Searching clinical trials registers: guide for systematic reviewers

Hunter, Kylie E; Webster, Angela C; Page, Matthew J.; Willson, Melina L; McDonald, Steve; Berber, Slavica; Skeers, Peta; Tan, Ava Grace; Parkhill, Anne; Seidler, Anna Lene

doi:10.1136/bmj-2021-068791

Cited by 46 publications

(42 citation statements)

References 44 publications

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“…IPD will enable maximum data availability and quality, allowing consistent analyses across included studies. Furthermore, both published and unpublished evidence will be included, reducing the potential impact of publication bias on our results [28].…”

Section: Discussionmentioning

confidence: 99%

“…We will limit database searches after the year 1980, since no relevant studies are expected before this year. We will also search the trial registries ClinicalTrials.gov and the WHO International Clinical Trials Registry Platform (ICTRP) according to guidance by Hunter et al [28]. The reference lists of other recent systematic reviews will be scrutinized to identify any additional eligible studies.…”

Section: Methods and Analysismentioning

confidence: 99%

“…A systematic search for eligible trials will be undertaken in accordance with the Cochrane Handbook of Systematic Reviews [27] and a guidance paper on searching trial registries [28]. We will Color version available online search standard medical databases for potentially eligible randomized controlled trials, including Medline (OVID), Embase (OVID), Cochrane Central Register of Controlled Trials (CENTRAL), and CINAHL (EBSCO).…”

Section: Information Sources and Search Strategiesmentioning

confidence: 99%

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NETwork Meta-analysis Of Trials of Initial Oxygen in preterm Newborns (NETMOTION): A Protocol for Systematic Review and Individual Participant Data Network Meta-Analysis of Preterm Infants <32 Weeks’ Gestation Randomized to Initial Oxygen Concentration for Resuscitation

et al. 2022

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Background: Internationally recognized guidelines recommend the judicious use of low oxygen (21–30%), titrated to peripheral oxygen saturation targets, for the initiation of resuscitation of very and extremely preterm infants (<32 weeks’ gestation). However, despite more than 10 randomized controlled trials on this question, the ideal initial oxygen concentration for this group of vulnerable infants remains uncertain. Aims: This study aims to assess the effect of various initial oxygen concentrations on (1) all-cause mortality, chronic lung disease, intraventricular hemorrhage, and retinopathy of prematurity; and (2) reaching the prescribed oxygen saturation targets by 5 min after birth, in preterm infants requiring resuscitation. Methods: We will conduct a systematic review and network meta-analysis using individual participant data. Studies of preterm infants <32 weeks’ gestation, randomized to initial oxygen concentration, will be included. We will systematically search medical databases and trial registries for eligible studies (published or unpublished). Records will be screened by two independent reviewers, with conflicts resolved by the inclusion of a third reviewer. Identified initial oxygen concentrations will be grouped into the following nodes: low (≤30%), intermediate (60%), and high (≥90%) oxygen. A two-step random-effects contrast-based network meta-regression will be calculated to compare and rank different oxygen concentrations. Analyses will be intention-to-treat, with the primary outcome of all-cause mortality. Discussion: This is the first individual participant data network meta-analysis of initial oxygen concentrations for the resuscitation of preterm infants. This novel approach may address long-standing uncertainty regarding optimal oxygen supplementation practice for the resuscitation of preterm infants <32 weeks’ gestation.

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Section: Discussionmentioning

confidence: 99%

Section: Methods and Analysismentioning

confidence: 99%

Section: Information Sources and Search Strategiesmentioning

confidence: 99%

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NETwork Meta-analysis Of Trials of Initial Oxygen in preterm Newborns (NETMOTION): A Protocol for Systematic Review and Individual Participant Data Network Meta-Analysis of Preterm Infants <32 Weeks’ Gestation Randomized to Initial Oxygen Concentration for Resuscitation

et al. 2022

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“…In terms of other registries, it is known that CTG is the largest public clinical trial registry [14,15]. In 2021, in a comparative analysis of 18 public registries, 17 of which are recognized by the World Health Organization (WHO) as primary registries and one-CTG-as a 'data provider' [15], we determined that CTG accounted for 58% of the trials in these 18 registries.…”

Section: Discussionmentioning

confidence: 99%

Rare disease patients in India are rarely involved in international orphan drug trials

Chakraborty

Choudhury²,

Chakraborty³

et al. 2022

PLOS Glob Public Health

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We wished to determine whether rare diseases patients from India had been enrolled in international trials to develop novel orphan drugs. There are two reasons to be interested in this. (a) Different ethnic or racial groups may respond differently to a particular drug. India has huge ethnic diversity, and to exclude such participants is to severely limit the diversity of any trial; (b) Even if a suitable drug for a rare disease is available in India, it may be astronomically priced, in a country where most healthcare expenditure is out-of-pocket. We identified 63 orphan drugs, approved by the US Food and Drug Administration (FDA) after 2008, for which there were 202 trials in the US government’s clinical trial registry, ClinicalTrials.gov. Only nine of these trials had run in India. These trials pertained to six drugs. The drugs were for the conditions B-cell Lymphoma, Chronic Myeloid Leukemia, Gaucher disease Type 1, Malaria, Myeloma and Pulmonary Arterial Hypertension. Further research is required as to why patients from India are not part of foreign drug development programmes for rare diseases. We then asked how many of the remaining 193 trials had recruited people of Indian origin, residing in other countries, and found that not more than 1% of these trials had done so. Also, only 11 of the 193 trials had recruited from other lower income countries. Participation from low-income countries in trials for orphan drugs is poor.

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“…A systematic search of the electronic databases MEDLINE, Embase, PsycINFO and Scopus and clinical trials registries ClinicalTrials.gov and the World Health Organization's International Clinical Trials Registry Platform (WHO ICTRP) Search Portal (37) were conducted from inception to March 2022 and May 2022 respectively. The complete search strategies for all databases and clinical trials registries are listed in Supplementary Table 1.…”

Section: Information Sources and Search Strategy [H3]mentioning

confidence: 99%

Eating Disorders In weight-related Therapy (EDIT): Protocol for a systematic review with individual participant data meta-analysis of eating disorder risk in behavioural weight management

Jebeile

Lister

Libesman

et al. 2022

Preprint

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The Eating Disorders In weight-related Therapy (EDIT) Collaboration brings together data from randomised controlled trials of behavioural weight management interventions to identify individual participant risk factors and intervention strategies that contribute to eating disorder risk. We present a protocol for a systematic review and individual participant data (IPD) meta-analysis which aims to identify participants at risk of developing eating disorders, or related symptoms, during or after weight management interventions conducted in adolescents or adults with overweight or obesity. We systematically searched four databases up to March 2022 and clinical trials registries to May 2022 to identify randomised controlled trials of weight management interventions conducted in adolescents or adults with overweight or obesity that measured eating disorder risk at pre- and post-intervention or follow-up. Authors from eligible trials have been invited to share their deidentified IPD. Two IPD meta-analyses will be conducted. The first IPD meta-analysis aims to examine participant level factors associated with a change in eating disorder scores during and following a weight management intervention. To do this we will examine baseline variables that predict change in eating disorder risk within intervention arms. The second IPD meta-analysis aims to assess whether there are participant level factors that predict whether participation in an intervention is more or less likely than no intervention to lead to a change in eating disorder risk. To do this, we will examine if there are differences in predictors of eating disorder risk between intervention and no-treatment control arms. The primary outcome will be a standardised mean difference in global eating disorder score from baseline to immediately post-intervention and at 6- and 12- months follow-up. Identifying participant level risk factors predicting eating disorder risk will inform screening and monitoring protocols to allow early identification and intervention for those at risk.

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Searching clinical trials registers: guide for systematic reviewers

Cited by 46 publications

References 44 publications

Rare disease patients in India are rarely involved in international orphan drug trials

Eating Disorders In weight-related Therapy (EDIT): Protocol for a systematic review with individual participant data meta-analysis of eating disorder risk in behavioural weight management

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