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1.
BMJ ; 367: l5766, 2019 10 23.
Artigo em Inglês | MEDLINE | ID: mdl-31645328

RESUMO

OBJECTIVE: To determine the extent to which late stage development of new drugs relies on support from public funding. DESIGN: Cohort study. SETTING: All new drugs containing one or more new molecular entities approved by the US Food and Drug Administration (FDA) between January 2008 and December 2017 via the new drug application pathway. MAIN OUTCOME MEASURES: Patents or drug development histories documenting late stage research contributions by a public sector research institution or a spin-off company, as well as each drug's regulatory approval pathway and first-in-class designation. RESULTS: Over the 10 year study period, the FDA approved 248 drugs containing one or more new molecular entities. Of these drugs, 48 (19%) had origins in publicly supported research and development and 14 (6%) originated in companies spun off from a publicly supported research program. Drugs in these groups were more likely to receive expedited FDA approval (68% v 47%, P=0.005) or be designated first in class (45% v 26%, P=0.007), indicating therapeutic importance. CONCLUSIONS: A review of the patents associated with new drugs approved over the past decade indicates that publicly supported research had a major role in the late stage development of at least one in four new drugs, either through direct funding of late stage research or through spin-off companies created from public sector research institutions. These findings could have implications for policy makers in determining fair prices and revenue flows for these products.


Assuntos
Ensaios Clínicos como Assunto/economia , Aprovação de Drogas/economia , Setor Público/economia , Pesquisa Médica Translacional/economia , Ensaios Clínicos como Assunto/estatística & dados numéricos , Estudos de Coortes , Aprovação de Drogas/legislação & jurisprudência , Aprovação de Drogas/estatística & dados numéricos , Humanos , Patentes como Assunto/estatística & dados numéricos , Setor Público/estatística & dados numéricos , Pesquisa Médica Translacional/estatística & dados numéricos , Estados Unidos , United States Food and Drug Administration/legislação & jurisprudência , United States Food and Drug Administration/estatística & dados numéricos
3.
Curr Oncol ; 26(4): 272-284, 2019 08.
Artigo em Inglês | MEDLINE | ID: mdl-31548808

RESUMO

Background: A novel way to build capacity in knowledge translation (kt) is through kt-focused grant competitions. Since 2009, the Knowledge Translation Research Network (KT-Net) has had a cancer-related kt grants program. We undertook an evaluation of the program to determine if KT-Net was achieving its aims of building capacity in cancer kt, advancing the science of kt, building partnerships, and leveraging funding. Methods: An adapted framework guided the evaluation. Nine funded studies from 4 competitions were included. Semi-structured telephone interviews were held with researchers, stakeholders (including knowledge users), members of grant review panels, and experts in kt. Interview transcripts were audio-recorded, transcribed, and analyzed thematically. A review of proposal and report documents was also conducted. Results: Funded researchers indicated that the grant competition was an essential funding program for cancer kt research. Competitions were perceived to build capacity in cancer kt among early-career researchers and to encourage innovative cancer kt research for which alternative funding sources are limited. The grants program resulted in incremental gains in advancing the science of kt. Suggestions to improve the program included stronger partnerships between the funder and the provincial cancer-system organization to optimize the application of research that is relevant to the organization's strategic objectives. Conclusions: The grants program met many of its aims by providing cancer researchers with an opportunity to gain capacity in cancer kt and by making incremental advances in kt science. Suggestions to improve the program included closer partnerships between the funder and the cancer-system organization.


Assuntos
Neoplasias/terapia , Pesquisa Médica Translacional/economia , Estudos de Avaliação como Assunto , Humanos , Avaliação de Programas e Projetos de Saúde
4.
Artigo em Inglês | MEDLINE | ID: mdl-31443335

RESUMO

In this special issue of IJERPH, we feature studies conducted by research translation and community engagement teams that are funded through the Superfund Research Program in the United States. These and other teams funded by this program demonstrate how environmental and health communication research can contribute to generalizable lessons about helping and empowering contaminated communities. These types of applied behavioral, social and communication projects are important because while much about our communities is unique and must be addressed on a case by case basis, other aspects of research translation and community engagement processes are potentially generalizable across sites and can thus be used to scale up solutions to toxic contamination to other communities and countries more rapidly than would otherwise occur.


Assuntos
Participação da Comunidade , Saúde Ambiental/organização & administração , Comunicação em Saúde , Pesquisa Médica Translacional , Participação da Comunidade/economia , Pesquisa Médica Translacional/economia , Estados Unidos
5.
Mol Cell Biol ; 39(15)2019 08 01.
Artigo em Inglês | MEDLINE | ID: mdl-31085684

RESUMO

The first nonsurgical cancer therapy was bacterial therapy introduced in 1891 to treat solid tumors. Because in many cases it was harmful and ineffective, and with the emergence of radiotherapy and chemotherapy, bacterial therapy was discontinued. Motivated by the need to improve targeting of solid tumors and in light of recent progress made in developing microbial therapies, the National Cancer Institute has for the first time issued funding opportunities to stimulate research on bacterium-based cancer therapies for conditions under which current cancer therapies are inadequate.


Assuntos
Proteínas de Bactérias/metabolismo , Neoplasias/terapia , Pesquisa Médica Translacional/economia , Bactérias/imunologia , Fenômenos Fisiológicos Bacterianos , Terapia Biológica , Humanos , National Cancer Institute (U.S.) , Neoplasias/imunologia , Estados Unidos
7.
PLoS One ; 14(4): e0214361, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-30970015

RESUMO

Quantifying the value of investment in medical research can inform decision-making on the prioritisation of research programmes. Existing methodologies to estimate the rate of return of medical research are inappropriate for early-phase translational research due to censoring of health benefits and time lags. A strategy to improve the process of translational research for patient benefit has been initiated as part of the UK National Institute for Health Research (NIHR) investment in Biomedical Research Centres (BRCs) in England. By providing a platform for partnership between universities, NHS trusts and industry, successful BRCs should reduce time lags within translational research whilst also providing an impetus for local economic growth through industry collaboration. We present a novel contribution in the assessment of early-phase biomedical research by estimating the impact of the Oxford Biomedical Research Centre (OxBRC) on income and job creation following the initial NIHR investment. We adopt a macroeconomic assessment approach using Input-Output Analysis to estimate the value of medical research in terms of income and job creation during the early pathway towards translational biomedical research. Inter-industry linkages are assessed by building a model economy for the South East England region to estimate the return on investment of the OxBRC. The results from the input-output model estimate that the return on investment in biomedical research within the OxBRC is 46%. Each £1 invested in the OxBRC generates an additional £0.46 through income and job creation alone. Multiplicative employment effects following a marginal investment in the OxBRC of £98m during the period 2007-2017 result in an estimated additional 196 full time equivalent positions being created within the local economy on top of direct employment within OxBRC. Results from input-output analyses can be used to inform the prioritisation of biomedical research programmes when compared against national minimum thresholds of investment.


Assuntos
Pesquisa Biomédica/economia , Análise Custo-Benefício/economia , Gastos em Saúde , Pesquisa Médica Translacional/economia , Humanos , Modelos Econômicos , Anos de Vida Ajustados por Qualidade de Vida , Medicina Estatal/economia , Reino Unido
9.
Therapie ; 74(1): 9-15, 2019 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-30638855

RESUMO

Fifteen years after the completion of first human genome sequencing, the technique is almost a commodity but there is still little evidence of its usefulness as a diagnostic, prognostic or therapeutic tool. In France, the France genomics plan 2025 was launched in 2015 with the goal of integrating genomic tests into clinical practice and developing a National genomics network including industrial partnerships. Reflection on scientific applications and operational or societal issues is needed to make recommendations to help better associate Genomics and the medicine of tomorrow. In the perspective of personalized Evidence-based Medicine, studies with an appropriate methodological level to improve the definition of evidence should be promoted. The many operational challenges require the implementation of organisations and means to streamline the process of results reporting, and regulatory adaptations concerning the status of professions involved, the management of data generated, and the consent of patients. In parallel, genetic training for healthcare professionals and raising awareness on genetic tests for the public should be considered. The ethical stake should also be taken into account, especially on the participation of the patient in decisions concerning them and integrating the notion of uncertainty into the information given. The sociological effects on the experience and expectations of patients and the general population towards genomic medicine should also be evaluated to improve information, prevention and support for people. Finally, medico-economic studies must be conducted to inform policy-makers on the cost-effectiveness of complete genome sequencing for population health.


Assuntos
Genômica , Pesquisa Médica Translacional/tendências , Big Data , Medicina Baseada em Evidências , França , Humanos , Medicina de Precisão/tendências , Pesquisa Médica Translacional/economia , Pesquisa Médica Translacional/ética
10.
Mol Oncol ; 13(3): 636-647, 2019 03.
Artigo em Inglês | MEDLINE | ID: mdl-30628161

RESUMO

Health economics is an integrated aspect of all phases of mission-oriented translational cancer research and should be considered an intrinsic component of any study aimed at improving outcomes for patients and intervention costs. Information about value and value for money of new options for prevention and treatment is needed for decisions about their adoption and use by healthcare systems.


Assuntos
Assistência à Saúde/economia , Neoplasias/economia , Pesquisa Médica Translacional/economia , Antineoplásicos/economia , Antineoplásicos/uso terapêutico , Efeitos Psicossociais da Doença , Análise Custo-Benefício , Humanos , Neoplasias/tratamento farmacológico
11.
Clin Trials ; 16(2): 183-193, 2019 04.
Artigo em Inglês | MEDLINE | ID: mdl-30628466

RESUMO

BACKGROUND: A significant barrier to conducting clinical trials is their high cost, which is driven primarily by the time and resources required to activate trials and reach accrual targets. The high cost of running trials has a substantial impact on their long-term feasibility and the type of clinical research undertaken. METHODS: A scoping review of the empirical literature on the costs associated with conducting clinical trials was undertaken for the years 2001-2015. Five reference databases were consulted to elicit how trials costs are presented in the literature. A review instrument was developed to extract the content of in-scope papers. Findings were characterized by date and place of publication, clinical disease area, and network/cooperative group designation, when specified. Costs were captured and grouped by patient accrual and management, infrastructure, and the opportunity costs associated with industry funding for trials research. Cost impacts on translational research and health systems were also captured, as were recommendations to reduce trial expenditures. Since articles often cited multiple costs, multiple cost coding was used during data extraction to capture the range and frequency of costs. RESULTS: A total of 288 empirical articles were included. The distribution of reported costs was: patient management and accrual costs (132 articles), infrastructure costs (118 articles) and the opportunity costs of industry sponsorship (72 articles). 221 articles reported on the impact of undertaking costly trials on translational research and health systems; of these, the most frequently reported consequences were to research integrity (52% of articles), research capacity (36% of articles) and running low-value trials (34% of articles). 254 articles provided recommendations to reduce trial costs; of these, the most frequently reported recommendations related to improvements in: operational efficiencies (33% of articles); patient accrual (24% of articles); funding for trials and transparency in trials reporting (18% of articles, each). CONCLUSION: Key findings from the review are: 1) delayed trial activation has costs to budgets and research; 2) poor accrual leads to low-value trials and wasted resources; 3) the pharmaceutical industry can be a pragmatic, if problematic, partner in clinical research; 4) organizational know-how and successful research collaboration are benefits of network/cooperative groups; and 5) there are spillover benefits of clinical trials to healthcare systems, including better health outcomes, enhanced research capacity, and drug cost avoidance. There is a need for more economic evaluations of the benefits of clinical research, such as health system use (or avoidance) and health outcomes in cities and health authorities with institutions that conduct clinical research, to demonstrate the affordability of clinical trials, despite their high cost.


Assuntos
Ensaios Clínicos como Assunto/economia , Pesquisa Biomédica/economia , Comportamento Cooperativo , Assistência à Saúde/economia , Indústria Farmacêutica/organização & administração , Humanos , Modelos Econômicos , Fatores de Tempo , Pesquisa Médica Translacional/economia
12.
J Spinal Cord Med ; 42(1): 102-122, 2019 01.
Artigo em Inglês | MEDLINE | ID: mdl-29485334

RESUMO

CONTEXT: Current treatment of spinal cord injury (SCI) focuses on cord stabilization to prevent further injury, rehabilitation, management of non-motor symptoms, and prevention of complications. Currently, no approved treatments are available, and limited treatment options exist for symptoms and complications associated with chronic SCI. This review describes the pharmacotherapy landscape in SCI from both commercial and research and development (R&D) standpoints through March 2015. METHODS: Information about specific compounds has been obtained through drug pipeline monographs in the Pharmaprojects® (Citeline, Inc., New York, New York, USA) drug database (current as of a search on May 30, 2014), websites of individual companies with compounds in development for SCI (current as of March 24, 2015), and a literature search of published R&D studies to validate the Pharmaprojects® source for selected compounds (current as of March 24, 2015). RESULTS: Types of studies conducted and outcomes measured in earlier phases of development are described for compounds in clinical development Currently four primary mechanisms are under investigation and may yield promising therapeutic targets: 1) neuronal regeneration; 2) neuroprotection (including anti-inflammation); 3) axonal reconnection; and 4) neuromodulation and signal enhancement. Many other compounds are no longer under investigation for SCI are mentioned; however, in most cases, the reason for terminating their development is not clear. CONCLUSION: There is urgent need to develop disease-modifying therapy for SCI, yet the commercial landscape remains small and highly fragmented with a paucity of novel late-stage compounds in R&D.


Assuntos
Desenvolvimento de Medicamentos/economia , Tratamento Farmacológico/economia , Traumatismos da Medula Espinal/tratamento farmacológico , Pesquisa Médica Translacional/economia , Desenvolvimento de Medicamentos/estatística & dados numéricos , Tratamento Farmacológico/estatística & dados numéricos , Humanos , Pesquisa Médica Translacional/estatística & dados numéricos
13.
Proc Natl Acad Sci U S A ; 115(50): 12608-12615, 2018 12 11.
Artigo em Inglês | MEDLINE | ID: mdl-30530666

RESUMO

Scientific prizes confer credibility to persons, ideas, and disciplines, provide financial incentives, and promote community-building celebrations. We examine the growth dynamics and interlocking relationships found in the worldwide scientific prize network. We focus on understanding how the knowledge linkages among prizes and scientists' propensities for prizewinning relate to knowledge pathways between disciplines and stratification within disciplines. Our data cover more than 3,000 different scientific prizes in diverse disciplines and the career histories of 10,455 prizewinners worldwide for over 100 years. We find several key links between prizes and scientific advances. First, despite an explosive proliferation of prizes over time and across the globe, prizes are more concentrated within a relatively small group of scientific elites, and ties among elites are highly clustered, suggesting that a relatively constrained number of ideas and scholars push the boundaries of science. For example, 64.1% of prizewinners have won two prizes and 13.7% have won five or more prizes. Second, certain prizes strongly interlock disciplines and subdisciplines, creating key pathways by which knowledge spreads and is recognized across science. Third, genealogical and coauthorship networks predict who wins multiple prizes, which helps to explain the interconnectedness among celebrated scientists and their pathbreaking ideas.


Assuntos
Distinções e Prêmios , Ciência , Interpretação Estatística de Dados , Humanos , Motivação , Prêmio Nobel , Ciência/economia , Ciência/tendências , Rede Social , Pesquisa Médica Translacional/economia , Pesquisa Médica Translacional/tendências
14.
Public Health Res Pract ; 28(3)2018 Sep 27.
Artigo em Inglês | MEDLINE | ID: mdl-30406260

RESUMO

BACKGROUND: Bridging the 'gap' between research evidence and the complexities of policy and practice is central to health improvement. The Translational Research Grants Scheme (TRGS) in New South Wales (NSW), Australia, is a funding scheme aimed at reducing the time between research generation and translation to policy and practice. The TRGS is also an important part of NSW Health's efforts to harness and strengthen research capacity to improve health service delivery. METHODS: A document review and interviews (n = 12) with key stakeholders were undertaken following the first round of TRGS funding in November 2016. The communications from continuing quality improvement processes over the three funding rounds have provided further insight. RESULTS AND DISCUSSION: A total of 53 projects have been funded under the scheme, with recipients across many NSW Health organisations. NSW Health has committed more than $24 million to date. Round one of the TRGS was received well by the policy makers, Local Health Districts and research stakeholders interviewed. Of particular note were: the requirement for Chief Executives to demonstrate strong support for the implementation of findings; requirements to partner with state-wide policy leads and clinical networks; and capacity-building outcomes of the scheme. The ongoing quality improvement processes indicate that the program continues to be well received, with improvements to partnership arrangements, and an acknowledgement of the challenge that arises because the scheme, by nature of its capacity-building aim, attracts proposals from a range of research experience. LESSONS LEARNT: The TRGS is filling an important gap in the research funding landscape in NSW and is well regarded by stakeholders. To ensure that the TRGS is achieving its intended aims, an evaluation of the impact of the scheme will take place during 2018-19.


Assuntos
Pesquisa sobre Serviços de Saúde/economia , Apoio à Pesquisa como Assunto , Pesquisa Médica Translacional/economia , Fortalecimento Institucional , Programas Governamentais , Humanos , Entrevistas como Assunto , New South Wales , Melhoria de Qualidade
15.
Public Health Res Pract ; 28(3)2018 Sep 27.
Artigo em Inglês | MEDLINE | ID: mdl-30406264

RESUMO

OBJECTIVES: The Prevention Research Support Program (PRSP) is a New South Wales (NSW) Ministry of Health funding scheme. The scheme aims to build capability, and strengthen prevention and early intervention research that is important to the NSW public health system (NSW Health) and that leads to improved health and reduced health inequities for the people of NSW. This paper describes how PRSP funding has supported recipients to produce high-quality, policy-relevant research, and increase the impact of research on policy and practice. Type of program: The PRSP is a competitive funding program that supports NSW research organisations that conduct prevention and early intervention research that aligns with NSW Health priorities. The objectives of the PRSP are to: increase high-quality and internationally recognised prevention research in NSW; support the generation of research evidence that addresses NSW Health prevention priorities, including cross-government priorities; encourage the adoption of research evidence in relevant policies, programs and services in NSW; and build the prevention research capability of NSW Health staff and the NSW Health system. METHODS: Funding recipients provide information about their research, translation and capability building achievements in their funding applications and submit annual progress reports. Data from these sources were aggregated to illustrate trends in indicators of research excellence over time. Prior to the most recent call for applications, the program was reviewed. The review included consultations with funding recipients, policy and practice partners, and key funding stakeholders. Stakeholders' perceptions of the benefits and challenges associated with the PRSP were drawn from the consultation data. RESULTS: PRSP funding recipients demonstrate considerable increases over time on several indicators of research excellence, including peer-reviewed journal publications, grant income, and research students supervised. Recipients use a range of strategies to ensure dialogue with health system partners, and report research impacts at the local, state, national and international levels. PRSP funding also supports the development of research capability. LESSONS LEARNT: The PRSP is a unique scheme that is highly valued by both funding recipients and health system stakeholders. The continuity of funding provided under the scheme enables recipients to adopt a strategic approach to their research and develop innovative strategies to support its conduct and use.


Assuntos
Fortalecimento Institucional , Pesquisa sobre Serviços de Saúde/economia , Inovação Organizacional , Prática de Saúde Pública/economia , Apoio à Pesquisa como Assunto , Pesquisa Médica Translacional/economia , Programas Governamentais , Política de Saúde , Prioridades em Saúde , Humanos , New South Wales , Desenvolvimento de Programas , Avaliação de Programas e Projetos de Saúde
16.
Lancet Oncol ; 19(10): e521-e533, 2018 10.
Artigo em Inglês | MEDLINE | ID: mdl-30303126

RESUMO

The 2013 Breast Cancer Campaign gap analysis established breast cancer research priorities without a specific focus on surgical research or the role of surgeons on breast cancer research. This Review aims to identify opportunities and priorities for research in breast surgery to complement the 2013 gap analysis. To identify these goals, research-active breast surgeons met and identified areas for breast surgery research that mapped to the patient pathway. Areas included diagnosis, neoadjuvant treatment, surgery, adjuvant therapy, and attention to special groups (eg, those receiving risk-reducing surgery). Section leads were identified based on research interests, with invited input from experts in specific areas, supported by consultation with members of the Association of Breast Surgery and Independent Cancer Patients' Voice groups. The document was iteratively modified until participants were satisfied that key priorities for surgical research were clear. Key research gaps included issues surrounding overdiagnosis and treatment; optimising treatment options and their selection for neoadjuvant therapies and subsequent surgery; reducing rates of re-operations for breast-conserving surgery; generating evidence for clinical effectiveness and cost-effectiveness of breast reconstruction, and mechanisms for assessing novel interventions; establishing optimal axillary management, especially post-neoadjuvant treatment; and defining and standardising indications for risk-reducing surgery. We propose strategies for resolving these knowledge gaps. Surgeons are ideally placed for a central role in breast cancer research and should foster a culture of engagement and participation in research to benefit patients and health-care systems. Development of infrastructure and surgical research capacity, together with appropriate allocation of research funding, is needed to successfully address the key clinical and translational research gaps that are highlighted in this Review within the next two decades.


Assuntos
Neoplasias da Mama/cirurgia , Mastectomia/tendências , Oncologia/tendências , Pesquisa/tendências , Pesquisa Médica Translacional/tendências , Neoplasias da Mama/economia , Neoplasias da Mama/mortalidade , Neoplasias da Mama/patologia , Difusão de Inovações , Feminino , Previsões , Humanos , Mastectomia/efeitos adversos , Mastectomia/economia , Mastectomia/mortalidade , Oncologia/economia , Terapia Neoadjuvante/tendências , Metástase Neoplásica , Papel do Médico , Pesquisa/economia , Apoio à Pesquisa como Assunto/tendências , Cirurgiões/tendências , Pesquisa Médica Translacional/economia , Resultado do Tratamento
20.
BMJ Evid Based Med ; 23(4): 131-136, 2018 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-29941656

RESUMO

In order to ensure the effective transfer of research knowledge to those who can effect positive changes in practice, models of knowledge transfer and exchange (KTE) are required. Limited evidence exists as to how palliative care researchers use existing models to support their practice and to what extent they are perceived as effective. We set out to identify factors that influence KTE planning and implementation through semistructured interviews with experienced palliative care researchers in Ireland. Issues around KTE were drawn out through thematic analysis. Nine interviews were held with investigators on eight research projects. Ten themes were identified and categorised as either barriers or facilitators to KTE. Perceived barriers included inadequate time and funding, limited institutional capacity, competing priorities, weak communication channels and negative perceptions of palliative care. Perceived facilitators included dedicated time and resources, aligned priorities, strong professional networks, multipronged approach and KTE experience. In order to improve the quality, acceptability and reach of palliative research, it is vital that researchers improve their understanding of KTE within the context of palliative care, moving beyond academic dissemination to achieve research-informed practice by overcoming barriers to KTE through facilitated action. This study provides an overview of factors that influence KTE planning and implementation among palliative care researchers.


Assuntos
Pesquisa sobre Serviços de Saúde , Cuidados Paliativos , Pesquisa Médica Translacional , Prioridades em Saúde , Pesquisa sobre Serviços de Saúde/economia , Humanos , Comunicação Interdisciplinar , Percepção , Apoio à Pesquisa como Assunto , Participação dos Interessados , Pesquisa Médica Translacional/economia
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