Clinical trial registration: looking back and moving ahead

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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“…Publicly dissemination of RCTs' information among clinicians, researchers, and patients is an international statement. 30…”

Section: Ranakawa Et Al Describe That Most Rcts Registered In Sri Lanmentioning

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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“…In 2004, ICMJE announced that 11 member journals would require trial registration in a public trial registry. The public registry must meet the following 13 criteria: (1) a unique identifying number, (2) a statement of the intervention (or interventions) and comparison (or comparisons) studied, (3) a statement of the study hypothesis, (4) definitions of the primary and secondary outcome measures, (5) eligibility criteria, (6) key trial dates (registration date, anticipated or actual start date, anticipated or actual date of last follow-up, planned or actual date of closure to data entry, and date trial data considered complete), (7) target number of subjects, (8) funding source, (9) contact information for the principal investigator, (10) the registry must be accessible to the public at no charge, (11) it must be open to all prospective registrants and managed by a not-for-profit organization, (12) there must be a mechanism to ensure the validity of the registration data, and (13) the registry should be electronically searchable (4). At that time, only www.clinicaltrials.gov, sponsored by the United States National Library of Medicine, met these requirements.…”

Section: Introductionmentioning

confidence: 99%

Assessment of registration quality of trials sponsored by China

Liu

Li²,

et al. 2009

J Evidence Based Medicine

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Objective To evaluate the quality of the registration information for trials sponsored by China registered in the WHO primary registries or other registries that meet the requirements of the International Committee of Medical Journal Editors (ICMJE). Methods We assessed the registration information for trials registered in the 9 WHO primary registries and one other registry that met the requirements of ICJME as of 15 October 2008. We analyzed the trial registration data set in each registry and assessed the registration quality against the WHO Trial Registration Data Set (TRDS). We also evaluated the quality of the information in the Source(s) of Monetary or Material Support section, using a specially prepared scale. Results The entries in four registries met the 20 items of the WHO TRDS. These were the Chinese Clinical Trial Registration Center (ChiCR), Australian New Zealand Clinical Trials Registry(NZCTR), Clinical Trials Registry -India (CTRI), and Sri Lanka Clinical Trials Registry (SLCTR). Registration quality varied among the different registries. For example, using the Scale of TRDS, the NZCTR scored a median of 19 points, ChiCTR (median = 18 points), ISRCTN.org (median = 17 points), and Clinical trials.org (median = 12 points). The data on monetary or material support for ChiCTR and ISRCTN.org were relatively complete and the score on our Scale for the Completeness of Funding Registration Quality ranged from ChiCTR (median = 7 points), ISRCTN.org (median = 6 points), NZCTR (median = 3 points) to clinicaltrials.gov (median = 2 points). Conclusion Further improvements are needed in both the quantity and quality of trial registration. This could be achieved by full completion of the 20 items of the WHO TRDS. Future research should assess ways to ensure the quality and scope of research registration and the role of mandatory registration of funded research.

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“…They could follow the International Committee of Medical Journal Editors' recommendation to refuse to consider studies that have been funded by industry contracts that do significantly hamper traditional scientific norms, such as when sponsors assert control over the data or the authors' right to publish (32). Registering clinical trials can also help eliminate bias by ensuring that unfavorable trial results are not ignored or that information about the risks is not distorted (33,34). Also, requirements that authors specify the role of sponsor in the design and conduct of the study; the collection, analyses, and interpretation of the data; and the control of the manuscript are important steps in preserving the integrity of the research enterprise (7).…”

Section: Alternatives To Disclosure Policiesmentioning

confidence: 99%

How do disclosure policies fail? Let us count the ways

Melo‐Martín

Intemann²

2009

FASEB j.

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The disclosure policies of scientific journals now require that investigators provide information about financial interests relevant to their research. The main goals of these policies are to prevent bias from occurring, to help identify bias when it occurs, and to avoid the appearance of bias. We argue here that such policies do little to help achieve these goals, and we suggest more effective alternatives.

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Clinical trial registration: looking back and moving ahead

Cited by 88 publications

References 2 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

Assessment of registration quality of trials sponsored by China

How do disclosure policies fail? Let us count the ways

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