Data management in clinical research: An overview

Krishnankutty, Binny; Bellary, Shantala; Kumar, BR Naveen; Moodahadu, Latha Subramanya

doi:10.4103/0253-7613.93842

Cited by 128 publications

(116 citation statements)

References 6 publications

(6 reference statements)

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“…Clinical data are one of most valuable assets for sponsor research and pharmaceutical product manufactures. CDM is a critical phase in clinical research, which leads to generation of high-quality, reliable, and statistically sound data from the clinical trials [7]. The clinical trial can be conducted in one or multi-center research trial, and during the clinical trial, the investigator collects the data in the patients.…”

Section: Data Management In Clinical Trialsmentioning

confidence: 99%

Clinical Data Management Importance in Clinical Research

Murugesan¹,

Banerjee²,

Kumar³

2016

Asian J Pharm Clin Res

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Over the last few decades, most of the pharmaceutical companies and research sponsors are facing a lot of challenges in clinical research for their new drug approval. The sponsor research needs a high-quality data report for getting new drug approval from Food and Drug Administration for their medical products. Clinical trial data are important for the drug and medical device development processing pharmaceutical companies to examine and evaluate the efficacy and safety of the new medical product in human volunteers. The results of the clinical trial studies generate the most valuable data and in recent years; there has been massive development in the field of clinical trials. A good clinical data management system reduces the duration of the study and cost of drug development. Further a well-designed case report form (CRF) assists data collection and make facilitates data management and statistical analysis. Nowadays, the electronic data capture (EDC) is very beneficial in data collection. EDC helps to speed up the clinical trial process and reduces the duration, errors and make the work easy in the data management system. This article highlights the importance of data management processes involved in the clinical trial and provides an overview of the clinical trial data management tools. The study concluded that data management tools play a key role in the clinical trial and well-designed CRFs reduces the errors and save the time of the clinical trials and facilitates the drug discovery and development.

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Section: Data Management In Clinical Trialsmentioning

confidence: 99%

Clinical Data Management Importance in Clinical Research

Murugesan¹,

Banerjee²,

Kumar³

2016

Asian J Pharm Clin Res

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“…On the other hand, central statistical monitoring (CSM) reduces the need for regular on-site monitoring visits [31,32]. CSM could be done at prespecified, fixed intervals at the research coordinating center with a small team and has been found to be an efficient and cost-effective option for tracing data errors which could be completely unintentional resulting from carelessness, fabricated data or falsified data to obtain a desired objective [33,34]. The US FDA and EMA also encourage greater reliance on CSM.…”

Section: Site Monitoring Visitsmentioning

confidence: 99%

Solving clinical trial delays: innovative solutions

Singh¹,

Salam²,

Devarajan³

et al. 2015

Clinical Investigation

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Our objective was to provide broad perspective on causes and consequences of clinical trial delays and suggest process-oriented and technology-enabled pragmatic solutions to minimize trial delays, in particular context of doing trials in India. The main challenges for successful completion of clinical trials stem from regulatory and ethics review, investigator selection, site initiations, participant recruitment and retention, monitoring and data management issues. Careful planning, sorting out ownership issues in the initial steps and a partnership based on shared issues among all the stakeholders will help reduce the trial delays. Such a shared vision will enable adherence to regulatory requirements, enhance the quality of trial conduct and ultimately enable improved access to new treatments and its benefits to the Indian population.

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“…Por ello los datos necesitan ser constantemente monitoreados durante el estudio y se debe recolectar el máxi-mo de datos posibles para su análisis. 54 La introducción de nuevas tecnologías en el proceso de administración de datos ha reducido significativamente los errores que se producían al recolectarlos mediante los FRC al sustituirlos por los FRC electrónicos. Actualmente se utilizan los denominados Sistemas de Administración de Datos Clínicos (CDMS -Clinical Data Management Systems).…”

Section: Administración De Datosunclassified

Consideraciones metodológicas y éticas para la conducción de ensayos clínicos controlados aleatorizados (ECCA) sobre intervenciones para las adicciones

Marín-Navarrete

Fernández-Mondragón

Eliosa-Hernández

et al. 2013

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SUMMARYAccording to epidemiologic reports, the harmful use of alcohol and illicit drugs has increased among the Mexican population. This use is associated to several risks and issues that affect public health and the public well-being of the country. In this article it is acknowledged the need for development of treatment models and interventions whose therapeutic value is demonstrated by scientific evidence, that respond to the attention needs of the population affected by substance use in our country and that can be generalized in community clinical practice.In clinical research, randomized controlled clinical trials (RCT's) are the "gold standard" to demonstrate the effect of a therapeutic intervention. A randomized controlled clinical trial is a prospective study in which the effect, value and safety of one or various experimental interventions are tested against a "control" intervention in human subjects.Acknowledging that in Mexico there is a lack of research on addiction treatment that is compliant with all the requirements to be considered as an RCT, this article presents some methodological and ethical considerations that are neccesary for their design and conduction. These considerations include from the establishment of a relevant research question and objectives, adequate study design, development of strategies for data management, statistical analysis, monitoring of interventions, safety monitoring and research quality assurance and protection of human subjects.Key words: Substance use disorders, treatment, controlled clinical trials, randomized clinical trials, methodology, ethical aspects. RESUMENSegún reportes epidemiológicos, el consumo nocivo de alcohol y drogas ilegales dentro de la población mexicana ha ido en aumento, lo que se asocia a varios riesgos o problemáticas que afectan la salud y bienestar públicos del país. Se reconoce la necesidad de desarrollar modelos de tratamiento e intervenciones cuyo valor terapéutico esté respaldado por la evidencia científica, que respondan a las necesidades de atención de la población afectada por el consumo de sustancias en nuestro país y que puedan generalizarse en la práctica clínica comunitaria.Dentro de la investigación clínica, el "estándar de oro" para demostrar el efecto de una intervención terapéutica son los ensayos clínicos controlados aleatorizados (ECCA). Un ECCA es un estudio prospectivo en el cual se prueba el efecto, valor y seguridad de una o varias intervenciones experimentales contra una intervención "control" en sujetos humanos.Reconociendo que en México hay una falta de investigaciones sobre tratamientos para las adicciones que cumplan con todos los requisitos para ser considerados ECCA, en este artículo se presentan distintas consideraciones metodológicas y éticas que deben tomarse en cuenta para su diseño y conducción en la materia; abarcando aspectos que parten desde el establecimiento de una pregunta y objetivos relevantes hasta el diseño adecuado del estudio y el desarrollo de estrategias para la administración de datos, análisi...

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Data management in clinical research: An overview

Cited by 128 publications

References 6 publications

Clinical Data Management Importance in Clinical Research

Clinical Data Management Importance in Clinical Research

Solving clinical trial delays: innovative solutions

Consideraciones metodológicas y éticas para la conducción de ensayos clínicos controlados aleatorizados (ECCA) sobre intervenciones para las adicciones

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