Características de los ensayos clínicos autorizados en el Perú, 1995-2012

Minaya, Gabriela; Fuentes, Duilio; Obregón, Cristian; Quintanilla, Beatriz Paulina Ayala; Yagui, Martín

doi:10.1590/s1726-46342012000400003

Cited by 10 publications

(11 citation statements)

References 7 publications

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“…This was similarly observed in the previous report of REPEC. 12 Also, the financial support from the industry can influence publication bias, trial data, and authorship. 26 Otherwise,…”

Section: Discussionmentioning

confidence: 99%

Twenty‐two years’ experience registering trials in a low‐middle income country: The Peruvian Clinical Trial Registry

Alarcón-Ruiz

Roque‐Roque

Heredia

et al. 2019

J Evidence Based Medicine

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Aim This study analyzes the quantitative and qualitative evolution of the Peruvian Clinical Trial Registry during the last 22 years. Methods Following a cross‐sectional design, we reviewed all clinical trials registered at the Peruvian Clinical Trial Registry during 1995‐2017. We downloaded and extracted all registries on 31 March 2018. We summarized qualitative variables and quantitative variables. Also, we performed trends analysis of the records by year, clinical phase, institutional review board, and children's participation. Results The Peruvian Clinical Trial Registry recorded 1748 clinical trials during 1995‐2017. Considering World Health Organization 20‐standard descriptors as the standard, the registry suitably recorded four of them in 1995 and 19 since 2013. There was a meaningful change in the trend of the registries, showing a significant upward registry trend until 2008 and a significant downward registry trend since then. This trend could be influenced by new regulation in clinical trials registry. Several trials had incomplete entries for different studied variables. Most of the clinical trials (82%) included male and female participants, and only 14% included children. Oncological disorders were the diseases most frequently investigated (20%). Most of clinical trials were registered by pharmaceutical companies. A few institutional review boards evaluated most of the clinical trials. Conclusion The registration of clinical trials in Peru has improved quantitatively and qualitatively since it started, but its quantitative grow stopped in 2008. Since then, the number of registries has declined steadily. There is an influence of pharmaceutical companies in clinical trial registration.

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“…This was similarly observed in the previous report of REPEC. 12 Also, the financial support from the industry can influence publication bias, trial data, and authorship. 26 Otherwise,…”

Section: Discussionmentioning

confidence: 99%

Twenty‐two years’ experience registering trials in a low‐middle income country: The Peruvian Clinical Trial Registry

Alarcón-Ruiz

Roque‐Roque

Heredia

et al. 2019

J Evidence Based Medicine

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“…An important number of studies particularly from Brazil, were funded by public sector in the context of Master and Doctorate programs that tend to be developed by single centers and with limited resources. On the other hand, one recent study, which reviewed all records of clinical trials submitted for review and possible approval by the National Institute of Health (INS) of Peru between 1995 and 2012 found that the transnational pharmaceutical industry was the main sponsor in 87.1% of 1255 approved trials [31].…”

Section: Discussionmentioning

confidence: 99%

Characteristics of Randomized Trials Published in Latin America and the Caribbean According to Funding Source

et al. 2013

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IntroductionFew studies have assessed the nature and quality of randomized controlled trials (RCTs) in Latin America and the Caribbean (LAC).Methods and FindingsThe aims of this systematic review are to evaluate the characteristics (including the risk of bias assessment) of RCT conducted in LAC according to funding source. A review of RCTs published in 2010 in which the author's affiliation was from LAC was performed in PubMed and LILACS. Two reviewers independently extracted data and assessed the risk of bias. The primary outcomes were risk of bias assessment and funding source. A total of 1,695 references were found in PubMed and LILACS databases, of which 526 were RCTs (N = 73.513 participants). English was the dominant publication language (93%) and most of the RCTs were published in non-LAC journals (84.2%). Only five of the 19 identified countries accounted for nearly 95% of all RCTs conducted in the region (Brazil 70.9%, Mexico 10.1%, Argentina 5.9%, Colombia 3.8%, and Chile 3.4%). Few RCTs covered priority areas related with Millennium Development Goals like maternal health (6.7%) or high priority infectious diseases (3.8%). Regarding children, 3.6% and 0.4% RCT evaluated nutrition and diarrhea interventions respectively but none pneumonia. As a comparison, aesthetic and sport related interventions account for 4.6% of all trials. A random sample of RCTs (n = 358) was assessed for funding source: exclusively public (33.8%); private (e.g. pharmaceutical company) (15.3%); other (e.g. mixed, NGO) (15.1%); no funding (35.8%). Overall assessments for risk of bias showed no statistically significant differences between RCTs and type of funding source. Statistically significant differences favoring private and others type of funding was found when assessing trial registration and conflict of interest reporting.ConclusionFindings of this study could be used to provide more direction for future research to facilitate innovation, improve health outcomes or address priority health problems.

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“…Governance of clinical research is often inadequate and systems for reporting research misconduct are rare. As in many low- and middle-income countries, a significant number of clinical trials conducted in the region are multicenter studies, using protocols written in highincome countries, sponsored by foreign funding agencies or multinational pharmaceutical corporations, and often carried out by investigators from foreign institutions (Minaya et al, 2012). Often, little information is returned to the local population from which participants are drawn, and participants may not understand that they are taking part in research.…”

Section: Contextmentioning

confidence: 99%

Twelve Years of Fogarty-Funded Bioethics Training in Latin America and the Caribbean: Achievements and Challenges

Saénz

Heitman

Luna

et al. 2014

Journal of Empirical Research on Human Research Ethics

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The landscape in research ethics has changed significantly in Latin America and the Caribbean over the past two decades. Research ethics has gone from being a largely foreign concept and unfamiliar practice to an integral and growing feature of regional health research systems. Four bioethics training programs have been funded by the Fogarty International Center (FIC) in this region in the past 12 years. Overall, they have contributed significantly to changing the face of research ethics through the creation of locally relevant training materials and courses (including distance learning), academic publications, workshops, and conferences in Spanish, and strengthening ethics review committees and national systems of governance. This paper outlines their achievements and challenges, and reflects on current regional needs and what the future may hold for research ethics and bioethics training in Latin America and the Caribbean.

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Características de los ensayos clínicos autorizados en el Perú, 1995-2012

Cited by 10 publications

References 7 publications

Twenty‐two years’ experience registering trials in a low‐middle income country: The Peruvian Clinical Trial Registry

Twenty‐two years’ experience registering trials in a low‐middle income country: The Peruvian Clinical Trial Registry

Characteristics of Randomized Trials Published in Latin America and the Caribbean According to Funding Source

Twelve Years of Fogarty-Funded Bioethics Training in Latin America and the Caribbean: Achievements and Challenges

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