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Related Concept Videos

Clinical Trials01:16

Clinical Trials

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Clinical trials are prospective experimental studies conducted on humans to determine the safety and efficacy of treatments, drugs, diet methods, and medical devices. Using statistics in clinical trials enables researchers to derive reasonable and accurate conclusions from the collected data, allowing them to make wise decisions in uncertain situations. In medical research, statistical methods are crucial for preventing errors and bias.
There are four phases in a clinical trial. A phase one...
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Clinical Trials: Overview01:11

Clinical Trials: Overview

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Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
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Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches01:23

Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches

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Biopharmaceutical studies constitute a vital field aiming to enhance drug delivery methods and refine therapeutic approaches, drawing upon diverse interdisciplinary knowledge. In research methodologies, the choice between controlled and non-controlled studies significantly influences the study's reliability and accuracy.
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...
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Pharmacovigilance01:19

Pharmacovigilance

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Post-marketing surveillance is a critical component of pharmaceutical regulation, often uncovering unanticipated adverse drug reactions (ADRs) once a drug is widely used over an extended period.
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
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Hazard Ratio01:12

Hazard Ratio

375
The hazard ratio (HR) is a widely used measure in clinical trials to compare the risk of events, such as death or disease recurrence, between two groups over time. It reflects the ratio of hazard rates—the instantaneous risk of the event occurring—between a treatment group and a control group. This measure provides valuable insights into the relative effectiveness of a treatment by assessing how the risk of an event differs between the two groups.
For example, in a clinical trial...
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Bioavailability Study Design: Healthy Subjects Versus Patients01:15

Bioavailability Study Design: Healthy Subjects Versus Patients

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Bioavailability studies are essential for evaluating a drug's therapeutic efficacy and understanding its absorption patterns under various physiological conditions. Conducting such studies on target patient populations provides more relevant data by simulating real-world disease states. However, practical challenges often necessitate the use of young, healthy adult volunteers as study subjects.Patients may exhibit altered drug absorption patterns due to the effects of the disease itself,...
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In Silico Clinical Trials for Cardiovascular Disease
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Toward assessing clinical trial publications for reporting transparency.

Halil Kilicoglu1, Graciela Rosemblat2, Linh Hoang3

  • 1School of Information Sciences, University of Illinois at Urbana-Champaign, Champaign, IL, USA; U.S. National Library of Medicine, National Institutes of Health, Bethesda, MD, USA.

Journal of Biomedical Informatics
|March 1, 2021
PubMed
Summary

This study developed CONSORT-TM, a corpus for annotating randomized controlled trial (RCT) publications. Text mining models, particularly BioBERT, showed promise in identifying methodology items, aiding RCT appraisal and transparency.

Keywords:
CONSORTCorpus annotationReporting guidelinesSentence classificationText mining

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Area of Science:

  • Biomedical Informatics
  • Clinical Trial Methodology
  • Natural Language Processing

Background:

  • Randomized controlled trials (RCTs) are crucial for evidence-based medicine.
  • Ensuring the quality and transparency of RCT reporting is essential for reliable scientific appraisal.
  • The CONSORT (Consolidated Standards of Reporting Trials) statement provides guidelines for reporting RCTs.

Purpose of the Study:

  • To annotate a corpus of RCT publications with CONSORT checklist items.
  • To develop and evaluate text mining methods for automated RCT appraisal using the annotated corpus.
  • To create a publicly available resource (CONSORT-TM) for advancing RCT research.

Main Methods:

  • Annotation of 50 RCT articles at the sentence level using 37 fine-grained CONSORT checklist items.
  • Calculation of inter-annotator agreement using MASI and Krippendorff's α.
  • Experimentation with rule-based and supervised learning (SVM, BioBERT) methods for recognizing methodology items.

Main Results:

  • Creation of CONSORT-TM, a corpus of 10,709 sentences with 5,246 annotated labels.
  • Moderate agreement at article and section levels (MASI: 0.60-0.64), with significant variation among individual items (Krippendorff's α: 0.06-0.96).
  • The BioBERT-based model achieved the best performance for methodology items (micro-F1: 0.71), with combined models showing further improvements.

Conclusions:

  • CONSORT-TM provides a valuable resource for text mining research on RCT transparency and rigor.
  • Low frequency of some CONSORT items poses challenges for model training.
  • The corpus can support peer review and authoring assistance, with potential for improved models using larger datasets and scheme modifications.