented at: National Cancer Institute American Society of Clinical Oncology Cancer Trial Accrual Symposium: Science and Solutions; April 2010; Bethesda, MD. Methods: A total of 158 women were treated for ovarian cancer at a regional cancer center. Absolute and Relative Trial Accrual Rates to NCI Treatment Trials: Comparison of 2001 to 2003 Versus 2007 to 2009 Estimates, Comparison of 2001 to 2003 versus 2007 to 2009 for annual accruals to treatment trials sponsored by National Cancer Institute (NCI)-sponsored cooperative groups and NCI-designated cancer centers (red curves) and accrual proportion of all patients in the United States with invasive cancer into the trials by 5-year age intervals (green curves), by single years of age. We also consider the specific case of adolescents with cancer and show that the low rate of trial enrollment in this age group strongly correlates with limited improvements in cancer population outcomes compared with other age groups. Main outcome measure: FIGURE 5. E-Recruiting: using digital platforms, social, media, and mobile technologies to improve clinical trial enrollment. 1, 2 Conversely, the vast majority of adult patients with cancer (greater than 95%) do not participate in clinical trials, even though 70% of Americans are estimated to be inclined or very willing to participate in clinical trials. But, they may not do so in an efficient manner, and cancer population survival gains may be lost in the process. Among patients for whom a trial is available, about half (or a quarter of all patients) are excluded due to eligibility issues with trial exclusion criteria. Institute of Medicine. ASCO Meetings National Cancer Institute. Accrual data from the National Cancer Institute Cancer Therapy Evaluation Program (CTEP) were provided by Steve Friedman, Michael Montello, Troy Budd, and Samantha Finnegan via the Freedom of Information Act. Doctors use clinical trials to develop new treatments for serious diseases such as cancer. From the Fred Hutchinson Cancer Research Center, Seattle, WA; The University of Texas MD Anderson Cancer Center, Houston, TX; Centers for Disease Control and Prevention, Atlanta, GA; St. Charles Health System, Quality Department, Bend, OR. Chen MS Jr, Lara PN, Dang JH, Paterniti DA, Kelly K. Cancer. DOI: 10.1200/EDBK_156686 American Society of Clinical Oncology Educational Book 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). 10.Pishvaian MJ, Blais EM, Brody JR, et al. The U.S. Food and Drug Administration (FDA) has provided no specific guidance on the use of social media in clinical research.107 The Recruitment Information Sheet states that in the case of direct advertising, the information and mode of communication should be reviewed by the IRB for evidence of coercion or implication of benefits to participation. Clipboard, Search History, and several other advanced features are temporarily unavailable. Cookies, UNDERSTANDING BARRIERS TO CLINICAL TRIAL PARTICIPATION, Demographic and Socioeconomic Disparities, EVIDENCE FOR THE BENEFIT OF CLINICAL TRIALS ON CANCER POPULATION OUTCOMES OBSERVED THROUGH THE RELATIVE LACK OF PROGRESS IN ADOLESCENTS AND YOUNG ADULTS, GLOBAL AND LOCAL STRATEGIES TO IMPROVE CLINICAL TRIAL PARTICIPATION, Strategies to Address Demographic and Socioeconomic Barriers, AUTHORS' DISCLOSURES OF POTENTIAL CONFLICTS OF INTEREST. Please enable it to take advantage of the complete set of features! Comparison of Average Percent Change in the 5-Year Cancer Survival Rate and Treatment Trial Accruals, by 5-Year Age Intervals. About Faster accrual would enable trials to be conducted more quickly. Enrollment of children (younger than age 15) to clinical trials has historically been much higher than for adult cancers (greater than 50%).2,6,7 At the same time, mortality rates have for children have been decreasing since the 1970s, whereas for adults they have been decreasing only since the 1990s.8 The average reduction in the rate of mortality from 1975 to 1995 was 2.6% per year for patients younger than age 20.9 Interestingly, the reduction was weakest among older children (age 15 to 19; 2.0% per year), reflecting other studies which have found both lower trial enrollment for adolescents and young adults with cancer and lower rates of mortality reduction.10,11. To characterize the representation of racial and ethnic minorities, the elderly, and women in cancer trials sponsored by the National Cancer Institute. Butts CA, Socinski MA, Mitchell P, et al. Conclusions: Under this rubric, greater participation leads to greater generalizability, which leads to better cancer population outcomes. Both patients and physicians have been found to regard clinical trial participation as a positive approach to cancer care.3 Despite this, the complexity of the enrollment process and the potential barriers faced by patients have combined to make a successful clinical trial enrollment a rare event. Although barriers to trial participation have been the subject of frequent study, the rate of trial participation has not changed substantially over time. On the one hand, eligibility must be sufficiently narrow to produce a treatment effect that is approximately consistent across the cohort. By extension, this observation also points to the need to increase trial enrollment for patients of any age group, or any demographic group, because this could have a beneficial impact on increasing survival and reducing mortality from cancer. National Center for Biotechnology Information, Unable to load your collection due to an error, Unable to load your delegates due to an error. 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. The red bars indicate the adolescent and young adult (AYA) age group. Although this comparison is confounded by time, there was a nearly 1:1 correlation over the entire age range that was strongly significant. Gross CP, Filardo G, Mayne ST, Krumholz HM. In the United States, the practice of paying patients for trial participation is widespread, but also contentious, highly variable, and lacking in general guidance.122 One concern is that a payment inducement might alter a subject’s assessment of potential risks or impair their judgment, although there is little evidence that payment inducements do or do not affect assessment.123,124 A careful calibration of the size of any monetary incentive would be necessary to avoid undue influence.125, Measures to address socioeconomic disparities in recruitment may have a preferentially beneficial impact on minority patients. It has been consistently estimated that less than 5% of adult patients with cancer enroll in cancer clinical trials. Gaumond B, Ferrande L, Houde J, et al. Participation in surgical oncology clinical trials: gender-, race/ethnicity-, and age-based disparities. Barriers to trial participation are structural, clinical, and attitudinal, and they differ according to demographic and socioeconomic factors. Given the need to accrue large numbers of patients in a shortened timeline and the increased complexity of U.S.-based clinical trials, academic and industry sponsors are increasingly exploring regions outside of the United States to conduct trials, including in less developed regions of the world. Speakers' Bureau: Jazz Pharmaceuticals, Shire. Unfortunately, this has the effect of excluding many patients from trials, especially older patients with a greater comorbid burden.28,57,58 Further, trials typically exclude patients with prior cancers, even as the population of cancer survivors in the United States is growing and which currently numbers around 15 million.111 In this context, one strategy to remove barriers to trials would be to remove unnecessary eligibility criteria. Version 4.1.1. Figure 3 shows the relationship between the average percent change (APC) in the 5-year cancer-specific survival rate from 1985 to 1999 and the accrual rate to national cancer treatment trials during 2001 to 2006. 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. Descriptive statistics will be summarized and the blood and tissue marker data will be correlated with clinical endpoints (response, DCR12, duration of response, OS, PFS, adverse events, etc.).  |  Often researchers using Facebook attempt to recruit from the initial audience prior to forming a relationship. We found a slower rate of progress in AYAs compared with younger and older patients, which underscores the need to increase the number of clinical trials available to AYAs with cancer and their participation in them. Sites also provided reimbursement for food and/or transportation costs expended to participate in the trial.62. Enrollment fraction, defined as the number of trial enrollees divided by the estimated US cancer cases in each race and age subgroup. Increasingly, social media platforms provide an opportunity to communicate about clinical trials with potential trial researchers and participants.104 The Quorum Review Institutional Review Board (IRB) offered the following considerations for a plan to use social media in research105,106: Provide a rationale for the application of social media to the target population. Our focus was a natural observational contrast between AYAs and other age groups with cancer. The following represents disclosure information provided by authors of this manuscript. Gynecologic Cancer Clinical Trials: What This Means for You is a 19-minute video for patients who might be interested in participating in a gynecologic cancer clinical trial. The investigators design this study to determining how patients makes decisions about participating in a clinical trial and … Barriers to trial participation have been the subject of frequent study, but the rate of trial participation has not changed substantially over time. Address the privacy and confidentiality concerns of the social media applications to be used. Is asparaginase a critical component in the treatment of acute lymphoblastic leukemia? In addition, we consider the distinction between clinical trial enrollment between children and adolescents with cancer. DOI: 10.1200/EDBK_156686 American Society of Clinical Oncology Educational Book - 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. This is unfortunate given the frequency with which the direct and indirect costs of trial participation have been cited as meaningful barriers.41 Two recent articles overcame this limitation. For more information about ASCO's conflict of interest policy, please refer to www.asco.org/rwc. NCT02043587. Joinpoint analysis identified two inflections, ages 17 and 20, during which the 5-year survival rate decreased 23%. Transforming Clinical Research in the United States: Challenges and Opportunities: Workshop Summary. On the other hand, eligibility should be sufficiently inclusive that the trial targets a meaningful population of patients for whom a new treatment would apply.25 Eligibility criteria may also exclude patients due to safety concerns. DESIGN, SETTING, AND PATIENTS: Cross-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. Case-linked analysis of clinical trial enrollment among adolescents and young adults at a National Cancer Institute-Designated comprehensive cancer center, Adolescent and young adult patients with cancer: a milieu of unique features, Children’s Oncology Group’s 2013 blueprint for research: adolescent and young adult oncology, Enhancing adolescent and young adult oncology research within the National Clinical Trials Network: Rationale, progress, and emerging strategies, Survival patterns in teenagers and young adults with cancer in the United Kingdom: Comparisons with younger and older age groups, The National Cancer Institute-American Society of Clinical Oncology Cancer Trial Accrual Symposium: summary and recommendations, The global conduct of cancer clinical trials: challenges and opportunities, Goserelin for ovarian protection during breast-cancer adjuvant chemotherapy, Exploring the viability of using online social media advertising as a recruitment method for smoking cessation clinical trials, An examination of eClinical Technology usage and CDISC standard adoption, Participation of the elderly population in clinical trials: barriers and solutions, Can older cancer patients tolerate chemotherapy? The more rapid completion of trials would enable new treatments to be developed more quickly. Informed consent documents rarely include the risk of closure because of lack of study participation, despite the fact that about one in four randomized, phase III trials have such an outcome.126. If a trial is available, an evaluation of trial eligibility is made, and, if eligible, a trial is discussed with the patient. Despite 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. In the authors’ view, the globalization of clinical research “is vital to speed up availability of life-saving medicines throughout the world.”99 In the setting of a domestic clinical trial system that has been described as being in a state of crisis, this view has added weight.12. In both cases, the correlation between trial enrollment and, respectively, APC in 5-year survival and mortality is clearly evident and highly significant (p < .001). Context Despite 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.. A better approach may be to grow and engage your audience first, before patients are recruited.110, TABLE 2. Implement risk-based monitoring and clinical inspection. Low clinical trial participation is a problem that’s plagued cancer research for decades, with most estimates putting adult cancer patient involvement at less than 5 percent. The trial may then be offered to the patient, at which point the patient makes a decision about whether to participate. Age-, sex-, and race-based differences among patients enrolled versus not enrolled in acute lung injury clinical trials. With over 70,000 AYAs diagnosed with cancer in the United States annually, and 7600 diagnosed in Canada, this group represents approximately 4–5% of the North American adult cancer population [1,2,3].Lack of enrolment of AYA onto cancer clinical trials (CCT) has been the focus of … A prospective pilot study, Comparison of toxicity experienced by older versus younger patients enrolled in breast cancer clinical trials, Chemotherapy in the oldest old: the feasibility of delivering cytotoxic therapy to patients 80 years old and older, Use of comprehensive geriatric assessment in older cancer patients: recommendations from the task force on CGA of the International Society of Geriatric Oncology (SIOG), Comprehensive geriatric assessment for older patients with cancer, Frailty screening methods for predicting outcome of a comprehensive geriatric assessment in elderly patients with cancer: a systematic review, Identifying an accurate pre-screening tool in geriatric oncology, Detecting disabilities in older patients with cancer: comparison between comprehensive geriatric assessment and vulnerable elders survey-13, Assessment and treatment of elderly patients with cancer, Payment of research subjects involved in clinical trials is unethical, An analysis of U.S. practices of paying research participants, The scientific impact of positive and negative phase 3 cancer clinical trials, In and out, good and bad news, of generalizability of SWOG treatment trial results, American Society of Clinical Oncology Educational Book, http://www.cancer.gov/research/areas/clinical-trials/nctn/budget#1, https://www.cms.gov/Medicare/Coverage/ClinicalTrialPolicies/downloads/finalnationalcoverage.pdf, http://www.census.gov/popest/data/intercensal/national/nat2010.html, https://clinicaltrials.gov/ct2/show/NCT02043587?term=acute+lymphoblastic+leukemia+wieduwilt&rank=1, http://www.pharmoutsourcing.com/Featured-Articles/150621-Key-Strategies-for-Effective-Globalization-of-Clinical-Trials/, https://www.ucdmc.ucdavis.edu/biorepositories/pdfs/misc-biobank/Top-considerations-for-using-social-media-in-research.pdf, www.fda.gov/regulatoryinformation/guidances/ucm126428.htm, http://oig.hhs.gov/oei/reports/oei-01-97-00198.pdf, http://www.inventivhealth.com/docs/e-Recruiting_Using_Digital_Platforms_Social_Media_and_Mobile_Technologies_to_Improve_Clinical_Trial_Enrollment.pdf, http://www.hhs.gov/ohrp/humansubjects/commonrule/, Venous Thromboembolism Prophylaxis and Treatment in Patients With Cancer: ASCO Clinical Practice Guideline Update, Management of Immune-Related Adverse Events in Patients Treated With Immune Checkpoint Inhibitor Therapy: American Society of Clinical Oncology Clinical Practice Guideline, Prognostic Index for Acute- and Lymphoma-Type Adult T-Cell Leukemia/Lymphoma, Reasons to Reject Physician Assisted Suicide/Physician Aid in Dying, Abemaciclib Combined With Endocrine Therapy for the Adjuvant Treatment of HR+, HER2−, Node-Positive, High-Risk, Early Breast Cancer (monarchE), Integration of Palliative Care Into Standard Oncology Care: American Society of Clinical Oncology Clinical Practice Guideline Update, Patient-Clinician Communication: American Society of Clinical Oncology Consensus Guideline, Updating the American Society of Clinical Oncology Value Framework: Revisions and Reflections in Response to Comments Received, American Society of Clinical Oncology Statement: A Conceptual Framework to Assess the Value of Cancer Treatment Options, Symptom Monitoring With Patient-Reported Outcomes During Routine Cancer Treatment: A Randomized Controlled Trial. Accrual proportion (%) was estimated from cancer incidence in SEER 9, SEER 13, and SEER 18 regions and population data from the U.S. Census Bureau.73,75-77. METHODS: The NCI Clinical Trial Cooperative Group surgical oncology trials database was queried for breast, colorectal, lung, and prostate cancers treated during the period 2000-2002 (n=13,991). 2021 Jan 9. doi: 10.1245/s10434-020-09533-z. Evidence as to the association of race with trial participation is mixed. Yet few adults with cancer participate in trials, with typical estimates around 5%, 1 even though most patients express a willingness to participate.