Reflections on FDA and WHO recommendations concerning clinical trials

1989 ◽  
Vol 4 (2) ◽  
pp. 117-122 ◽  
Author(s):  
J.-F. Dreyfus ◽  
D. Cremniter ◽  
J.D. Guelfi
Keyword(s):  
Clinical Trials ◽  
Drug Users ◽  
Objective Evaluation ◽  
World Health ◽  
Measuring Instruments ◽  
New Techniques ◽  
The Usa ◽  
The One ◽  
Health Organization

SummaryWe are still confronted by numerous different nosographic models and problems concerning the objective evaluation of patients progress during treatment. It is interesting to consider the consequences of this situation in psychiatry which still involves a relative diversity of practical methods used in clinical trials. The recommendations of the USA Food and Drug Administration, on the one hand, constitute a highly structured and precise reference. The World Health Organization, on the other hand, promulgates general recommendations resulting from a compromise designed to satisfy the greatest number of clinicians.Despite the apparently diverse principles and the different practical methods they propose, both those sets of recommendations have been useful in inspiring clinicians to reflect upon these different methodological approaches. The qualities of the inclusion criteria used in the study of patients and the sensitivity of the different measuring instruments have allowed psychotropic drug users as well as producers to recognize the need for a certain rigour in clinical trials.The FDA and WHO guidelines have certainly improved the quality of clinical trials in psychopharmacology. However, they also represent a source of resistance to innovation.A series of consensus meetings to first reconcile US and European points of view and later to include new techniques in the recognized sets of methods would therefore be helpful.

scholarly journals Evaluation of the quality of life of clients with chronic ischemic pain

2011 ◽  
Vol 19 (1) ◽  
pp. 67-72 ◽  
Author(s):  
Débora Fernanda Amaral Pedrosa ◽  
Andressa Karina Amaral Plá Pelegrin ◽  
Hilze Benigno de Oliveira Moura Siqueira ◽  
Talita de Cássia Raminelli da Silva ◽  
Orlando Carlos Gomes Colhado ◽  
...  
Keyword(s):  
Quality Of Life ◽  
World Health ◽  
Physical Domain ◽  
Ischemic Pain ◽  
World Health Organization Quality ◽  
The Social ◽  
Organization Quality ◽  
The One ◽  
Health Organization

The evaluation of quality of life (QOL) faced with chronic ischemic pain involves the clients in their subjectivity and multidimensionality. This descriptive study aimed to evaluate the quality of life of clients who presented chronic ischemic pain. A total of 100 clients of hospital institutes participated in the study. The instrument used to assess pain was an 11 point numerical scale, and to assess the quality of life, the World Health Organization Quality of Life-abbreviated questionnaire. The arithmetic mean for chronic pain was 5.59±3.16 points. The means for quality of life were: in the physical domain, 44.75±16.98; in the overall domain, 50.0±22.40; in the environment, 55.06±13.51, in the psychological, 56.21±17.19 and in the social domain, 68.33±21.84. Thus, the physical domain was, among the areas analyzed, the one which presented a greater impact on the quality of life of the clients with chronic ischemic pain.

scholarly journals Analysis of the Registration Information on Interventions of Acupuncture and Moxibustion Trials in the International Clinical Trials Registry Platform

2018 ◽  
Vol 2018 ◽  
pp. 1-12 ◽  
Author(s):  
Yali Liu ◽  
Wenjie Chen ◽  
Yingxin Tan ◽  
Xingyue Yang ◽  
Jia Liu ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Sham Acupuncture ◽  
World Health ◽  
Control Group ◽  
Duration Of Treatment ◽  
Acupuncture And Moxibustion ◽  
Health Organization ◽  
Number Of Treatment ◽  
Clinical Trials Registry

Purpose. To analyze and compare the clinical registration information about acupuncture and moxibustion for intervention characteristics. Methods. Clinical trials from the International Clinical Trials Registry Platform of the World Health Organization in acupuncture and moxibustion were comprehensively collected from 2013 to 2015; data were independently screened and extracted by two retrievers, and relevant data involving either basic descriptions or intervention characteristics were analyzed. Results. 425 acupuncture and moxibustion registered clinical trials were included; 88.00% (374/425) were designed as controlled studies, among which 38.59% (164/425) had sham acupuncture as the control group. The most common diseases were pain-related at approximately 19.29% (82/425) of trials. Reports on the intervention information in these acupuncture and moxibustion clinical studies were not sufficiently presented; these reports included the reporting of names of points (39.8%), the method of needle stimulation (32.5%), needle type (29.6%), needle retention time (34.1%), the number of treatment sessions (22.4%), and the frequency and duration of treatment sessions (38.1%). Conclusion. The registration information for the clinical trials of acupuncture and moxibustion was quite low according to this investigational study. Steps should be taken to improve the quality of acupuncture and moxibustion registration information.

scholarly journals QUALIDADE DA ÁGUA UTILIZADA PARA IRRIGAÇÃO DE HORTALIÇAS NA REGIÃO DE BOTUCATU-SP

Irriga ◽  
2007 ◽  
Vol 12 (2) ◽  
pp. 144-155 ◽  
Author(s):  
Ana Maria Morato Fávero de Fravet ◽  
Raimundo Leite Cruz
Keyword(s):  
Public Health ◽  
Water Source ◽  
World Health ◽  
Vegetable Farmers ◽  
Quality Of Water ◽  
Water Classification ◽  
National Environment ◽  
The One ◽  
Health Organization

QUALIDADE DA ÁGUA UTILIZADA PARA IRRIGAÇÃO DE HORTALIÇAS NA REGIÃO DE BOTUCATU-SP  Ana Maria Morato Fávero de Fravet; Raimundo Leite CruzDepartamento de Engenharia Rural, Faculdade de Ciências Agronômicas, Universidade Estadual Paulista, Botucatu, SP, [email protected]  1 RESUMO Objetivou-se com o presente trabalho verificar a qualidade da água utilizada para irrigação por produtores de hortaliças da região de Botucatu-SP.Foram entrevistados 27 produtores que vendem hortaliças nas feiras livres de Botucatu. Dentre estes produtores, foram selecionados dez, sendo um de cada localidade.Foram coletadas três amostras de água de cada fonte. Os principais padrões para avaliar os resultados obtidos foram os da Resolução do CONAMA (Conselho Nacional do Meio Ambiente) N° 357, de 17 de março de 2005, que estabelece os padrões para classificação dos corpos de água.A Condutividade Elétrica foi avaliada segundo valor sugerido pela CETESB e a cor foi verificada conforme a OMS (Organização Mundial da Saúde), para água potável devido a Resolução do CONAMA não estipular um valor para classificação.Para a saúde pública, apenas os coliformes e o nitrato são as variáveis preocupantes por estarem relacionados com a incidência de doenças, assim, das águas analisadas, 40% delas (produtores A, F, H e J) oferecem algum tipo de risco para a saúde da população de Botucatu, segundo padrão estabelecido pelo CONAMA.Podemos concluir que, de maneira geral, essas águas, encontram-se em condições não alarmantes, pois não apresentam valores muito diferentes daqueles estabelecidos pela legislação. UNITERMOS: classificação dos corpos de água, saúde pública, coliformes, nitrato.   FRAVET, A, M. M. F. de; CRUZ R. L. QUALITY OF WATER USED FOR VEGETABLE IRRIGATION IN BOTUCATU AREA  2 ABSTRACT This study aimed to verify the quality of water used for irrigation by vegetable farmers in Botucatu area.27 farmers that sell vegetables in the street markets of Botucatu were interviewed. Among them, ten were selected. Each one was from a different place of the studied area.Three water samples from each water source were collected. In order to evaluate the obtained results, the main used standard was the one used by CONAMA (National Environment Council) resolution No. 357, March 17, 2005, because it establishes the standard for water classification.The Electric conductivity was evaluated according to values suggested by CETESB, but water color was verified according to WHO (World health organization) standard for drinking water because the CONAMA resolution does not determine classification values for that.For public health, just coliforms and nitrate are the preoccupying variables because they are related to the incidence of diseases. 40% of analyzed waters (A, F, H and J farmers) offer some risk to Botucatu population’s health, according to the standard established by CONAMA.We can conclude that in general analyzed waters are in non-alarming conditions and do not present very different values from those established by the legislation. KEYWORDS: water classification, public health, coliforms, nitrate.

scholarly journals The Clinical Trial Landscape for Melanoma Therapies

2019 ◽  
Vol 8 (3) ◽  
pp. 368 ◽  
Author(s):  
Sonia Wróbel ◽  
Małgorzata Przybyło ◽  
Ewa Stępień
Keyword(s):  
Clinical Trials ◽  
Historical Context ◽  
Modern Medicine ◽  
World Health ◽  
Cancer Information ◽  
Data Repositories ◽  
Control And Prevention ◽  
The Usa ◽  
Health Organization ◽  
Clinical Trials Registry

(1) Despite many years of research, melanoma still remains a big challenge for modern medicine. The purpose of this article is to review publicly available clinical trials to find trends regarding the number of trials, their location, and interventions including the most frequently studied drugs and their combinations. (2) We surveyed clinical trials registered in the International Clinical Trials Registry Platform (ICTRP), one of the largest databases on clinical trials. The search was performed on 30 November 2018 using the term “melanoma”. Data have been supplemented with the information obtained from publicly available data repositories including PubMed, World Health Organization, National Cancer Institute, Centers for Disease Control and Prevention, European Cancer Information System, and many others to bring the historical context of this study. (3) Among the total of 2563 clinical trials included in the analysis, most have been registered in the USA (1487), which is 58% of the total. The most commonly studied drug in clinical trials was ipilimumab, described as applied intervention in 251 trials. (4) An increase in the number of melanoma clinical trials using immunomodulating monoclonal antibody therapies, small molecule-targeted therapies (inhibitors of BRAF, MEK, CDK4/6), and combination therapies is recognized. This illustrates the tendency towards precision medicine.

Does a Vote of 118 to 1 Mean the USA Was Wrong?

PEDIATRICS ◽  
1981 ◽  
Vol 68 (3) ◽  
pp. 431-431
Author(s):  
Jerold F. Lucey
Keyword(s):  
United States ◽  
Third World ◽  
The United States ◽  
World Country ◽  
World Health ◽  
Foreign Companies ◽  
Third World Country ◽  
The Usa ◽  
The One ◽  
Health Organization

Picture yourself, a doctor living in a Third World country frustrated by the failure of your efforts to change poverty, malnutrition, and poor sanitation. Little wonder that you would choose to attack rich foreign companies if you thought they contributed to your problems. You would also feel great if the whole world joined you in condemning such companies. When the turmoil had settled, however, and you realized that you may have been wrong, or at least lacked proper evidence, you might not feel so self-righteous. The final vote in the World Health Organization was 118 to 1. The United States was the one! Does that mean that the United States was wrong?

scholarly journals Validation of happiness scale convergence in santri through Multi-trait Multi-method Analysis

2019 ◽  
Vol 4 (2) ◽  
pp. 143
Author(s):  
Rosleny Marliani ◽  
Zulmi Ramdani ◽  
Jam’an Muhamad Hasan Imran
Keyword(s):  
Convergent Validity ◽  
Scale Validation ◽  
World Health ◽  
Measuring Instruments ◽  
World Health Organization Quality ◽  
Organization Quality ◽  
Health Organization ◽  
Convergent Validation ◽  
Method Analysis

<p>Happiness is a concept that is difficult to understand to this date. Differences in individual perspectives in interpreting happiness also affect the processing construct of the measurement. This study aims to conduct convergent validation of the existing happiness scale. Convergent validation can test how good the happiness scale is by comparing the externally to another scale that is considered to have a relationship. The happiness convergent-scale validation adapted the Multi-trait Multi-method (MTMM) analysis. Respondents involved in this study were 186 students from traditional Muslim schools or Santri who were selected according to the specified characteristics and studied at UIN Sunan Gunung Djati Bandung. The three measuring instruments used are the Oxford Happiness Questionnaire (OHQ), the Indigenous Happiness Scale (IHS), and the World Health Organization Quality of Life-Bref (WHOQOL-Bref). The correlation coefficient (r) shows values of 0.52 (OHQ-IHS), 0.53 (OHQ-WHOQOL-Bref), and 0.45 (IHS-WHOQOL-Bref). The result indicated that the correlation of the three scales tested has a statistically high relationship so that the three measuring instruments used have convergent validity and can be used to measure the construct of happiness.</p>

Obstacles to Claiming Permanence and Injury-Relatedness for “Posttraumatic” Headache

2009 ◽  
Vol 14 (3) ◽  
pp. 3-6
Author(s):  
Robert J. Barth
Keyword(s):  
Complete Recovery ◽  
World Health ◽  
Related Factors ◽  
Posttraumatic Headache ◽  
Sixth Edition ◽  
Causative Relationship ◽  
Short Period ◽  
The One ◽  
Health Organization ◽  
Subjective Reports

Abstract “Posttraumatic” headaches claims are controversial because they are subjective reports often provided in the complex of litigation, and the underlying pathogenesis is not defined. This article reviews principles and scientific considerations in the AMAGuides to the Evaluation of Permanent Impairment (AMA Guides) that should be noted by evaluators who examine such cases. Some examples in the AMA Guides, Sixth Edition, may seem to imply that mild head trauma can cause permanent impairment due to headache. The author examines scientific findings that present obstacles to claiming that concussion or mild traumatic brain injury is a cause of permanent headache. The World Health Organization, for example, found a favorable prognosis for posttraumatic headache, and complete recovery over a short period of time was the norm. Other studies have highlighted the lack of a dose-response correlation between trauma and prolonged headache complaints, both in terms of the frequency and the severity of trauma. On the one hand, scientific studies have failed to support the hypothesis of a causative relationship between trauma and permanent or prolonged headaches; on the other hand, non–trauma-related factors are strongly associated with complaints of prolonged headache.

Alexithyme Patientenmerkmale und Lebensqualität – Eine Querschnittsstudie an 79 ambulanten Patienten mit Angststörungen

2013 ◽  
Vol 61 (1) ◽  
pp. 17-26 ◽  
Author(s):  
Katrin Leenen ◽  
Michael Rufer ◽  
Hanspeter Moergeli ◽  
Hans-Jörgen Grabe ◽  
Josef Jenewein ◽  
...  
Keyword(s):  
Quality Of Life ◽  
World Health ◽  
Life Questionnaire ◽  
World Health Organization Quality ◽  
Fand Sich ◽  
Quality Of Life Questionnaire ◽  
Organization Quality ◽  
Health Organization ◽  
Tas 20

Aus Untersuchungen in der Normalbevölkerung ist bekannt, dass Menschen mit erhöhten Alexithymiewerten eine verminderte Lebensqualität (LQ) aufweisen. Für Patienten mit psychischen Störungen wurde dieser Zusammenhang jedoch kaum untersucht. Ziel dieser Studie war es, den möglichen Zusammenhang zwischen alexithymen Patientenmerkmalen und der LQ bei Patienten mit Angststörungen zu überprüfen. Bei 79 ambulanten Patienten mit Angststörungen wurden alexithyme Charakteristika mit der Toronto Alexithymia Scale (TAS-20), die LQ mit der Kurzversion des World Health Organization Quality of Life Questionnaire 100 (WHOQOL-BREF) erfasst. Darüber hinaus fand eine Erhebung der psychischen Symptombelastung (SCL-90-R) und depressiven Symptomatik (MADRS) statt. Mittels hierarchischer Regressionsanalysen wurde der Zusammenhang zwischen der alexithymen Charakteristika und den unterschiedlichen LQ-Domänen berechnet. Die Patienten zeigten eine im Vergleich zur Normalbevölkerung deutlich verminderte LQ. Als Hauptergebnis fand sich, auch nach Kontrolle von Depression, Ängstlichkeit und Geschlecht, ein signifikanter Zusammenhang zwischen den beiden TAS-20 Subskalen Schwierigkeiten, Gefühle zu identifizieren und zu beschreiben und vor allem der psychischen LQ. Unsere Ergebnisse sprechen dafür, bei der Diagnostik und Therapieplanung von Patienten mit Angststörungen alexithyme Merkmale einzubeziehen. Im Falle von ausgeprägten alexithymen Merkmalen sollten psychotherapeutische Interventionen zur Verbesserung der Schwierigkeiten Gefühle wahrzunehmen und zu kommunizieren in Betracht gezogen werden.

Standardization of Factor VIII – IV. Establishment of the 3rd International Standard for Factor VIII: C Concentrate

1983 ◽  
Vol 50 (03) ◽  
pp. 697-702 ◽  
Author(s):  
T W Barrowcliffe ◽  
A D Curtis ◽  
D P Thomas
Keyword(s):  
Factor Viii ◽  
High Purity ◽  
Collaborative Study ◽  
World Health ◽  
Current Standard ◽  
Two Stage ◽  
International Standard ◽  
One Stage ◽  
The One ◽  
Health Organization

SummaryAn international collaborative study was carried out to establish a replacement for the current (2nd) international standard for Factor VIII: C, concentrate. Twenty-six laboratories took part, of which 17 performed one-stage assays, three performed two-stage assays and six used both methods. The proposed new standard, an intermediate purity concentrate, was assayed against the current standard, against a high-purity concentrate and against an International Reference Plasma, coded 80/511, previously calibrated against fresh normal plasma.Assays of the proposed new standard against the current standard gave a mean potency of 3.89 iu/ampoule, with good agreement between laboratories and between one-stage and two- stage assays. There was also no difference between assay methods in the comparison of high-purity and intermediate purity concentrates. In the comparison of the proposed standard with the plasma reference preparation, the overall mean potency was 4.03 iu/ampoule, but there were substantial differences between laboratories, and the two-stage method gave significantly higher results than the one stage method. Of the technical variables in the one-stage method, only the activation time with one reagent appeared to have any influence on the results of this comparison of concentrate against plasma.Accelerated degradation studies showed that the proposed standard is very stable. With the agreement of the participants, the material, in ampoules coded 80/556, has been established by the World Health Organization as the 3rd International Standard for Factor VIII :C, Concentrate, with an assigned potency of 3.9 iu/ampoule.

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