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Health Res Policy Syst ; 19(1): 54, 2021 Apr 01.
Artículo en Inglés | MEDLINE | ID: mdl-33794906


The COVID-19 pandemic has shed a spotlight on the resilience of healthcare systems, and their ability to cope efficiently and effectively with unexpected crises. If we are to learn one economic lesson from the pandemic, arguably it is the perils of an overfocus on short-term allocative efficiency at the price of lack of capacity to deal with uncertain future challenges. In normal times, building spare capacity with 'option value' into health systems may seem inefficient, the costs potentially exceeding the benefits. Yet the fatal weakness of not doing so is that this can leave health systems highly constrained when dealing with unexpected, but ultimately inevitable, shocks-such as the COVID-19 pandemic. In this article, we argue that the pandemic has highlighted the potentially enormous option value of biomedical research infrastructure. We illustrate this with reference to COVID-19 response work supported by the United Kingdom National Institute for Health Research Oxford Biomedical Research Centre. As the world deals with the fallout from the most serious economic crisis since the Great Depression, pressure will soon come to review government expenditure, including research funding. Developing a framework to fully account for option value, and understanding the public appetite to pay for it, should allow us to be better prepared for the next emerging problem.

Investigación Biomédica/economía , /prevención & control , Apoyo a la Investigación como Asunto , Humanos , Medicina Estatal/economía , Reino Unido/epidemiología
Sci Transl Med ; 13(584)2021 03 10.
Artículo en Inglés | MEDLINE | ID: mdl-33692133


The COVID-19 pandemic halted research operations at academic medical centers. This shutdown has adversely affected research infrastructure, the current research workforce, and the research pipeline. We discuss the impact of the pandemic on overall research operations, examine its disproportionate effect on underrepresented minority researchers, and provide concrete strategies to reverse these losses.

Centros Médicos Académicos , Selección de Profesión , Pandemias , /fisiología , Investigación Biomédica/economía , Humanos , Grupos Minoritarios , Apoyo a la Investigación como Asunto/economía
Proc Natl Acad Sci U S A ; 118(6)2021 02 09.
Artículo en Inglés | MEDLINE | ID: mdl-33531366


With more time being spent on caregiving responsibilities during the COVID-19 pandemic, female scientists' productivity dropped. When female scientists conduct research, identity factors are better incorporated in research content. In order to mitigate damage to the research enterprise, funding agencies can play a role by putting in place gender equity policies that support all applicants and ensure research quality. A national health research funder implemented gender policy changes that included extending deadlines and factoring sex and gender into COVID-19 grant requirements. Following these changes, the funder received more applications from female scientists, awarded a greater proportion of grants to female compared to male scientists, and received and funded more grant applications that considered sex and gender in the content of COVID-19 research. Further work is urgently required to address inequities associated with identity characteristics beyond gender.

/epidemiología , Equidad de Género , Políticas , Investigadores/estadística & datos numéricos , Distinciones y Premios , Investigación Biomédica/economía , Investigación Biomédica/organización & administración , Eficiencia , Femenino , Organización de la Financiación/estadística & datos numéricos , Humanos , Masculino , Pandemias , Investigadores/economía , Factores Sexuales
Health Aff (Millwood) ; 40(3): 400-409, 2021 03.
Artículo en Inglés | MEDLINE | ID: mdl-33539184


The coronavirus disease 2019 (COVID-19) pandemic response brought forth major changes in innovation policy. This article takes stock of the key features of the COVID-19 innovation system-the network of public and private actors influencing the development and diffusion of technologies to combat the pandemic. Before the pandemic, biomedical research and development policy consisted largely of "push" funding from the public sector in support of basic research and "pull" incentives from patents to motivate private companies to invest in clinical trials and develop drugs and vaccines. In contrast, during the pandemic, public funding shifted its focus to late-stage product development and manufacturing. Procurement agreements with governments replaced traditional pull incentives from patents for the major private companies. Nonpatent barriers to competition may also have incentivized innovation. The challenges to ensuring diffusion have gained in prominence during the pandemic, though it is unclear what role patents will play in pricing and access. Some aspects of this approach to biomedical innovation may be unique to crises, but others could provide lessons for policy beyond the pandemic.

Investigación Biomédica/economía , Difusión de Innovaciones , Desarrollo de Medicamentos/economía , Asociación entre el Sector Público-Privado , Humanos
Health Aff (Millwood) ; 40(3): 410-418, 2021 03.
Artículo en Inglés | MEDLINE | ID: mdl-33539191


Coronavirus disease 2019 (COVID-19) vaccine development and manufacturing have proceeded at a historically unprecedented pace. This speed may be accounted for by the unprecedented scale of resources being devoted to addressing COVID-19; an unusual intensity of cooperation, encompassing the public and private sectors and occurring both within and across national borders; and innovation with respect to both technologies (for example, new vaccine platforms) and processes (for example, vaccine clinical trials). In this article we describe and analyze how resources, cooperation, and innovation have contributed to the accelerated development of COVID-19 vaccines. Similar levels and types of public investment, models of cooperation, and harnessing of innovative processes and technologies could be applied to future epidemics and other global health challenges.

Investigación Biomédica/economía , Desarrollo de Medicamentos/economía , Salud Pública , Asociación entre el Sector Público-Privado , Humanos
Cancer Immunol Res ; 9(3): 261-264, 2021 03.
Artículo en Inglés | MEDLINE | ID: mdl-33452008


The immunomodulatory effects of immune-checkpoint blockade (ICB) therapy for cancer may act at the crossroads between the need to increase antiviral immune responses to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and to decrease the inflammatory responses in severe cases of coronavirus disease 2019 (COVID-19). There is evidence from preclinical models that blocking programmed death receptor 1 (PD1) protects against RNA virus infections, which suggests that patients with cancer receiving ICB may have lower rates of viral infection. However, given the heterogeneity of patient characteristics, this would be difficult to demonstrate using population-based registries or in clinical trials. Most studies of the impact of ICB therapy on the course of COVID-19 have centered on studying its potential detrimental impact on the course of the COVID-19 infection, in particular on the development of the most severe inflammatory complications. This is a logical concern as it is becoming clear that complications of COVID-19 such as severe respiratory distress syndrome are related to interferon signaling, which is the pathway that leads to expression of the PD1 ligand PD-L1. Therefore, PD1/PD-L1 ICB could potentially increase inflammatory processes, worsening the disease course for patients. However, review of the current evidence does not support the notion that ICB therapy worsens complications from COVID-19, and we conclude that it supports the continued use of ICB therapy during the COVID-19 pandemic provided that we now collect data on the effects of such therapy on COVID-19 vaccination.

/complicaciones , /uso terapéutico , Neoplasias/terapia , Antígeno B7-H1/metabolismo , Investigación Biomédica/economía , Investigación Biomédica/legislación & jurisprudencia , Humanos , Inflamación , Neoplasias/complicaciones , Neoplasias/inmunología , Pandemias , Pronóstico , Receptor de Muerte Celular Programada 1/metabolismo , Transducción de Señal
Health Res Policy Syst ; 19(1): 10, 2021 Jan 21.
Artículo en Inglés | MEDLINE | ID: mdl-33478499


BACKGROUND: The coronavirus disease 2019 (COVID-19) pandemic has spread throughout more than 160 countries, infecting millions of people worldwide. To address this health emergency, countries have organized the flow of production and innovation to reduce the impact on health. This article shows the response of the Brazilian scientific community to meet the urgent needs of the public unified health system [SUS], aiming to guarantee universal access to an estimated population of 211 million. By December 2020, Brazil had recorded more than six million cases and approximately 175,000 deaths. METHODS: We collected data on research, development and innovation projects carried out by 114 public universities (plus Oswaldo Cruz Foundation [Fiocruz] and Butantan Institute), as reported on their websites. Additionally, we examined the studies on COVID-19 approved by the National Comission for Research Ethics, as well as those reported on the Ministry of Education website as of May 15, 2020. RESULTS: The 789 identified projects were classified according to research categories as follows: development and innovation (n = 280), other types of projects (n = 226), epidemiologic research (n = 211), and basic research on disease mechanisms (n = 72). Most proposals focused on the development and innovation of personal protective equipment, medical devices, diagnostic tests, medicines and vaccines, which were rapidly identified as research priorities by the scientific community. Some promising results have been observed from phase III vaccine trials, one of which is conducted in partnership with Oxford University and another of which is performed with Sinovac Biotech. Both trials involve thousands of volunteers in their Brazilian arms and include technology transfer agreements with Fiocruz and the Butantan Institute, respectively. These vaccines proved to be safe and effective and were immediately licensed for emergency use. The provision of doses for the public health system, and vaccination, started on January 17, 2021. CONCLUSIONS: The mobilized Brazilian scientific community has generated comprehensive research, development and innovation proposals to meet the most urgent needs. It is important to emphasize that this response was only possible due to decades of investment in research, development and innovation in Brazil. We need to reinforce and protect the Brazilian science, technology and innovation system from austerity policies that disregard health and knowledge as crucial investments for Brazilian society, in line with the constitutional right of universal health access and universal health coverage.

Investigación Biomédica , Prestación de Atención de Salud , Pandemias , Salud Pública , Investigación Biomédica/economía , Brasil/epidemiología , Economía , Urgencias Médicas , Humanos , Industrias , Apoyo a la Investigación como Asunto , Investigación en Medicina Traslacional , Universidades , Vacunación , Vacunas
JAMA Netw Open ; 4(1): e2034890, 2021 01 04.
Artículo en Inglés | MEDLINE | ID: mdl-33502486


Importance: Prior research suggests an association between burden of disease and National Institutes of Health (NIH) funding. The allocation of NIH funding should reflect, to some extent, the health needs of the population, along with other factors. Objective: To examine the factors associated with NIH funding in 2019 for 46 diseases. Design, Setting, and Participants: This cohort study used disability-adjusted life-years to measure the 2008 and 2019 US burden of disease and compared them with NIH categoric funding for 46 diseases. Exposures: Disability-adjusted life-years to measure the 2008 and 2019 US burden of disease, 2016 health spending, and 2008 NIH funding levels for 46 diseases. Main Outcomes and Measures: 2019 NIH funding levels for 46 diseases. Results: The 46 diseases accounted for 62 392 713 of 94 399 784 disability-adjusted life-years (66.1%) in 2008 and 75 706 718 of 111 074 472 disability-adjusted life-years (68.2%) in 2019, representing more than 66% of all disability-adjusted life-years in both years. By dollar volume, Alzheimer and dementia increased the most, with approximately $1.8 billion more funding in 2019 than 2008 (from $530 million in 2008 to $2398 million in 2019, a 352% increase), whereas interpersonal violence had the greatest decrease, $95 million, in 2019 NIH funding (from $236 million in 2008 to $141 million in 2019, a 40% decrease). For the 46 diseases in this study, the variable with the greatest association with NIH funding in 2019 was the level of NIH funding in 2008, with a simple correlation of 0.88. Burden of disease and changes in burden of disease were not statistically significantly associated with NIH funding levels once the prior level of funding was included in the model. The models suggested that a 1% higher level of NIH funding in 2008 was associated with a 0.91% higher level of NIH funding in 2019. Conclusions and Relevance: In this study, NIH spending for most diseases seemed to be based primarily on the level of NIH spending more than 10 years earlier, despite changes in burden of disease. Congress and the NIH should examine the allocation process to ensure NIH investments are responsive to changes in the health of the population.

Investigación Biomédica/economía , National Institutes of Health (U.S.) , Apoyo a la Investigación como Asunto/economía , Humanos , Asignación de Recursos , Estados Unidos
Cancer Discov ; 11(3): 527-528, 2021 03.
Artículo en Inglés | MEDLINE | ID: mdl-33472835


As vice president, Joe Biden was the cancer advocate-in-chief. As president, he has a different public health crisis to deal with-COVID-19-but given Biden's passion for cancer research, many expect he will build on the previous Moonshot initiative with another push to accelerate the pace of progress in cancer control.

Investigación Biomédica/economía , Investigación Biomédica/legislación & jurisprudencia , Política de Salud , Neoplasias/epidemiología , Neoplasias/terapia , Política , /economía , Financiación Gubernamental , Programas de Gobierno/organización & administración , Humanos , Objetivos Organizacionales , Pandemias , Apoyo a la Investigación como Asunto , Estados Unidos
Cancer Discov ; 11(3): 524, 2021 03.
Artículo en Inglés | MEDLINE | ID: mdl-33483379


The federal spending bill enacted by the U.S. Congress in December for fiscal year 2021 totals $1.4 trillion, plus another $900 billion in emergency COVID-19 relief funding. The $1.4 trillion includes budget increases for the NIH, NCI, and FDA that help the agencies keep pace with inflation. Research advocates say more than $10 billion in emergency supplemental funds for the NIH is urgently needed to support medical research affected by the COVID-19 pandemic.

Investigación Biomédica/legislación & jurisprudencia , Gobierno Federal , Política de Salud , Neoplasias/terapia , Apoyo a la Investigación como Asunto , Investigación Biomédica/economía , /economía , Humanos , Oncología Médica/organización & administración , National Cancer Institute (U.S.)/economía , National Institutes of Health (U.S.)/economía , Neoplasias/economía , Sociedades Médicas , Estados Unidos , United States Food and Drug Administration/economía
Rev. bioét. derecho ; (50): 407-423, nov. 2020. tab, graf
Artículo en Portugués | IBECS | ID: ibc-191365


O processo de consentimento informado para participação de pesquisa com seres humanos visa fornecer as informações adequadas ao indivíduo possibilitando que este tome a decisão de participar de maneira voluntária, livre de pressões externas. A possibilidade de remuneração poderia interferir na voluntariedade deste processo de consentir. O presente estudo objetivou avaliar percepção de influência da remuneração monetária por meio de simulações de pesquisa que variam em nível de risco (Bioequivalência e de Fase I) e tipo de remuneração monetária (com e sem). Participaram do estudo 80 voluntários. Os resultados sugerem que a remuneração não constituiu uma interferência na voluntariedade do processo de consentimento, visto que participantes aceitaram convite para participar da primeira pesquisa para a qual foram convidados e não se sentiram influenciados indebidamente

El proceso de consentimiento informado para la participación de sujetos humanos en investigación tiene por objeto dar la información adecuada al individuo, permitiendo que tome la decisión de participar de manera voluntaria y libre de presiones externas. La posibilidad de remuneración podría interferir en la voluntariedad de este proceso de consentir. El presente estudio evalúa la percepción de la influencia de la remuneración monetaria a través de simulaciones de investigación que varían en nivel de riesgo (Bioequivalencia y de Fase I) y tipo de remuneración monetaria (con y sin). Participaron del estudio 80 voluntarios. Los resultados sugieren que la remuneración no constituyó una interferencia en la voluntariedad del proceso de consentimiento, ya que los participantes aceptaron una invitación para participar en la primera encuesta a la que fueron invitados y no se sintieron influenciados incorrectamente

The process of informed consent for research participation with human beings aims to provide appropriate information to individuals enabling him or her to make the decision to participate voluntarily, free of external pressures. The possibility of remuneration could interfere in the willingness to consent. The present study aims to evaluate the perception of influence of the monetary payment through research simulations that vary in the level of risk (Bioequivalence and Phase I) and type of monetary payment (with and without). Eighty volunteers participated in the study. The results suggest that remuneration did not interfere with the willingness of the consent process, as participants accepted an invitation to participate in the first research option to which they were invited to and did not feel undue influence

El procés de consentiment informat per a la participació de subjectes humans en recerca té per objecte donar la informació adequada a l'individu, permetent que prengui la decisió de participar de manera voluntària I lliure de pressions externes. La possibilitat de remuneració podria interferir en la voluntarietat d'aquest procés de consentir. El present estudi avalua la percepció de la influència de la remuneració monetària a través de simulacions de recerca que varien en nivell de risc (Bioequivalencia I de Fase I) I tipus de remuneració monetària (amb I sense). Van participar de l'estudi 80 voluntaris. Els resultats suggereixen que la remuneració no va constituir una interferència en la voluntarietat del procés de consentiment, ja que els participants van acceptar una invitació per a participar en la primera enquesta a la qual van ser convidats I no es van sentir influenciats incorrectament

Humanos , Masculino , Femenino , Adolescente , Adulto Joven , Adulto , Persona de Mediana Edad , Anciano , Investigación Biomédica/economía , Remuneración , Decisiones , Consentimiento Informado , Ética en Investigación , Factores Socioeconómicos