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.”

The Ethical Challenges of Animal Research

2015 ◽  
Vol 24 (4) ◽  
pp. 391-406 ◽  
Author(s):  
HOPE R. FERDOWSIAN ◽  
JOHN P. GLUCK
Keyword(s):  
England Journal ◽  
Informed Consent ◽  
New England ◽  
Animal Research ◽  
Ethical Challenges ◽  
Research Subjects ◽  
Human Research ◽  
Ethical Justification ◽  
Influential Paper ◽  
Moral Problems

Abstract:In 1966, Henry K. Beecher published an article entitled “Ethics and Clinical Research” in the New England Journal of Medicine, which cited examples of ethically problematic human research. His influential paper drew attention to common moral problems such as inadequate attention to informed consent, risks, and efforts to provide ethical justification. Beecher’s paper provoked significant advancements in human research policies and practices. In this paper, we use an approach modeled after Beecher’s 1966 paper to show that moral problems with animal research are similar to the problems Beecher described for human research. We describe cases that illustrate ethical deficiencies in the conduct of animal research, including inattention to the issue of consent or assent, incomplete surveys of the harms caused by specific protocols, inequitable burdens on research subjects in the absence of benefits to them, and insufficient efforts to provide ethical justification. We provide a set of recommendations to begin to address these deficits.

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.

The Hidden World of Subjects

2016 ◽  
Author(s):  
Rebecca Dresser
Keyword(s):  
Clinical Trials ◽  
Clinical Research ◽  
Research Environment ◽  
Ethical Problems ◽  
Research Results ◽  
Partnership Model ◽  
Fertile Ground ◽  
Rule Breaking ◽  
Personal Interests ◽  
Ethical Responsibilities

This chapter looks at subjects’ concealed misbehavior in research. When their personal interests conflict with the demands of participation, some subjects put their own interests first. They don’t follow study requirements and try to hide this fact from researchers. In rejecting the restrictions research imposes, subjects diminish the value of research results. They create risks to themselves and others; they also disregard ethical responsibilities to adhere to research agreements and tell the truth. At the same time, rule-breaking subjects expose ethical problems in the design and conduct of clinical trials. Features of the research environment create fertile ground for concealed rule-breaking. Intensified policing and guidance are two common strategies for reducing subject misbehavior, but collaborative reforms are more consistent with the partnership model of clinical research.

scholarly journals The Critical Role of the Clinical Research Coordinator for Clinical Trials: A Survey in Oncology

2017 ◽  
Vol 1 ◽  
pp. maapoc.0000015 ◽  
Author(s):  
Margherita Cinefra ◽  
Celeste Cagnazzo ◽  
Laura McMahon ◽  
Francesca Arizio ◽  
Sara Campora ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Clinical Research ◽  
Clinical Studies ◽  
Research Team ◽  
Critical Role ◽  
Strong Support ◽  
Web Survey ◽  
Clinical Research Coordinator ◽  
Research Activities ◽  
Research Coordinator

Introduction Access to innovative medicine requires proper evidence from clinical trials with the growing demand of qualified and experienced personnel. The clinical research coordinator (CRC) plays an important role in the conduction of research activities and provides a strong support to the research team. In Italy, this role is not recognized at any institutional level and its professional outline is still indefinite. Several national associations (Associazione Italiana di Oncologia Medica, Collegio Italiano dei Primari Oncologi Medici Ospedalieri, Gruppo Italiano Data Manager) are committed to promoting the enhancement and recognition of the professional status of CRCs, underlining their role as fundamental. Methods A web survey, proposed by the AIOM CRC Working Group, was submitted to 319 Italian oncology sites with items focusing on the organization of sites, the research activities, the staff composition, and the presence of coordinators and the multidisciplinary team. Results A total of 115 sites (35.9%) responded to the web survey. Clinical studies were carried out at 88.7% of the investigated sites, and coordinators were on staff at 75.5% of the active investigational sites. Interestingly, there was a direct association between the number of clinical studies and the number of coordinators, whose contribution to the research activities is believed to be essential for trial conduct in 82.4% of cases. Most sites retain that the quality of clinical research has absolutely improved (83.3%) after the implementation of a coordinator as member of the team. Conclusions Given the constant growth of the number of clinical trials performed at Italian oncology sites, the CRC proves to be an essential component of the research team. However, there is an urgent need to institute the professional role alongside the need to standardize the training of coordinators to establish the minimum requirements enhanced by qualifying courses.

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 Assessing the challenges of multi-scope clinical research sites: an example from NIH HIV/AIDS clinical trials networks

2013 ◽  
Vol 20 (2) ◽  
pp. 149-157 ◽  
Author(s):  
Scott R. Rosas ◽  
Marie T. Cope ◽  
Christie Villa ◽  
Mahnaz Motevalli ◽  
Jill Utech ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Clinical Research ◽  
Aids Clinical Trials ◽  
Hiv Aids

SCIENTIFIC PUBLICATION

PEDIATRICS ◽  
1978 ◽  
Vol 62 (2) ◽  
pp. 204-204
Author(s):  
A. S. Relman
Keyword(s):  
England Journal ◽  
Clinical Study ◽  
New England ◽  
Research Team ◽  
Scientific Publication ◽  
Ongoing Research ◽  
Communications System ◽  
Initial Results ◽  
Great Mass

Dr. Kan of Ciba-Geigy [was quoted] as saying that the Anturane Research Team used The New England Journal of Medicine as a "court of last resort" in deciding whether to continue their clinical study of the drug after initial results appeared to be so favorable.... This seems to me to reflect a serious misunderstanding of the role of a scientific publication like The New England Journal of Medicine.... We make no claim to editorial omniscience, nor do we guarantee that everything we publish will stand the test of time. Indeed, we know that ideas are being continuously reshaped in the crucible of ongoing research and clinical experience. Good journals try to facilitate this process by identifying noteworthy contributions from among the great mass of material that now overloads our scientific communications system. Everyone should understand, however, that this evaluative function is not quite the same thing as endorsement.

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