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Cottler L.B.,University of Florida | McCloskey D.J.,U.S. National Institutes of Health | Aguilar-Gaxiola S.,University of California at Davis | Bennett N.M.,University of Rochester | And 8 more authors.
American Journal of Public Health | Year: 2013

Objectives. We used results generated from the first study of the National Institutes of Health Sentinel Network to understand health concerns and perceptions of research among underrepresented groups such as women, the elderly, racial/ethnic groups, and rural populations. Methods. Investigators at 5 Sentinel Network sites and 2 community-focused national organizations developed a common assessment tool used by community health workers to assess research perceptions, health concerns, and conditions. Results. Among 5979 individuals assessed, the top 5 health concerns were hypertension, diabetes, cancer, weight, and heart problems; hypertension was the most common self-reported condition. Levels of interest in research participation ranged from 70.1% among those in the "other" racial/ethnic category to 91.0% among African Americans. Overall, African Americans were more likely than members of other racial/ethnic groups to be interested in studies requiring blood samples (82.6%), genetic samples (76.9%), or medical records (77.2%); staying overnight in a hospital (70.5%); and use of medical equipment (75.4%). Conclusions. Top health concerns were consistent across geographic areas. African Americans reported more willingness to participate in research even if it required blood samples or genetic testing.

Harris L.N.,Case Western Reserve University | Ismaila N.,American Society of Clinical Oncology | McShane L.M.,U.S. National Cancer Institute | Andre F.,Institute Gustave Roussy | And 10 more authors.
Journal of Clinical Oncology | Year: 2016

Purpose: To provide recommendations on appropriate use of breast tumor biomarker assay results to guide decisions on adjuvant systemic therapy for women with early-stage invasive breast cancer. Methods: A literature search and prospectively defined study selection sought systematic reviews, metaanalyses, randomized controlled trials, prospective-retrospective studies, and prospective comparative observational studies published from 2006 through 2014. Outcomes of interest included overall survival and disease-free or recurrence-free survival. Expert panel members used informal consensus to develop evidence-based guideline recommendations. Results: The literature search identified 50 relevant studies. One randomized clinical trial and 18 prospectiveretrospective studies were found to have evaluated the clinical utility, as defined by the guideline, of specific biomarkers for guiding decisions on the need for adjuvant systemic therapy. No studies that met guideline criteria for clinical utility were found to guide choice of specific treatments or regimens. Recommendations: In addition to estrogen and progesterone receptors and human epidermal growth factor receptor 2, the panel found sufficient evidence of clinical utility for the biomarker assays Oncotype DX, EndoPredict, PAM50, Breast Cancer Index, and urokinase plasminogen activator and plasminogen activator inhibitor type 1 in specific subgroups of breast cancer. No biomarker except for estrogen receptor, progesterone receptor, and human epidermal growth factor receptor 2 was found to guide choices of specific treatment regimens. Treatment decisions should also consider disease stage, comorbidities, and patient preferences. © 2016 by American Society of Clinical Oncology.

Katz M.L.,Ohio State University | Archer L.E.,Duke University | Peppercorn J.M.,Duke University | Kereakoglow S.,Dana-Farber Cancer Institute | And 4 more authors.
Cancer | Year: 2012

BACKGROUND: Patient advocates are increasingly involved in cooperative group trials, single-institution cancer programs, and peer-review of research applications. The purpose of this study was to evaluate the role and value of patient advocates from the perspective of Cancer and Leukemia Group B (CALGB) advocates and investigators. METHODS: An online survey was sent to current and past (within 5 years) patient advocates and investigators. RESULTS. Response rates were 72.7% (16 of 22) for advocates and 56.4% (102 of 181) for investigators. Patient advocates were more likely than investigators to report the following: the clinical trial process benefited from advocate involvement on committees (100% of advocates vs 72.1% of investigators; P <.05), advocates contribute to protocol development (92.8% vs 33.8%, respectively; P <.001), the cultural appropriateness of protocols (21.4% vs 10.4%, respectively; P <.05), advocates assist with patient accrual (78.6% vs 23.4%, respectively; P <.001), and advocates add value to concept development and protocol review (100% vs 63.2%, respectively; P <.001). Over half of advocates and investigators reported gaps in patient advocate knowledge and suggested that additional clinical trials training was needed. To improve clinical trials, advocates suggested their earlier involvement in protocol development and increased support from investigators. CALGB investigators recommended improving patient advocate selection and communication skills training: CONCLUSIONS: The majority of patient advocates and investigators perceived benefits from advocate involvement in the clinical trials process; patient advocates placed more value on their role than investigators. The current results indicated that strategies to improve advocacy training and advocate-investigator communication may further enhance the role of patient advocates, and future studies that clarify the role of advocates in the prioritization and development of protocol, consent, and education materials, and on patient accrual, are warranted. © 2012 American Cancer Society.

Paller C.J.,Johns Hopkins Hospital | Bradbury P.A.,Queens University | Ivy S.P.,U.S. National Cancer Institute | Seymour L.,Queens University | And 12 more authors.
Clinical Cancer Research | Year: 2014

Anticancer drugs are combined in an effort to treat a heterogeneous tumor or to maximize the pharmacodynamic effect. The development of combination regimens, while desirable, poses unique challenges. These include the selection of agents for combination therapy that may lead to improved efficacy while maintaining acceptable toxicity, the design of clinical trials that provide informative results for individual agents and combinations, and logistic and regulatory challenges. The phase I trial is often the initial step in the clinical evaluation of a combination regimen. In view of the importance of combination regimens and the challenges associated with developing them, the Clinical Trial Design (CTD) Task Force of the National Cancer Institute Investigational Drug Steering Committee developed a set of recommendations for the phase I development of a combination regimen. The first two recommendations focus on the scientific rationale and development plans for the combination regimen; subsequent recommendations encompass clinical design aspects. The CTD Task Force recommends that selection of the proposed regimens be based on a biologic or pharmacologic rationale supported by clinical and/or robust and validated preclinical evidence, and accompanied by a plan for subsequent development of the combination. The design of the phase I clinical trial should take into consideration the potential pharmacokinetic and pharmacodynamic interactions as well as overlapping toxicity. Depending on the specific hypothesized interaction, the primary endpoint may be dose optimization, pharmacokinetics, and/or pharmacodynamics (i.e., biomarker). ©2014 American Association for Cancer Research.

Peppercorn J.,Duke University | Shapira I.,Hofstra University | Deshields T.,Barnes Jewish Hospital | Kroetz D.,University of California at San Francisco | And 6 more authors.
Cancer | Year: 2012

BACKGROUND: The rapid pace of genetics research, coupled with evolving standards for informed consent, can create ethical challenges regarding future use of tissue or information from completed clinical trials. The Cancer and Leukemia Group B (CALGB) Oncology Cooperative Group was faced with an ethical dilemma regarding sharing genetic data from a completed genome-wide association study (GWAS) that was conducted as part of a large, multicenter breast cancer clinical trial with a national database: the Database of Genotypes and Phenotypes National Center for Biotechnology Information (dbGaP). METHODS: The CALGB Ethics Committee conducted a series of multidisciplinary meetings and teleconferences involving patient advocates, bioethicists, clinical researchers, and clinical oncologists to evaluate the ethical issues raised by this case and to identify lessons for improving informed consent to future genetics research in oncology trials. RESULTS: The Ethics Committee recommended that GWAS data be provided to dbGaP consistent with documented consent for future use of tissue among trial participants. Ethical issues, including adequacy of informed consent to future research, limitations of privacy in modern genetics research, the potential impact of population-based genetics research on health disparities, and recontact of research participants for clinical care or further research, were identified as major ethical considerations in this area. CONCLUSIONS: Although modern standards for informed consent should not prohibit research or sharing of data consistent with participant's intent and the public interest, there is an urgent need for national consensus on the appropriate use of archived tissue and standardized informed consent for future research among cancer clinical trial participants. Copyright © 2012 American Cancer Society.

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