ASCO Daily News 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. 10.Pishvaian MJ, Blais EM, Brody JR, et al. Clinical trials are the key step in advancing new treatments from the research setting to the cancer care clinic. The remaining patients are sometimes not offered the chance to participate because of physician concerns, or decline due to patient concerns. Kohler BA, Sherman RL, Howlader N, et al. We have shown data indicating a compelling relationship between the incidence of clinical trial enrollments and improvements in cancer population survival outcomes. Gross CP, Filardo G, Mayne ST, Krumholz HM. The principle of equipoise posits that a properly designed treatment trial tests a new or modified form of therapy that is not known to have that benefit (otherwise the trial would not be justified). The predominant reason that trials fail to complete is poor accrual.126 These failures represent a lost investment on the part of funding agencies. For time-to-event data, the Kaplan-Meier method will be used. Our focus was a natural observational contrast between AYAs and other age groups with cancer. 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. Data source is SEER 9 regions.75. InVentiv Health Clinical Division. Kantor O, Chang C, Yao K, Boughey J, Roland C, Francescatti AB, Blair S, Dickson Witmer D, Hunt KK, Nelson H, Weiss A, Oseni T. Ann Surg Oncol. 2013;31:15s (suppl; abstr 7500). Provide a summary statement regarding the intended uses of the social media account. Finally, we examine global and local strategies to improve cancer clinical trial participation. Although developing local resources provides an often needed benefit, this could involve higher costs and may also be deterred by local shipping laws and other logistic barriers. Clinical trial accrual to cancer case ratios were evaluated using a database of residents at the continental United States seen at The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins from 2005 to 2007. A promising tool to foster informed consent. Wendler D, Kington R, Madans J, Van Wye G, Christ-Schmidt H, Pratt LA, Brawley OW, Gross CP, Emanuel E. PLoS Med. The more rapid completion of trials would enable new treatments to be developed more quickly. These additional funds were most commonly used to provide additional staff time for minority recruitment. Epub 2019 Mar 1. The literature indicates that structural barriers preclude patient participation in trials for half of all cancer patients. Version 4.1.1. Incorporate error reduction strategies and consider regional variations in the standards of care and their effect on trial results. 5). All patients were offered treatment with surgery/chemotherapy and were screened at diagnosis for participation in clinical research. This research studies factors affecting Chinese patient participation in cancer clinical trials and their knowledge regarding clinical trials. Fewer barriers to trial participation would enable trials to be completed more quickly and would improve the generalizability of trial results. 2007 Dec;14(12):3328-34. doi: 10.1245/s10434-007-9500-y. Objectives: To determine the effect of participation in clinical trials on survival of women with ovarian cancer. Inevitably, the decision about whether to participate in a trial will reflect a patient’s personal preferences, which may also be influenced by family and friends.38, Some proportion of patients are influenced by altruistic motivations.15 However, the majority of patients are (appropriately) concerned primarily with finding the best possible treatment of their disease.15,39,40 In the absence of other barriers, a patient who believes that the best possible treatment option is to be found in a clinical trial is more likely to participate in that clinical trial.33, Patients have frequently reported being uneasy or fearful about the prospect of participating in a clinical trials.41 In some cases this could be due to a residual mistrust of medical science due to past abuses, such as the infamous Tuskegee Syphilis Study or the history of human experimentation with radiation following World War II.42,43 Attention in the last several decades to the process of rigorous consent may have reduced these fears, especially for younger generations of patients. Moreover, when clinical trials close because of failure to accrue, nonfinancial costs are also incurred. Javid et al registered patients to a prospective survey study prior to their treatment decision regarding their cancer care at a diverse set of eight institutions. 2021 Jan 22:1-13. doi: 10.1007/s40487-021-00140-w. Online ahead of print. The greatest effort during the last decade to increase accruals in AYAs was within the population with acute lymphoblastic leukemia (ALL), the most common pediatric cancer. 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. I = Immediate Family Member, Inst = My Institution. Fear of randomization has been identified as the most commonly cited reason by patients for declining trial participation.15 Recognizing this, some physicians avoid the word “randomization,” relying instead on analogy to describe the randomization process, though this may lead to situations where patients sometimes do not understand that their treatment has been randomly assigned.48,49, Patients are sometimes uneasy as well about the potential toxic effects of chemotherapy in trials, especially for the experimental therapies.38 Patients may already have a strong sense of the particular treatment they wish to receive after discussion with their physicians.33 Because trials sometimes require more frequent monitoring than nontrial care, traveling to and from a cancer clinic has been indicated by many patients to be a reason for nonparticipation.15,20 Concern about how to pay for trials has been cited as a reason for nonparticipation among about a quarter of patients, despite the fact that the majority of states mandate that insurers cover the routine care costs of trials, as does Medicare.15 In a review by Ford et al, cost concerns were identified as the second most frequently indicated reason for nonparticipation in trials in the literature.41, Demographic and socioeconomic disparities in trial enrollment can occur anywhere along the pathway from initial clinic visit until the patient ultimately makes their treatment decision. Crit Care Med. Design, setting, and patients: Recognizing this, in 2000, Medicare was directed to cover the routine care costs of clinical trial participation for its patients.59 Unfortunately, the proportion of older patients in trials remains well below the expected rate.28,51. This model has been the basis for multiple studies examining barriers to clinical trial participation.13-15 The model indicates that after cancer diagnosis and a clinic visit, an assessment of trial availability is made to identify whether a trial exists at the institution for the patient’s histology and stage. Chen MS Jr, Lara PN, Dang JH, Paterniti DA, Kelly K. Cancer. Research staff received START education, and recruitment tools including motivational videos. American Cancer Society. Cancer Treatment and Survivorship Facts & Figures 2014-2015. Summary recommendations centered on the patient, community, physician/provider, and site.97 This symposium led to many recommendations at each level consistent with the overarching view that one size does not fit all when it comes to recruitment to clinical trials. These data are consistent with the idea that a clinical trial system that enrolls patients at a higher rate produces treatment advances at a faster rate, and concurrent survival increases and mortality reductions in the cancer population. Although the total number of trial participants increased during our study period, the representation of racial and ethnic minorities decreased. NLM As suggested above, these age-proximal patient groups provide a natural observational contrast illuminating the association between clinical trial enrollment rates and corresponding improvements in outcomes in the cancer population. Information and communication in the context of a clinical trial, Underrepresentation of patients 65 years of age or older in cancer-treatment trials, Participation of patients 65 years of age or older in cancer clinical trials, Enrollment of elderly patients in clinical trials for cancer drug registration: a 7-year experience by the US Food and Drug Administration, Impact of the year 2000 Medicare policy change on older patient enrollment to cancer clinical trials, Barriers to clinical trial participation by older women with breast cancer, Survey of oncologists’ perceptions of barriers to accrual of older patients with breast carcinoma to clinical trials, Systematic review of barriers to the recruitment of older patients with cancer onto clinical trials, The National Institute on Aging and the National Cancer Institute SEER collaborative study on comorbidity and early diagnosis of cancer in the elderly, Cancer burden in the aged: an epidemiologic and demographic overview, Participation in surgical oncology clinical trials: gender-, race/ethnicity-, and age-based disparities, The impact of socioeconomic status and race on trial participation for older women with breast cancer, Minority recruitment to the Selenium and Vitamin E Cancer Prevention Trial (SELECT), Impact of supplemental site grants to increase African American accrual for the Selenium and Vitamin E Cancer Prevention Trial, Special populations recruitment for the Women’s Health Initiative: successes and limitations, Minority recruitment in the prostate cancer prevention trial, Patient income level and cancer clinical trial participation: a prospective survey study, Incremental treatment costs in national cancer institute-sponsored clinical trials, Potential favorable impact of the affordable care act of 2010 on cancer in young adults in the United States, The distinctive biology of cancer in adolescents and young adults, Adolescents and young adults with cancer: what will it take to improve outcome, Delays in cancer diagnosis in underinsured young adults and older adolescents, Intergroup Trial C10403: a pediatric treatment approach to improve outcomes in adolescents and young adults with acute lymphoblastic leukemia, Long-term outcome of a pediatric-inspired regimen used for adults aged 18-50 years with newly diagnosed acute lymphoblastic leukemia, How NCCN guidelines can help young adults and older adolescents with cancer and the professionals who care for them, Pediatric-like therapy for adults with ALL, Treatment outcome in young adults and children >10 years of age with acute lymphoblastic leukemia in Sweden: a comparison between a pediatric protocol and an adult protocol, Markedly improved outcomes and acceptable toxicity in adolescents and young adults with acute lymphoblastic leukemia following treatment with a pediatric protocol: a phase II study by the Japan Adult Leukemia Study Group, Excellent outcomes for adolescents and adults with acute lymphoblastic leukemia and lymphoma without allogeneic stem cell transplant: the FRALLE-93 pediatric protocol, Adolescents and young adults with acute lymphoblastic leukemia have a better outcome when treated with pediatric-inspired regimens: systematic review and meta-analysis, Comparison of the results of the treatment of adolescents and young adults with standard-risk acute lymphoblastic leukemia with the Programa Español de Tratamiento en Hematología pediatric-based protocol ALL-96, Acute lymphoblastic leukemia in adolescents and young adults in Finland, What determines the outcomes for adolescents and young adults with acute lymphoblastic leukemia treated on cooperative group protocols? Model Pathway of Trial Enrollment Process. In this context, the issue of clinical trial enrollment is viewed as foundational, lying at the heart of the cancer clinical trial endeavor.12 Therefore, the identification of specific barriers to trial enrollment and efforts to remove such barriers represent critical research objectives for cancer investigators. Our analysis suggests that a clinical trial system that enrolls patients at a higher rate produces treatment advances at a faster rate and corresponding improvements in cancer population outcomes. ASCO Author Services This survey was embedded within an online cancer treatment decision tool that was accessible on many cancer websites such as the American Cancer Society. Patients age 20 to 24 had a particularly poor reduction in cancer mortality, as well as the lowest absolute number of clinical trial accruals. Mortality data were obtained from the National Center for Health Statistics via the SEER program.78. J Clin Oncol. Also, cancer in AYAs have potentially complex biologic signatures that neither pediatric oncologists nor adult-treating medical and hematologist oncologists are accustomed to treating.70 AYAs are also less likely to have health insurance,71 especially prior to the advent of the Affordable Care Act, which could be associated with delays in diagnosis and compromises in optimum diagnostic and therapeutic interventions.72 At the same time, AYAs have had the lowest participation in clinical trials in absolute terms than any other major age group.10 The central issue then is the extent to which lack of clinical trial activity in AYA patients with cancer accounts for the relative lack of progress in improving cancer population outcomes. Viewed in this light, the issue of clinical trial enrollment is foundational, lying at the heart of the cancer clinical trial endeavor. Howlader N, Noone AM, Krapcho M, et al (eds). April 2015. 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. Second, the dependency of survival prolongation on treatment trial accrual has been apparent for all ages. A patient’s decision of which cancer treatment to receive is complex and deeply personal; the prospect of incorporating clinical trial treatment into a patient’s care adds another level of complexity. Fortunately, such a system already exists. This “AYA ALL cliff” constituted 30% of the overall decline from 95% at age 5 to less than 20% at age 70. However, the ultimate decision regarding trial participation rests with the patient. 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. Survival data were obtained from SEER 9 Regions.75 Kaposi sarcoma is excluded from the survival statistic because the HIV/AIDS epidemic occurred during the 1980s and early 1990s, which substantively altered the overall cancer survival rate in AYAs during those years. An excellent example of global recruitment is the START trial.101 START is a multicenter, phase III, randomized, double-blind, placebo-controlled trial of the cancer vaccine tecemotide in patients with non-small cell lung cancer with unresectable stage III disease. Therefore, a thorough understanding of the nature of trial enrollment patterns and barriers to enrollment is of paramount importance. Joinpoint analysis identified two inflections, ages 17 and 20, during which the 5-year survival rate decreased 23%. 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. J Adv Pract Oncol. 185-198. 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. ASCO Meetings Age-, sex-, and race-based differences among patients enrolled versus not enrolled in acute lung injury clinical trials. A survey of oncologists in community cancer clinics found that most agreed that clinical trials provide high-quality care (87%) and benefit enrolled patients (83%).30 However, physicians face their own barriers to trial enrollment, so even if quality cancer care is assumed, physicians may treat otherwise eligible patients off-protocol with one arm of a trial, without actually entering the patient on the trial.31 Multiple earlier studies found physician decision or preference was the primary reason for nonparticipation in half of the patients for whom a protocol was available and the patient was eligible.21,22. Annual Report to the Nation on the status of cancer, 1975-2011, featuring incidence of breast cancer subtypes by race/ethnicity, poverty, and state. In 2010, the NCI and the American Society of Clinical Oncology sponsored a Cancer Trial Accrual Symposium to provide recommendations for trial recruitment. 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. It is recognized that there is greater fluidity between these categories than the model allows, but simplifications were made to facilitate discussion. Explain randomised clinical trials have access to a cancer clinic NCI Cooperative Group Program Challenges and:. Trials at minority Serving cancer centers and clinical trial activity decision about whether to participate trials., Blais EM, Brody JR, Lara PN, Dang JH, Paterniti,. Participation leads to better cancer population outcomes thank you cards and patient START educational teleconferencing 2009 were.... 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