A call for improved transparency in financial aspects of clinical trials: a case study of the CREATE-X trial in the New England Journal of Medicine

2018 ◽  
Vol 36 (3) ◽  
pp. 517-522 ◽  
Author(s):  
Akihiko Ozaki ◽  
Morihito Takita ◽  
Tetsuya Tanimoto
Keyword(s):  
Clinical Trials ◽  
England Journal ◽  
New England

scholarly journals Subversive Subjects: Rule-Breaking and Deception in Clinical Trials

2013 ◽  
Vol 41 (4) ◽  
pp. 829-840 ◽  
Author(s):  
Rebecca Dresser
Keyword(s):  
Clinical Trials ◽  
England Journal ◽  
Clinical Research ◽  
New England ◽  
Research Team ◽  
Research Subjects ◽  
Study Participation ◽  
Population Number ◽  
Rule Breaking ◽  
Hiv Aids

Scientific reports about clinical research appear objective and straightforward. They describe a study's findings, methods, subject population, number of subjects, and contribution to existing knowledge. The overall picture is pristine: the research team establishes the requirements of study participation and subjects conform to these requirements. Readers are left with the impression that everything was done correctly, by the book.In other places, however, one finds a different and messier picture of clinical research. In this picture, research subjects deviate from the prescribed plan. One author contrasted the “tidy graphics” and “crisp prose” of the New England Journal of Medicine's HIV/AIDS trial publications with reports that subjects shared medications and broke other trial rules. Awareness of this behavior, he wrote, could lead insiders to “conclude that knowledge was resting on something rather less solid than bedrock.”

scholarly journals A systematic review of subgroup analyses in randomised clinical trials in cardiovascular disease

2021 ◽  
pp. 174077452098486
Author(s):  
Korbinian J Brand ◽  
Alexander Hapfelmeier ◽  
Bernhard Haller
Keyword(s):  
Systematic Review ◽  
Cardiovascular Disease ◽  
Clinical Trials ◽  
England Journal ◽  
New England ◽  
Statistical Significance ◽  
Randomised Clinical Trials ◽  
Primary Analysis ◽  
Subgroup Analyses ◽  
Trial Protocols

Background: Subgroup analyses are frequently used to assess heterogeneity of treatment effects in randomised clinical trials. Inconsistent, improper and incomplete implementation, reporting and interpretation have been identified as ongoing challenges. Further, subgroup analyses were frequently criticised because of unreliable or potentially misleading results. More recently, recommendations and guidelines have been provided to improve the reporting of data in this regard. Methods: This systematic review was based on a literature search within the digital archives of three selected medical journals, The New England Journal of Medicine, The Lancet and Circulation. We reviewed articles of randomised clinical trials in the domain of cardiovascular disease which were published in 2015 and 2016. We screened and evaluated the selected articles for the mode of implementation and reporting of subgroup analyses. Results: We were able to identify a total of 130 eligible publications of randomised clinical trials. In 89/130 (68%) articles, results of at least one subgroup analysis were presented. This was dependent on the considered journal (p < 0.001), the number of included patients (p < 0.001) and the lack of statistical significance of a trial’s primary analysis (p < 0.001). The number of reported subgroup analyses ranged from 1 to 101 (median = 13). We were able to comprehend the specification time of reported subgroup analyses for 71/89 (80%) articles, with 55/89 (62%) articles presenting exclusively pre-specified analyses. This information was not always traceable on the basis of provided trial protocols and often did not include the pre-definition of cut-off values for the categorization of subgroups. The use of interaction tests was reported in 84/89 (94%) articles, with 36/89 (40%) articles reporting heterogeneity of the treatment effect for at least one primary or secondary trial outcome. Subgroup analyses were reported more frequently for larger randomised clinical trials, and if primary analyses did not reach statistical significance. Information about the implementation of subgroup analyses was reported most consistently for articles from The New England Journal of Medicine, since it was also traceable on the basis of provided trial protocols. We were able to comprehend whether subgroup analyses were pre-specified in a majority of the reviewed publications. Even though results of multiple subgroup analyses were reported for most published trials, a corresponding adjustment for multiple testing was rarely considered. Conclusion: Compared to previous reviews in this context, we observed improvements in the reporting of subgroup analyses of cardiovascular randomised clinical trials. Nonetheless, critical shortcomings, such as inconsistent reporting of the implementation and insufficient pre-specification, persist.

scholarly journals Food, Micronutrients, and Psychiatry

2002 ◽  
Vol 14 (4) ◽  
pp. 331-334 ◽  
Author(s):  
David F. Horrobin
Keyword(s):  
Clinical Trials ◽  
British Journal ◽  
England Journal ◽  
New England ◽  
Mentally Ill ◽  
Affective Disorders ◽  
Epidemiological Studies ◽  
Research Journal ◽  
General Psychiatry

Nutritional biochemistry is not a subject with which most psychiatrists, psychologists, and psychopharmacologists are familiar. A stream of recent epidemiological studies and clinical trials, however, indicates that understanding of nutritional biochemistry is soon going to be essential for anyone working with mentally ill patients. Those who are tempted to dismiss this statement as airy-fairy holistic nonsense will benefit from reading some recent issues of the American Journal of Psychiatry, British Journal of Psychiatry, Archives of General Psychiatry, Schizophrenia Research, Journal of Affective Disorders, and New England Journal of Medicine.

scholarly journals A “indústria dos ensaios clínicos” e sua repercussão sobre a prática médica contemporânea

2001 ◽  
Vol 4 (1) ◽  
pp. 125-136
Author(s):  
Erney Plessmann de Camargo ◽  
Mônica Teixeira
Keyword(s):  
Clinical Trials ◽  
England Journal ◽  
New England

Este artigo relata a maneira pela qual a indústria farmacêutica organiza a experimentação de novas drogas em seres humanos, tal como vem ocorrendo a partir do início da última década do século 20 nos Estados Unidos. Ao fazê-lo, situa aspectos econômicos da produção de fármacos, e sua extraordinária expansão que é uma característica da contemporaneidade. Descreve também práticas tradicionais da clínica médica relacionadas aos ensaios clínicos, em especial as regras éticas aceitas internacionalmente para a investigação médica quando envolve pessoas, estabelecidas depois do horror suscitado pela divulgação dos “experimentos” de médicos nos campos de concentração nazistas. O artigo retrata parte do debate que o surgimento e a consolidação da “indústria dos ensaios clínicos” – clinical trials industry – suscita entre profissionais ligados à prática da medicina, revelado nas revistas The Lancet e New England Journal of Medicine e em relatórios de órgãos de supervisão do governo norte-americano. Conflito de interesses, má conduta científica, o desrespeito ao princípio ético primum non nocere e à regra do consentimento informado dos voluntários que participam de ensaios ocupam o centro das preocupações levantadas por esses profissionais.

scholarly journals La aplicación del conocimiento

2017 ◽  
Vol 42 (3) ◽  
pp. 204-205
Author(s):  
Carlos A Torres Duque ◽  
Maria José Pareja Zabala
Keyword(s):  
Clinical Trials ◽  
England Journal ◽  
New England

Muy importante y bien documentado su Editorial, “La aplicación del conocimiento” (1), en el cual analiza un estudio publicado recientemente en New England Journal of Medicine sobre el uso de oxígeno en pacientes con EPOC e hipoxemia moderada (2) y su dudosa aplicabilidad a grandes alturas, y hace énfasis en la necesidad de investigar localmente acerca de problemas cotidianos en salud. El ejemplo es muy apropiado puesto que los criterios de oxigenoterapia a largo plazo (OLP) en pacientes con EPOC fueron definidos a nivel del mar y cerca del 20% de la población colombiana reside por encima de los 2.500 metros. Al respecto, aportamos la siguiente información: 1. Una de las clasificaciones de altitud más recomendadas (3) define grandes alturas como aquéllas situadas entre 2.500 y 3.500 metros sobre el nivel del mar. Bogotá, a 2.640 metros, es la ciudad más poblada del mundo situada a gran altura (México D.F. está a 2.240 m). 2. El estudio sobre valores normales de gases arteriales en adultos sanos en Bogotá (n=374) (4), en preparación para publicación, muestra que una saturación de oxígeno entre 89 y 93%, definida como hipoxemia moderada en el estudio analizado en su Editorial (1, 2), está en rangos de normalidad para la altitud de Bogotá. 3. Como usted lo plantea (1), se desconoce si los criterios de OLP en EPOC definidos a nivel del mar son apropiados a gran altura. Basados en el estudio sobre gases arteriales normales en Bogotá (4) y en la observación de que un grupo significativo de pacientes con EPOC, residentes a esta altura, con presión arterial de oxígeno entre 50 y 55 mmHg no exhiben signos de hipoxia crónica, particularmente hipertensión pulmonar, planteamos un estudio experimental multicéntrico, coordinado desde la Fundación Neumológica Colombiana, para evaluar si se puede hacer un ajuste (punto de corte más bajo) de los criterios de OLP a gran altura (≥ 2.500 - ≤ 3.500 m). El estudio fue aprobado a comienzos de 2016 por COLCIENCIAS (335972553295) y se encuentra registrado en Clinical Trials (www.clinicaltrials.gov) (NCT03020212). Tendrá una duración de 36 meses y se espera que a comienzos de la siguiente década se tengan resultados que den respuesta a la pregunta planteada en su Editorial. 4. Como información relacionada, un análisis colaborativo (BOLD, PLATINO, EPISCAN y PREPOCOL) recientemente publicado, comprueba que no hay asociación entre altitud y prevalencia de EPOC (5) como lo había sugerido el estudio PREPOCOL previamente.

scholarly journals Publication bias in clinical trials

2009 ◽  
Author(s):  
Martin Fenner
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
England Journal ◽  
New England ◽  
Cancer Patients ◽  
Publication Bias ◽  
Secondary Outcome ◽  
Selective Outcome Reporting ◽  
Outcome Reporting

Last week the New England Journal of Medicine (NEJM) published a paper on selective outcome reporting in clinical trials (Vedula et al. 2009). The primary and secondary outcome(s) of a clinical trial could for example be survival in cancer patients or ...

scholarly journals Serious Adverse Events Reporting in Phase III Randomized Clinical Trials of Colorectal Cancer Treatments: A Systematic Analysis

2021 ◽  
Vol 12 ◽  
Author(s):  
Yanhong Yao ◽  
Zhentao Liu ◽  
Hua Zhang ◽  
Jian Li ◽  
Zhi Peng ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Clinical Trials ◽  
Logistic Regression ◽  
England Journal ◽  
New England ◽  
Randomized Clinical Trials ◽  
Binary Logistic Regression ◽  
Phase Iii ◽  
Cancer Treatments ◽  
Serious Adverse Events

Objective: The occurrence, development, and prognosis of serious adverse events (SAEs) associated with anticancer drugs in clinical trials have important guiding significance for real-world clinical applications. However, to date, there have been no studies investigating SAEs reporting in randomized clinical trials of colorectal cancer treatments. This article systematically reviewed the SAEs reporting of phase III randomized clinical trials of colorectal cancer treatments and analyzed the influencing factors.Methods: We reviewed all articles about phase III randomized clinical trials of colorectal cancer treatments published in the PubMed, Embase, Medline, and New England Journal of Medicine databases from January 1, 1993, to December 31, 2018, and searched the registration information of clinical trials via the internet sites such as “clinicaltrials.gov”. We analyzed the correlation between the reported proportion (RP) of SAEs in the literature and nine elements, including the clinical trial sponsor and the publication time. Chi-square tests and binary logistic regression were used to identify the factors associated with improved SAEs reports. This study was registered on PROSPERO.Results: Of 1560 articles identified, 160 were eligible, with an RP of SAEs of 25.5% (41/160). In forty-one publications reporting SAEs, only 14.6% (6/41) described the pattern of SAEs in detail. In clinical trials sponsored by pharmaceutical companies, the RP of SAEs was significantly higher than that in those sponsored by investigators (57.6 versus 20.7%, p &lt; 0.001). From 1993 to 2018, the RP of SAEs gradually increased (none (0/6) before 2000, 17.1% (12/70) from 2000 to 2009, and 34.5% (29/84) after 2009). The average RP of SAEs published in the New England Journal of Medicine (N Engl J Med), the Lancet, the Journal of the American Medical Association (JAMA), the Lancet Oncology (Lancet Oncol), and the Journal of Clinical Oncology (J Clin Oncol) was significantly higher than that published in other journals (31.9 versus 16.7%, p = 0.030). In the clinical trials referenced by clinical guidelines, the RP of SAEs was higher than that in non-referenced clinical trials (32.0 versus 15.9%, p = 0.023). Binary logistic regression analysis showed that pharmaceutical company sponsorship, new drug research, and sample size greater than 1000 were positive influencing factors for SAEs reporting.Conclusion: Although the RP of SAEs increased over time, SAEs reporting in clinical trials needs to be further improved. The performance, outcomes and prognosis of SAEs should be reported in detail to guide clinical practice in the real world.

Molekularbiologie

2018 ◽  
Vol 09 (05) ◽  
pp. 242-243
Author(s):  
Dr. Susanne Krome
Keyword(s):  
England Journal ◽  
Medical School ◽  
New England ◽  
Harvard Medical School

Zehntausende nichtproteinkodierende RNAs haben die Kenntnisse über die normale Physiologie sowie die Entstehung und Behandlung von Krankheiten auf den Kopf gestellt, schreibt Prof. Frank Slack, Harvard Medical School, Boston/USA, im New England Journal of Medicine über den überwiegenden Teil unseres Genoms. Diese RNA-Sub typen regulieren Wachstum, Entwicklung und Organfunktion. Ihre Gewebespezifität eröffnet neue, unerwartete Möglichkeiten in der Onkologie. Der größte Teil ihrer Funktionen ist allerdings noch nicht erforscht.

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