Hospital training program increases awareness of Good Clinical Practice (GCP)

Kuusisto, Hanna; Virkki, Marjo; Wuolijoki, Erkki; Keränen, Tapani

doi:10.1016/j.cct.2011.01.011

Cited by 10 publications

(5 citation statements)

References 6 publications

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“…37 The key issue to reducing tension between the regulations and clinical research practice is to ensure that researchers and clinical staff have adequate research ethics training and knowledge of the regulations and legislation. 13,38,39 According to previous studies, greater knowledge of ethical norms may be associated with better critical reasoning. 40,41 In addition, the ethical sensitivity and reflection skills of researchers and clinical staff should be strengthened.…”

Section: Discussionmentioning

confidence: 92%

What enables ethically conducted clinical research in hospitals? Views of the administrative staff

et al. 2016

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Background: Administrative staff, including principal investigators, administrative managers, and elected officials, have a crucial role in ensuring the ethical conduct of the clinical research that occurs in their organisations. However, only few studies have focused on their perspectives. Aim: This study describes the ethical aspects of clinical research from the perspectives of the administrative staff at university hospitals in Finland. Methods: Qualitative data were collected with semi-structured face-to-face interviews (n ¼ 31), and subjected to content analysis. Results: Four core perspectives emerged: human subject autonomy and its acknowledgement in clinical practice, increased tension between the regulations and practice of clinical research, concerns about a changing research environment, and factors that promote ethical research conduct in hospitals. Conclusion: Ethics always extends beyond the law. Therefore it is important to strengthen researchers' ethical sensitivity through education. Furthermore, we should reinforce elements such as organisational culture, cooperation, and a workable research infrastructure that support good research ethics in hospitals.

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Section: Discussionmentioning

confidence: 92%

What enables ethically conducted clinical research in hospitals? Views of the administrative staff

et al. 2016

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“…We suggest the addition of a course on GCP in the curriculum of undergraduates and post-graduates to familiarize individuals with clinical research. Interactive training sessions can also be held, which have been shown to be effective by some studies[ 8 , 13 , 14 ].…”

Section: Discussionmentioning

confidence: 99%

Study on good clinical practices among researchers in a tertiary healthcare institute in India

Harshita,

Panda

2023

World J Methodol

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BACKGROUND Good clinical practice (GCP) is put in place to protect human participants in clinical trials as well as to ensure the quality of research. Non-adherence to these guidelines can produce research that may not meet the standards set by the scientific community. Therefore, it must be ensured that researchers are well-versed in the GCP. But not much is known about the knowledge and practices of the GCP in the medical colleges of North India. AIM To assess the knowledge and practices of researchers about GCP and analyze these with respect to the demographics of participants. METHODS This is a cross-sectional study. A self-structured questionnaire about GCP, after expert validations, was circulated among researchers, at a tertiary healthcare institute, All India Institute of Medical Sciences (AIIMS), Rishikesh. A total of 59 individuals, who were selected by universal sampling, participated in the study. All healthcare workers who have been investigators of Institutional Ethics Committee-approved research projects, except residents and faculty, and are still a part of the institute have been included in the study. The study was approved by the Institutional Ethics Committee of AIIMS, Rishikesh. We used descriptive analysis and the Chi-squared test to analyze data. P value < 0.05 was considered significant. RESULTS Out of 59 participants, only 11 (18.6%) were certified for GCP. Most of the participants (64.4%) had “Average” knowledge, 33.9% had “Good” knowledge and 1.7% had “Poor” knowledge. Only 49% of participants had satisfactory practices related to GCP. There was a significant difference in the knowledge based on the current academic position for the items assessing knowledge of institutional review board (P = 0.010), confidentiality & privacy (P = 0.011), and participant safety & adverse events (P < 0.001). There was also a significant difference in knowledge of research misconduct (P = 0.024) and participant safety & adverse events (P = 0.011) based on certification of GCP. There was a notable difference in the practices related to recruitment & retention on the basis of current academic position (P < 0.001) and certification of GCP (P = 0.023). We also observed a considerable difference between the knowledge and practices of GCP among the participants (P = 0.013). CONCLUSION Participants have basic knowledge of GCP but show a lack thereof in certain domains of GCP. This can be addressed by holding training sessions focusing on these particular domains.

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“…Pharmaceutical companies and journal editors have made recommendations on AEs (including SAE) reporting after a thorough discussion on how policies and guidelines were followed, what challenges existed, and how challenges should be addressed to improve AEs and SAEs reporting in clinical research publications to enhance the degree of authenticity and accuracy of clinical trial data ( Lineberry et al, 2016 ). Third, the training recommendations in the Good Clinical Practice (GCP) guidelines require investigators and study coordinators executing a clinical trial to undergo training on GCP principles every 3 years ( Shanley et al, 2017 ), enhancing investigators’ compliance with GCP ( Kuusisto et al, 2011 ). Finally, SAEs reports are processed by an automated computer system instead of personal reports with the development of information technology, saving workforce resources and time and facilitating the analysis of reporting performance and the nature of SAEs reports ( London et al, 2009 ; Pecoraro and Luzi, 2011 ).…”

Section: Discussionmentioning

confidence: 99%

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

et al. 2021

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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 < 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.

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Hospital training program increases awareness of Good Clinical Practice (GCP)

Cited by 10 publications

References 6 publications

What enables ethically conducted clinical research in hospitals? Views of the administrative staff

What enables ethically conducted clinical research in hospitals? Views of the administrative staff

Study on good clinical practices among researchers in a tertiary healthcare institute in India

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

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