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  1. Article ; Online: Incorporating the patient's voice in the continuum of care.

    Hirsch, Bradford R / Abernethy, Amy P

    Journal of the National Comprehensive Cancer Network : JNCCN

    2013  Volume 11, Issue 1, Page(s) 116–118

    MeSH term(s) Communication ; Humans ; Neoplasms/therapy ; Patient Satisfaction ; Physician-Patient Relations ; Self Report ; Treatment Outcome
    Language English
    Publishing date 2013-01-04
    Publishing country United States
    Document type Journal Article
    ZDB-ID 2250759-0
    ISSN 1540-1413 ; 1540-1405
    ISSN (online) 1540-1413
    ISSN 1540-1405
    DOI 10.6004/jnccn.2013.0014
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  2. Article ; Online: Biosimilars: a cure to the U.S. health care cost conundrum?

    Hirsch, Bradford R / Lyman, Gary H

    Blood reviews

    2014  Volume 28, Issue 6, Page(s) 263–268

    Abstract: As the cost of healthcare continues to rise and patents on biologics near expiration, biosimilars are gaining visibility as a mechanism for cost reduction. Yet, the introduction of biosimilars into the U.S. market will be complex, due to the related ... ...

    Abstract As the cost of healthcare continues to rise and patents on biologics near expiration, biosimilars are gaining visibility as a mechanism for cost reduction. Yet, the introduction of biosimilars into the U.S. market will be complex, due to the related complexity of production, research requirements, and regulatory uncertainty. The purpose of this paper is to frame the relevant issues in order to provide context for stakeholders. It is particularly crucial that clinicians understand the scientific, regulatory, legislative and economic considerations involved in order to ensure that the path to approval is consistent with their needs and that appropriate utilization occurs, once approved.
    MeSH term(s) Biosimilar Pharmaceuticals/economics ; Health Care Costs ; Humans ; United States
    Chemical Substances Biosimilar Pharmaceuticals
    Language English
    Publishing date 2014-11
    Publishing country England
    Document type Journal Article ; Review
    ZDB-ID 639015-8
    ISSN 1532-1681 ; 0268-960X
    ISSN (online) 1532-1681
    ISSN 0268-960X
    DOI 10.1016/j.blre.2014.08.003
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  3. Article ; Online: Comparative effectiveness research: moving medical oncology forward.

    Hirsch, Bradford R / Zafar, S Yousuf

    Seminars in radiation oncology

    2014  Volume 24, Issue 1, Page(s) 49–53

    Abstract: Comparative effectiveness research (CER) is critically needed in medical oncology to improve the care being delivered to oncology patients. As medical oncologists are forced to rely on insufficient data as a part of daily treatment decision making, and ... ...

    Abstract Comparative effectiveness research (CER) is critically needed in medical oncology to improve the care being delivered to oncology patients. As medical oncologists are forced to rely on insufficient data as a part of daily treatment decision making, and as the cancer treatment landscape evolves quickly relative to other areas of medicine, CER is particularly pressing in our field. Continued reliance on randomized clinical trials is a part of the solution, but it cannot be the sole answer. As new and richer data sources become available addressing quality of life, resource utilization, and other critical elements, the implementation of CER will advance. Its true power will lie in linkages to "learning health systems" and real-time application to the day-to-day practice of medicine.
    MeSH term(s) Clinical Trials as Topic/methods ; Comparative Effectiveness Research/methods ; Cost-Benefit Analysis ; Decision Support Techniques ; Humans ; Medical Oncology/methods ; Neoplasms/therapy
    Language English
    Publishing date 2014-01
    Publishing country United States
    Document type Journal Article ; Research Support, Non-U.S. Gov't ; Review
    ZDB-ID 1146999-7
    ISSN 1532-9461 ; 1053-4296
    ISSN (online) 1532-9461
    ISSN 1053-4296
    DOI 10.1016/j.semradonc.2013.08.005
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  4. Article ; Online: The economics of new drugs: can we afford to make progress in a common disease?

    Hirsch, Bradford R / Schulman, Kevin A

    American Society of Clinical Oncology educational book. American Society of Clinical Oncology. Annual Meeting

    2013  

    Abstract: The concept of personalized medicine is beginning to come to fruition, but the cost of drug development is untenable today. To identify new initiatives that would support a more sustainable business model, the economics of drug development are analyzed, ... ...

    Abstract The concept of personalized medicine is beginning to come to fruition, but the cost of drug development is untenable today. To identify new initiatives that would support a more sustainable business model, the economics of drug development are analyzed, including the cost of drug development, cost of capital, target market size, returns to innovators at the product and firm levels, and, finally, product pricing. We argue that a quick fix is not available. Instead, a rethinking of the entire pharmaceutical development process is needed from the way that clinical trials are conducted, to the role of biomarkers in segmenting markets, to the use of grant support, and conditional approval to decrease the cost of capital. In aggregate, the opportunities abound.
    MeSH term(s) Animals ; Commerce/economics ; Cost-Benefit Analysis ; Diffusion of Innovation ; Drug Costs ; Drug Discovery/economics ; Drug Industry/economics ; Humans ; Marketing of Health Services/economics ; Precision Medicine/economics
    Language English
    Publishing date 2013-03-28
    Publishing country United States
    Document type Journal Article ; Research Support, Non-U.S. Gov't ; Review ; Video-Audio Media
    ZDB-ID 2431126-1
    ISSN 1548-8756 ; 1548-8748
    ISSN (online) 1548-8756
    ISSN 1548-8748
    DOI 10.1200/EdBook_AM.2013.33.e126
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  5. Article ; Online: Experience of the National Cancer Institute Community Cancer Centers Program on Community-Based Cancer Clinical Trials Activity.

    Hirsch, Bradford R / Locke, Susan C / Abernethy, Amy P

    Journal of oncology practice

    2016  Volume 12, Issue 4, Page(s) e350–8

    Abstract: Purpose: A goal of the National Cancer Institute Community Cancer Centers Program (NCCCP) was to improve cancer research capacity in community settings. We examined research capacity development during the pilot phase of the NCCCP within the context of ... ...

    Abstract Purpose: A goal of the National Cancer Institute Community Cancer Centers Program (NCCCP) was to improve cancer research capacity in community settings. We examined research capacity development during the pilot phase of the NCCCP within the context of national trends in clinical trial activity with respect to the number and phase of trials, total accrual, and accrual of underserved populations.
    Materials and methods: We examined self-reported data from NCCCP sites during 2007 to 2010, supplemented with data from the National Cancer Institute Cancer Therapy Evaluation Program.
    Results: Trial availability and accrual improved more quickly at NCCCP sites compared with national trends. Phase III trial availability increased 8% nationally versus 16% across NCCCP sites, and accrual increased 30% nationally versus 133% across NCCCP sites. Accrual of racial and ethnic minorities rose 82%, from 83 to 151 patients, and accrual of patients age ≥ 65 years rose by 221%, from 200 to 641 patients. Change in trial portfolio and accrual differed by sophistication of the site and by prior experience in conducting clinical trials at the site.
    Conclusion: Despite the short duration, the NCCCP pilot resulted in an increase in the number of open trials as well as patient accrual at a faster rate than that observed nationally. These results, coupled with insights into the relative success of sites with varying sophistication at the outset, provide promise that lessons learned can be applied more broadly to increase research participation.
    MeSH term(s) Cancer Care Facilities ; Clinical Trials as Topic ; Community Health Services ; Databases, Factual ; Humans ; Medical Oncology ; National Cancer Institute (U.S.) ; Research ; United States
    Language English
    Publishing date 2016-04
    Publishing country United States
    Document type Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
    ZDB-ID 2236338-5
    ISSN 1935-469X ; 1554-7477
    ISSN (online) 1935-469X
    ISSN 1554-7477
    DOI 10.1200/JOP.2015.005090
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  6. Article ; Online: Will biosimilars gain momentum?

    Hirsch, Bradford R / Lyman, Gary H

    Journal of the National Comprehensive Cancer Network : JNCCN

    2013  Volume 11, Issue 10, Page(s) 1291–1297

    Abstract: Biosimilars, also known as follow-on biologics, continue to be an area of great interest in oncology because of the potential cost savings and improved access related to their use, yet significant confusion remains regarding their introduction in the ... ...

    Abstract Biosimilars, also known as follow-on biologics, continue to be an area of great interest in oncology because of the potential cost savings and improved access related to their use, yet significant confusion remains regarding their introduction in the United States. The regulatory and legal hurdles remain poorly defined, and companies producing branded products have been battling their introduction. The European Union provided a pathway for approval in 2004, with various agents reaching the market since that time. It is important to understand the nuances of the discussion and experiences and for clinicians and policy makers to take an active part in defining the role of biosimilars. Several outstanding questions remain, including the degree to which physiochemical, biologic, quality, and clinical end points must be demonstrated in clinical trials compared with the use of analytic data for approval; whether off-label indications should be embraced; and the regulatory rules around areas such as marketing and interchangeability. This article highlights tbo-filgrastim, an agent currently marketed as a biosimilar in Europe, because its pending introduction in the US market provides insights into the potential of these agents.
    MeSH term(s) Biosimilar Pharmaceuticals/therapeutic use ; Drug Approval/legislation & jurisprudence ; Europe ; Filgrastim ; Granulocyte Colony-Stimulating Factor/therapeutic use ; Humans ; Neoplasms/drug therapy ; Recombinant Proteins/therapeutic use ; United States
    Chemical Substances Biosimilar Pharmaceuticals ; Recombinant Proteins ; Granulocyte Colony-Stimulating Factor (143011-72-7) ; Filgrastim (PVI5M0M1GW)
    Language English
    Publishing date 2013-10-15
    Publishing country United States
    Document type Journal Article ; Review
    ZDB-ID 2250759-0
    ISSN 1540-1413 ; 1540-1405
    ISSN (online) 1540-1413
    ISSN 1540-1405
    DOI 10.6004/jnccn.2013.0149
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  7. Article: Leveraging informatics, mobile health technologies and biobanks to treat each patient right.

    Hirsch, Bradford R / Abernethy, Amy P

    Personalized medicine

    2012  Volume 9, Issue 8, Page(s) 849–857

    Abstract: Personalized medicine is the future of clinical care. Many interpret this to mean that advances in genomic medicine will revolutionize care. However, the reality is much more complex, relying on a combination of health technology, patient engagement, ... ...

    Abstract Personalized medicine is the future of clinical care. Many interpret this to mean that advances in genomic medicine will revolutionize care. However, the reality is much more complex, relying on a combination of health technology, patient engagement, genomics, basic sciences and decision-support tools to move the field forward. There are a number of instances in which providers and researchers have already made significant progress toward the goal, yet the advances often occur in isolation and are not widely acknowledged. With appropriate investment, coordination and vision, the present state can be leveraged to change our approach to a given patient within the next few years. Here we demonstrate how currently available informatics, mobile health technology and biobanking solutions can support personalization of care in the near term, and lead to the development of a learning health system.
    Language English
    Publishing date 2012-11
    Publishing country England
    Document type Journal Article
    ZDB-ID 2299146-3
    ISSN 1744-828X ; 1741-0541
    ISSN (online) 1744-828X
    ISSN 1741-0541
    DOI 10.2217/pme.12.102
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  8. Article: Structured decision-making: using personalized medicine to improve the value of cancer care.

    Hirsch, Bradford R / Abernethy, Amy P

    Journal of personalized medicine

    2012  Volume 3, Issue 1, Page(s) 1–13

    Abstract: Cancer care is often inconsistently delivered with inadequate incorporation of patient values and objective evidence into decision-making. Utilization of time limited trials of care with predefined decision points that are based on iteratively updated ... ...

    Abstract Cancer care is often inconsistently delivered with inadequate incorporation of patient values and objective evidence into decision-making. Utilization of time limited trials of care with predefined decision points that are based on iteratively updated best evidence, tools that inform providers about a patient's experience and values, and known information about a patient's disease will allow superior matched care to be delivered. Personalized medicine does not merely refer to the incorporation of genetic information into clinical care, it involves utilization of the wide array of data points relevant to care, many of which are readily available at the bedside today. By pushing uptake of personalized matching available today, clinicians can better address the triple aim of improved health, lowers costs, and enhanced patient experience, and we can prepare the health care landscape for the iterative inclusion of progressively more sophisticated information as newer tests and information become available to support the personalized medicine paradigm.
    Language English
    Publishing date 2012-12-27
    Publishing country Switzerland
    Document type Journal Article ; Review
    ZDB-ID 2662248-8
    ISSN 2075-4426
    ISSN 2075-4426
    DOI 10.3390/jpm3010001
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  9. Article ; Online: Pharmacoeconomics of the myeloid growth factors: a critical and systematic review.

    Hirsch, Bradford R / Lyman, Gary H

    PharmacoEconomics

    2012  Volume 30, Issue 6, Page(s) 497–511

    Abstract: Background: The pharmacoeconomics of the myeloid growth factors (MGFs) is an important topic that has received substantial attention in recent years. The use of the MGFs as primary prophylaxis to prevent febrile neutropenia (FN) has grown considerably ... ...

    Abstract Background: The pharmacoeconomics of the myeloid growth factors (MGFs) is an important topic that has received substantial attention in recent years. The use of the MGFs as primary prophylaxis to prevent febrile neutropenia (FN) has grown considerably over the past decade and professional guidelines regarding their use have broadened the settings in which these agents are indicated. Recent data also suggest a potential role for them in reducing infection-related and all-cause mortality. The cost and effectiveness of these agents will continue to gain visibility as companies pursue approval for biosimilar agents in the US, similar to their recent approval in Europe.
    Objectives: The objective of this paper is to review the available pharmacoeconomic literature on the MGFs, which is particularly timely in light of the recent passage of healthcare reform and the increasing focus on cost control. The cost of treating cancer in the US is rising faster than the already rapid increase in overall medical expenditure. The clinical utility and cost effectiveness of supportive care measures in oncology must therefore be weighed carefully. This review focuses on the use of different formulations of MGFs for primary and secondary prophylaxis of chemotherapy-induced neutropenia.
    Methods: A MEDLINE search was performed to find studies that became available since the prior review of this topic was published in Pharmacoeconomics in 2003.
    Results: Acceptable cost-minimization estimates for primary prophylaxis with the MGFs in patients receiving cancer chemotherapy have been provided by several studies in the US. Of the commonly used agents in the US, pegfilgrastim appears to be superior to the currently recommended dose and schedule of filgrastim in terms of cost minimization, and primary prophylaxis appears to be less costly than secondary prophylaxis. However, the cost benefits of primary prophylaxis in Europe are not as pronounced as in the US, due to the lower costs of medical care. Data continue to emerge suggesting a decreased risk of early mortality from averted infections as well as the possibility of a disease-specific mortality benefit through maintaining the relative dose intensity of chemotherapy with MGF support.
    Conclusion: This evidence will prove valuable in assessing the overall cost effectiveness and cost utility of the MGFs in patients receiving cancer chemotherapy.
    MeSH term(s) Antineoplastic Agents/adverse effects ; Antineoplastic Agents/therapeutic use ; Biosimilar Pharmaceuticals/economics ; Biosimilar Pharmaceuticals/therapeutic use ; Cost-Benefit Analysis ; Drug Costs ; Economics, Pharmaceutical ; Europe ; Fever/chemically induced ; Fever/economics ; Fever/prevention & control ; Granulocyte Colony-Stimulating Factor/economics ; Granulocyte Colony-Stimulating Factor/therapeutic use ; Granulocyte-Macrophage Colony-Stimulating Factor/economics ; Granulocyte-Macrophage Colony-Stimulating Factor/therapeutic use ; Humans ; Neoplasms/drug therapy ; Neutropenia/chemically induced ; Neutropenia/economics ; Neutropenia/prevention & control ; United States
    Chemical Substances Antineoplastic Agents ; Biosimilar Pharmaceuticals ; Granulocyte Colony-Stimulating Factor (143011-72-7) ; Granulocyte-Macrophage Colony-Stimulating Factor (83869-56-1)
    Language English
    Publishing date 2012-04-27
    Publishing country New Zealand
    Document type Journal Article ; Review ; Systematic Review
    ZDB-ID 1100273-6
    ISSN 1179-2027 ; 1170-7690
    ISSN (online) 1179-2027
    ISSN 1170-7690
    DOI 10.2165/11590130-000000000-00000
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    Zs.A 3579: Show issues Location:
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  10. Article: Treatment selection in metastatic renal cell carcinoma: more confusion or a path forward?

    Hirsch, Bradford R / George, Daniel J / Harrison, Michael R

    Clinical advances in hematology & oncology : H&O

    2014  Volume 12, Issue 3, Page(s) 163–171

    Abstract: Meaningful progress has been realized in the treatment of metastatic renal cell carcinoma with the recent approval of a number of new agents; more new agents are on the horizon. Despite the recent completion of many clinical trials that have changed or ... ...

    Abstract Meaningful progress has been realized in the treatment of metastatic renal cell carcinoma with the recent approval of a number of new agents; more new agents are on the horizon. Despite the recent completion of many clinical trials that have changed or will change practice, many questions remain. In this manuscript, we highlight the most noteworthy developments in the first- and second-line treatment of metastatic renal cell carcinoma, as these are the areas of greatest change. We also emphasize ongoing trials and those areas that are most in need of study in order to move the field forward. Although more data are needed, exciting progress is being made.
    MeSH term(s) Antineoplastic Agents/administration & dosage ; Antineoplastic Agents/therapeutic use ; Antineoplastic Combined Chemotherapy Protocols/therapeutic use ; Carcinoma, Renal Cell/mortality ; Carcinoma, Renal Cell/pathology ; Carcinoma, Renal Cell/therapy ; Clinical Trials as Topic ; Humans ; Kidney Neoplasms/pathology ; Kidney Neoplasms/therapy ; Molecular Targeted Therapy ; Neoplasm Metastasis ; Retreatment ; Standard of Care ; Treatment Failure ; Treatment Outcome
    Chemical Substances Antineoplastic Agents
    Language English
    Publishing date 2014-03
    Publishing country United States
    Document type Journal Article ; Review
    ZDB-ID 2271951-9
    ISSN 1543-0790
    ISSN 1543-0790
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