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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

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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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Bioequivalence studies: Biowaivers01:13

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In certain scenarios, in vitro dissolution tests can replace in vivo bioequivalence studies. This is particularly true when a drug product, though available in varying strengths, maintains proportional similarity in its active and inactive ingredients. In such cases, the need for in vivo bioequivalence studies for lower strength variants may be waived, provided dissolution tests and in vivo studies on the highest strength yield satisfactory results.Bioequivalence can be indicated through...
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The CONSORT Statement: Application within and adaptations for orthodontic trials.

Nikolaos Pandis1, Padhraig S Fleming2, Sally Hopewell3

  • 1Assistant professor, Department of Orthodontics and Dentofacial Orthopedics, Dental School, Medical Faculty, University of Bern, Bern, Switzerland; private practice, Corfu, Greece.

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High-quality randomized controlled trials (RCTs) are crucial for evidence-based medicine. Following the CONSORT statement ensures accurate reporting of RCTs, enhancing their use in healthcare policy and clinical practice.

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Area of Science:

  • Biomedical Research
  • Evidence-Based Medicine
  • Orthodontics

Background:

  • Randomized controlled trials (RCTs) are fundamental to evidence-based medicine and systematic reviews.
  • Accurate and transparent reporting of RCTs is essential for effective use of research findings.
  • The American Journal of Orthodontics and Dentofacial Orthopedics adopted the CONSORT statement in 2004 and has enforced compliance since 2011.

Purpose of the Study:

  • To emphasize the importance of the Consolidated Standards of Reporting Trials (CONSORT) statement in orthodontic research.
  • To guide authors in achieving CONSORT compliance for their submitted RCTs.
  • To highlight the implications of CONSORT guidelines for improving the quality of published orthodontic research.

Main Methods:

  • This article is an explanatory review of the CONSORT reporting guidelines.
  • It focuses on the relevance and implications of individual CONSORT items.
  • The objective is to facilitate author adherence to CONSORT standards.

Main Results:

  • The CONSORT statement is a widely adopted guideline for reporting RCTs in biomedical research.
  • Adherence to CONSORT guidelines improves the transparency and quality of published RCTs.
  • Understanding CONSORT items is key for authors submitting to orthodontic journals.

Conclusions:

  • Implementing CONSORT guidelines is vital for enhancing the quality and impact of orthodontic research.
  • Authors must be aware of and comply with CONSORT standards for accurate RCT reporting.
  • This guidance aims to improve the reliability of evidence used in orthodontic clinical practice and policy.