Brazilian Clinical Trials Registry and the challenges for clinical research governance

Laguardia, Josué; Piolli, Alessandro Luís; Prevot, Margareth; Ramalho, Luciano; Gamarski, Ricardo; Nishizawa, Claudio

doi:10.1111/j.1756-5391.2011.01145.x

Cited by 4 publications

(3 citation statements)

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“…Therefore, observational studies and clinical trials that do not study a drug, biologic or device are not required to be registered in the database, which may impose biases to the study results. Brazil also has a local platform for registration of clinical trials: the Brazilian Clinical Trials Registry (ReBEC), which was launched in 2010 and is also integrated with the WHO/ICTRP 1 . Some of the studies registered in ReBEC may have not been concomitantly registered in ClinicalTrials.gov, thus our findings might be underestimated.…”

Section: Studies Registered In Clinicaltrialsgov (2010‐2020) Variablmentioning

confidence: 98%

“…This international database contains records of interventional and observational studies, as well as expanded access programs. The conduction of clinical trials in Brazil was first regulated by Resolution 39 from 2008, which established the requirement of clinical trial registration in a World Health Organization's International Clinical Trials Registry Platform (WHO/ICTRP), including ClinicalTrials.gov 1 . The clinical research scenario in Brazil is currently governed by Resolution 09 from 2015, which reinforced the registration requirement 2…”

Section: Studies Registered In Clinicaltrialsgov (2010‐2020) Variablmentioning

confidence: 99%

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Characteristics of Brazilian clinical studies registered in ClinicalTrials.gov between 2010 and 2020

Tiguman

2020

J Evidence Based Medicine

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Aim Evidence‐based medicine uses high‐quality methods, such as randomization and blinding prcedures, to support and inform clinical practice. The investigation of trials registered in clinical research databases may help understand the main characteristics of studies conducted in countries, such as Brazil. This study aimed to investigate the characteristics of Brazilian clinical trials registered in ClinicalTrials.gov in the last decade. Methods Cross‐sectional study performed in ClinicalTrials.gov database with clinical studies registered in Brazil between 2010 and 2020. A search was conducted in the database considering this period using filters for country (Brazil), start date (01 January 2010) and end date (date of the search: 07 May 2020). Descriptive statistics were used to characterize the studies. All analyses were conducted on Stata 14.2. Results In total, 5368 studies were retrieved, which were mostly randomized (93.2%), blinded (63.2%), Phase III (48.7%) interventional studies (89.9%) with small sample sizes (57.2%) conducted with adults (93.0%) using drugs (42.7%) with a treatment purpose (77.3%), with funding from institutions other than the industry, the NIH, and the US Federal (71.3%). Conclusions The majority of Brazilian clinical studies used blinding and randomization procedures in the last 10 years. However, the predominance of trials with small sample sizes and with a focus on adult patients indicate the need of larger studies conducted with the pediatric population.

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Section: Studies Registered In Clinicaltrialsgov (2010‐2020) Variablmentioning

confidence: 98%

Section: Studies Registered In Clinicaltrialsgov (2010‐2020) Variablmentioning

confidence: 99%

Characteristics of Brazilian clinical studies registered in ClinicalTrials.gov between 2010 and 2020

Tiguman

2020

J Evidence Based Medicine

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“…43,599 43,315 284 JRCT (Japan) 53 64,650 60,645 4,005 ANZCTR (Australian New Zealand) 54 24,657 23,374 1,283 ISRCTN.org 55 24,174 22,966 1,208 ReBEC (Brazil) 56 6,735 5,889 846 CRIS (Korea) 57 8,953 8,428 525 DRKS (German) 58 15,693 13,789 1,904 IRCT (Iran) 59 37,782 34,097 3,685 TCTR (Thailand) 60 8,649 7,443 1,206 LTR (Netherland) 61 9,768 9,768 0 PACTR (Africa) 62 4,047…”

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confidence: 99%

Panacea: A foundation model for clinical trial search, summarization, design, and recruitment

Lin,

Xu,

Wang

et al. 2024

Preprint

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Clinical trials are fundamental in developing new drugs, medical devices, and treatments. However, they are often time-consuming and have low success rates. Although there have been initial attempts to create large language models (LLMs) for clinical trial design and patient-trial matching, these models remain task-specific and not adaptable to diverse clinical trial tasks. To address this challenge, we propose a clinical trial foundation model namedPanacea, designed to handle multiple tasks, including trial search, trial summarization, trial design, and patient-trial matching. We also assemble a large-scale dataset, namedTrialAlign, of 793,279 trial documents and 1,113,207 trial-related scientific papers, to infuse clinical knowledge into the model by pre-training. We further curateTrialInstruct, which has 200,866 of instruction data for fine-tuning. These resources enablePanaceato be widely applicable for a range of clinical trial tasks based on user requirements.We evaluatedPanaceaon a new benchmark, namedTrialPanorama, which covers eight clinical trial tasks. Our method performed the best on seven of the eight tasks compared to six cutting-edge generic or medicine-specific LLMs. Specifically,Panaceashowed great potential to collaborate with human experts in crafting the design of eligibility criteria, study arms, and outcome measures, in multi-round conversations. In addition, Panacea achieved 14.42% improvement in patient-trial matching, 41.78% to 52.02% improvement in trial search, and consistently ranked at the top for five aspects of trial summarization. Our approach demonstrates the effectiveness ofPanaceain clinical trials and establishes a comprehensive resource, including training data, model, and benchmark, for developing clinical trial foundation models, paving the path for AI-based clinical trial development.

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Clinical trial approval in world

Peepliwal

2024

Clinical Trial Project Management

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Brazilian Clinical Trials Registry and the challenges for clinical research governance

Cited by 4 publications

References 3 publications

Characteristics of Brazilian clinical studies registered in ClinicalTrials.gov between 2010 and 2020

Characteristics of Brazilian clinical studies registered in ClinicalTrials.gov between 2010 and 2020

Panacea: A foundation model for clinical trial search, summarization, design, and recruitment

Clinical trial approval in world

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