Implementation of good clinical practice guidelines in vaccine trials in developing countries

Acosta, Camilo J.; Galindo, Claudia; Ochiai, R. Leon; Danovaro-Holliday, M. Carolina; Laure-Page, Anne; Thiem, Vu Dinh; Yang, Jing; Khan, Mohammad Imran; Sahito, Shah Muhammad; Hamza, Hasan Bin; Park, Jin Kyoung; Lee, Hyejon; Bock, Hans L.; Elyazeed, Remon Abu; Albert, M. John; Ascaso, Carlos; Robles, Tonette Q.; Ali, Mohammad; Ngai, Philip; Puri, Mahesh; Koo, Young Mo; Agtini, Magdarina Destri; Soeharno, Rooswanti; Dong, Bin; Kohl, D.; Xu, Zhi; Ivanoff, B; Jódar, Luis; Pang, Tikki; Bhutta, Zulfiqar Ahmed; Clemens, John D.

doi:10.1016/j.vaccine.2006.09.079

Cited by 17 publications

(15 citation statements)

References 9 publications

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“…Another example comes from the Tuskegee trial. 4 This study, which included men with syphilis, was sponsored by a government health agency. In the trial, some of the participants were given treatment and the others had no treatment.…”

Section: History Of Good Clinical Practicementioning

confidence: 99%

“…This resulted in litigation and financial settlements, and a public apology from a very senior government official in an international news network. 4 Another famous example was 'The Harvard Fraud' of the 1980s. 10 In this incident, a prominent senior researcher based at a reknowned institution trained and tutored a student.…”

Section: History Of Good Clinical Practicementioning

confidence: 99%

“…3 The increasing number of trials generated a need to ensure that participants in clinical trials are protected and that the data reported are valid. 4 As a result, a standard international guideline named Good Clinical Practice was developed by the World Health Organization in the mid-1990s for this purpose. 5,6 What is Good Clinical Practice (GCP)?…”

Section: Introductionmentioning

confidence: 99%

“…4 It also requires research to exhibit 'fairness', meaning that the research should not be offered to only some patients or select only 'undesirable' persons for risky research. Thus, these ethical principles safeguard both the able and vulnerable groups.…”

mentioning

confidence: 99%

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The need for ‘Good Clinical Practice’ in health care research

Mhr

Aziz

et al. 2009

South African Family Practice

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Randomised controlled trials form the foundation for 'evidence-based-medicine', but the results of such research can be relied upon only if it was conducted according to principles and standards collectively referred to as 'Good Clinical Practice' (GCP). The GCP was established as a basis both for the scientific and ethical integrity of research involving human subjects and for generating valid observations and sound documentation of research findings. It provides a framework for clinical investigators and pharmaceutical companies to conduct clinical trials according to similar rules and regulations, to ensure clinical research is consistently performed to high ethical and scientific standards and an assurance that the data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of trial subjects are protected. Thus the GCP protects the rights, safety and well-being of subjects and ensures that investigations are scientifically sound and advance public health goals.This article has been peer reviewed.

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Section: History Of Good Clinical Practicementioning

confidence: 99%

Section: History Of Good Clinical Practicementioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

mentioning

confidence: 99%

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The need for ‘Good Clinical Practice’ in health care research

Mhr

Aziz

et al. 2009

South African Family Practice

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“…While new medical products (drugs and vaccines) are being developed and asking for registration, their efficacy and safety should be assessed in a well-designed clinical trial, ultimately on human beings [1]. This process is costly, and ethical considerations are controversial.…”

Section: Introductionmentioning

confidence: 99%

Good Clinical Practice in Children and Adolescents

Mohammadi¹,

Mostafavi²

2018

Clinical Trials in Vulnerable Populations

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Good clinical practice (GCP) is a series of systematically developed ethical and quality standard of designing, registering, running, recording, and reporting of the clinical trials. Good clinical practice is very important regarding the trials usually performed on the vulnerable populations especially children and adolescents. The sensitivity of the issue is even higher in the children with psychiatric disorders. Usually, these children have little legal protection. Hence, the safety of interventions and the ethical considerations are among the most important issues in this field. The purpose of this chapter is to deal with above problems and globally applicable standards for the conduct of clinical trials on the under legal age subjects especially those with psychiatric disorders. Selection of trial subjects, ethical principles, regulatory requirements, protection of trial subjects, monitoring (compliance with the protocol), responsibilities of the investigator, and other requirements to perform a clinically and ethically sound clinical trial in children and adolescents will be discussed in this chapter.

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