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1.
Gac. méd. Méx ; 155(3): 319-321, may.-jun. 2019.
Article in English, Spanish | LILACS | ID: biblio-1286508

ABSTRACT

Resumen La investigación clínica es la herramienta de mayor importancia para la identificación de estrategias diagnósticas y terapéuticas que deriven en mayor eficacia y seguridad. A pesar de su trascendencia, la implementación exitosa de la investigación clínica presenta numerosas dificultades; entre las más relevantes se encuentra la poca disponibilidad de recursos para realizar ensayos clínicos independientes. Por lo general, la industria farmacéutica absorbe los costos asociados con la mayoría de los ensayos clínicos, sin embargo, esto puede generar una disociación entre los temas de interés y las prioridades en salud, al existir interés económico como principal motivación de estos protocolos. Además del papel relevante de la industria farmacéutica, es importante que las instancias gubernamentales favorezcan las condiciones, tanto económicas como regulatorias, para la implementación de investigación clínica independiente, que aborde temas de interés médico y terapéutico, aunque no genere beneficios económicos empresariales.


Abstract Clinical research is the most important tool for the identification of diagnostic and therapeutic strategies that derive in higher efficacy and safety. Despite its significance, successful implementation of clinical research faces numerous difficulties, with one the most relevant being limited availability of resources for the performance of independent clinical trials. Generally, the pharmaceutical industry absorbs the costs associated with most clinical trials; however, this can generate dissociation between subjects of interest and health priorities when economic interest is the main driver of these protocols. In addition to the relevant role played by the pharmaceutical industry, it is important that government agencies favor adequate conditions, both in economic and regulatory aspects, for the implementation of independent clinical research that addresses subjects of medical and therapeutic interest, even if it does not generate corporate economic benefits.


Subject(s)
Humans , Clinical Trials as Topic/organization & administration , Biomedical Research/organization & administration , Drug Industry/organization & administration , Financial Support , Clinical Trials as Topic/economics , Biomedical Research/economics , Drug Industry/economics
5.
Indian J Med Ethics ; 2013 Apr-Jun ; 10 (2): 76-79
Article in English | IMSEAR | ID: sea-153604

ABSTRACT

In 2005, the government amended Schedule Y of the Drugs and Cosmetics Act, 1940, and Rules, 1945, to liberalise the conduct of global drug trials in India. Proponents of this policy had asserted that we needed less, and not more, regulation, in order to expand the business of drug trials. Many from the medical profession, the bioethics community and civil society groups have been critical of this policy.


Subject(s)
Civil Rights/legislation & jurisprudence , Clinical Trials as Topic/adverse effects , Clinical Trials as Topic/economics , Clinical Trials as Topic/legislation & jurisprudence , Compensation and Redress/legislation & jurisprudence , Drug-Related Side Effects and Adverse Reactions/economics , Homicide/economics , Homicide/legislation & jurisprudence , Human Experimentation/legislation & jurisprudence , Humans , India , Research Subjects/legislation & jurisprudence , Wounds and Injuries/economics
6.
Indian J Med Ethics ; 2013 Jan-Mar ; 10 (1): 63-64
Article in English | IMSEAR | ID: sea-153557

ABSTRACT

The world of clinical trials is ethically fragile. Huge amounts of money are at stake and a handful of people are privy to a lot of confidential information about the trials. This imbalance in money and knowledge sometimes results in an unholynexus. Known as insider trading, progress reports of a trial are sometimes passed on to investors so that they can augment or deplete their share in the investment before the trial results are officially made public. The person(s) passing on the information would also have vested interests in the profits. This unmitigatedly unethical practice is explored by the book, using the genre of a murder thriller.


Subject(s)
Book Reviews as Topic , Clinical Trials as Topic/economics , Clinical Trials as Topic/methods
9.
Rio de Janeiro; s.n; 2010. 37 p. ilus, tab.
Thesis in Portuguese | LILACS | ID: lil-601247

ABSTRACT

O estudo teve como objetivo avaliar a razão de custo-efetividade, sob a perspectiva do Sistema Único de Saúde - SUS, do tratamento da anemia de pacientes em Terapia Renal Substitutiva. Duas alternativas foram comparadas: um novo medicamento recentemente registrado no Brasil, o Ativador Contínuo de Receptor de Eritropoetina (Continuous Erythropoitin Receptor Activador), CERA, e outro, atualmente disponível no sistema de saúde brasileiro, a Eritropoetina Recombinante Humana - EPO-rHu. Métodos: Um modelo de Markov simulou o curso de uma coorte de pacientes em Terapia Renal Substitutiva tratados com CERA e Epo-Hu por quatro anos. A qualidade de vida associada ao uso dos medicamentos foi estimada de forma indireta, por meio de entrevista qualificada com os profissionais cuidadores, previamente submetida e aprovada pelo Comitê de Ética em Pesquisa local. Foi realizada análise de sensibilidade no modelo proposto através da variação dos parâmetros: doses dos medicamentos, custo das estratégias, taxas de desconto e efetividade utilizados para sua construção. Resultados: A média da qualidade de vida atribuída aos pacientes tratados foi 6,3 para Epo-rHu, 7,8 para o CERA e 9,3 para os pacientes transplantados. O modelo demonstrou que a estratégia mais custo-efetiva é a terapêutica com a Epo-rHu, com um custo por QALY de R$21.052,00. O custo incremental por QALY ganho associado ao CERA foi de 72.974,00. Conclusão: A utilização mensal do medicamento CERA está associada à maior qualidade de vida quando comparada a EPO-rHu. No entanto, a terapia com o novo medicamento não se mostrou mais custo-efetiva frente ao tratamento com EPO-rHu.


Subject(s)
Humans , Male , Female , Cost-Benefit Analysis/economics , Cost-Benefit Analysis/statistics & numerical data , Cost-Benefit Analysis/trends , Cost-Benefit Analysis , Anemia/economics , Renal Replacement Therapy , Unified Health System , Drug Evaluation/economics , Erythropoietin , Clinical Trials as Topic/economics , Erythropoietin/therapeutic use , Receptors, Erythropoietin
10.
Rev. Assoc. Med. Bras. (1992) ; 56(4): 428-433, 2010. graf, tab
Article in English | LILACS | ID: lil-557322

ABSTRACT

OBJECTIVE: To evaluate biopharmaceutical industry-sponsored clinical trials placed in countries previously described as emerging regions for clinical research, and potential differences for those placed in Brazil. METHODS: Data regarding recruitment of subjects for clinical trials were retrieved from www.clinicaltrials.gov on February 2nd 2009. Proportions of sites in each country were compared among emerging countries. Multiple logistic regressions were performed to evaluate whether trial placement in Brazil could be predicted by trial location in other countries and/or by trial features. RESULTS: A total of 8,501 trials were then active and 1,170 (13.8 percent) included sites in emerging countries (i.e., Argentina, Brazil, China, Czech Republic, Hungary, India, Mexico, Poland, Russia, South Korea, and South Africa). South Korea and China presented a significantly higher proportion of sites when compared to other countries (p<0.05). Multiple logistic regressions detected no negative correlation between placement in other countries when compared to Brazil. Trials involving subjects with less than 15 years of age, those with targeted recruitment of at least 1,000 subjects, and seven sponsors were identified as significant predictors of trial placement in Brazil. CONCLUSION: No clear direct competition between Brazil and other emerging countries was detected. South Korea showed the higher proportion of sites and ranked third in total number of trials, appearing as a major player in attractiveness for biopharmaceutical industry-sponsored clinical trials.


OBJETIVO: Avaliar ensaios clínicos patrocinados pela indústria biofarmacêutica alocados em países previamente definidos como emergentes em pesquisa clínica e possíveis diferenças naqueles alocados no Brasil. MÉTODOS: Dados de ensaios clínicos recrutando pacientes foram obtidos (www.clinicaltrials.gov) em 2 de fevereiro de 2009. As proporções de centros em cada país foram comparadas entre os países emergentes. Regressões logísticas múltiplas foram realizadas para avaliar a alocação do ensaio em outros países emergentes e as características do ensaio como preditores da presença de algum centro no Brasil RESULTADOS: No total, 8.501 ensaios clínicos estavam ativos à época, e 13,8 por cento destes (N=1.170) incluíam centros em países emergentes (i.e., Argentina, Brasil, China, República Tcheca, Hungria, Índia, México, Polônia, Rússia, Coreia do Sul, e África do Sul). Coreia do Sul e China apresentaram uma proporção de centros significativamente superior aos outros países (p<0,05). Não se detectou correlação negativa na alocação de ensaios no Brasil quando comparada com outros países. Ensaios envolvendo sujeitos com idade menor que 15 anos, com o recrutamento planejado de pelo menos 1.000 sujeitos e sete patrocinadores, foram identificados como preditores significativos da alocação de centros no Brasil. CONCLUSÃO: Não se detectou competição direta entre o Brasil e outro país emergente. A Coreia do Sul apresentou a maior proporção de centros e foi o terceiro país em número total de ensaios, demonstrando ser um importante país em termos de atratividade para ensaios clínicos patrocinados pela indústria biofarmacêutica.


Subject(s)
Female , Humans , Clinical Trials as Topic/statistics & numerical data , Developing Countries/statistics & numerical data , Drug Industry/statistics & numerical data , Financial Support , Clinical Trials as Topic/economics , Drug Industry/economics , Multivariate Analysis
12.
ACIMED ; 19(5)mayo 2009.
Article in Spanish | LILACS | ID: lil-531486

ABSTRACT

La producción científica relacionada con los ensayos clínicos en el territorio de Villa Clara creció considerablemente durante los años 2007-2008, un período en el que se publicó un total de 25 artículos científicos en revistas nacionales acreditadas por el Ministerio de Ciencia, Tecnología y Medio Ambiente (CITMA) y extranjeras, procesadas por bases de datos de reconocido prestigio...


Subject(s)
Clinical Trials as Topic/economics , Publication Bias , Scientific Publication Indicators
16.
Article in English | IMSEAR | ID: sea-119233

ABSTRACT

Pharmacoeconomics focuses on the costs and benefits of drug therapy and pharmacoeconomic evaluations provide a basis for resource allocation and utilization. It is increasingly becoming important for health policy decision-making. A pharmacoeconomic evaluation may be conducted as an economic assessment incorporated into clinical trials. Such trials should compare the new drug/procedure with an older drug or existing intervention. Four techniques are used for economic evaluation, namely, cost-minimization analysis, cost-effectiveness analysis, cost-utility analysis and cost-benefit analysis. The choice of the evaluation method depends on the nature of outcomes and the context in which the choices need to be made. Pharmacoeconomics is a young science that will improve with application. Its need is undeniable, especially in developing countries.


Subject(s)
Clinical Trials as Topic/economics , Cost-Benefit Analysis/methods , Decision Making , Drug Costs , Economics, Pharmaceutical , Health Policy/economics , Health Services Research , Humans , Resource Allocation
17.
Article in English | IMSEAR | ID: sea-95564

ABSTRACT

BACKGROUND: Malaria is a major public health problem representing 2.3% of the overall global disease burden. The cost of treatment of malaria continues to rise as older drugs and insecticides become less effective and are replaced by more effective, but also more expensive products. METHODS: A post-hoc pharmacoeconomic analysis (direct and indirect costs only) of three antimalarials, chloroquine, mefloquine and co-artemether, was carried out to address the problem of switch to a more expensive first-line antimalarial in the face of growing chloroquine resistance. RESULTS: From the perspective of a large public hospital, it was seen that in an area of high grade chloroquine resistance, the total expenditure on patients who fail chloroquine would exceed the excess expenditure on mefloquine when the RII + RIII resistance exceeded 9%. CONCLUSIONS: Switch to a more expensive drug like mefloquine as a first-line option would be cost-effective when the moderate-severe chloroquine resistance exceeded 9%.


Subject(s)
Antimalarials/economics , Artemisinins/economics , Chloroquine/economics , Clinical Trials as Topic/economics , Cost-Benefit Analysis , Drug Combinations , Economics, Pharmaceutical , Female , Fluorenes/economics , Hospitalization/economics , Humans , India , Malaria, Falciparum/drug therapy , Male , Mefloquine/economics , Sesquiterpenes/economics
19.
Article in English | IMSEAR | ID: sea-44479

ABSTRACT

BACKGROUND: Thailand started the anti-retroviral supply program in 1992 primarily for low income groups. The budget has increased but coverage has decreased due to the large number of cases requesting supply. Rapid advancement of HIV therapy has resulted in higher drug cost which is not affordable to people in developing countries. The cost effectiveness review in 1995, conducted by staff of the World Bank, World Health Organization, and Ministry of Public Health (MOPH), demonstrated high cost with limited benefit. It encouraged program evolution, from "supply for services" to "supply for research". Faced with an expanding AIDS epidemic and economic set back, Thailand has to adapt its program to fit scientific, ethic, and economic situations. ACTIVITIES: The program now extends to (a) adapting current therapeutic regimens, (b) developing new treatment and (c) natural history study of people with HIV/AIDS who receive anti-retrovirals (ARV), anti-opportunistic infections (anti OIs), or alternative care. Laboratory issues, and prevention activities are also included. To allocate an approximately 300 million baht budget each year, participating hospitals were invited to submit proposals for consideration. Proposals were ranked and supported according to scores and research priority. A clinical research network was set up in 1996 and supply was shipped out in 1997 on double combination for 1,200 cases, with triple combination for 40 cases, all in 58 sites. Investigators were trained for Good Clinical Practices (GCP) to reassure data handling quality. Psychological and social support were encouraged through the health system research network. Until 15 Jan 98, 49 proposals were submitted (42 ARV, 1 herbal medicine, 6 pediatrics/perinatals). A working group consisting of local experts from medical schools, and the MOPH together ranked these proposals. Those with high scores received medical supplies while the low scores received technological advice in order to increase their capability to participate in research in the near future. CONCLUSIONS: Central supply encouraged physicians to treat more cases but discouraged their hospitals to set up their own budget. The clinical research network allowed team and infrastructure building up which can be adapted for drug, vaccine trials and observational databases. More training is needed. For other developing countries, Thailand's experiences should be perceived as an example not a model.


Subject(s)
Anti-HIV Agents/economics , Clinical Trials as Topic/economics , Delivery of Health Care/trends , Developing Countries , HIV Infections/economics , Humans , Thailand
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