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Related Concept Videos

Clinical Trials01:16

Clinical Trials

8.5K
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...
8.5K
Clinical Trials: Overview01:11

Clinical Trials: Overview

4.7K
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...
4.7K
Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches01:23

Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches

631
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,...
631
Bioavailability Study Design: Healthy Subjects Versus Patients01:15

Bioavailability Study Design: Healthy Subjects Versus Patients

252
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,...
252
Bioequivalence studies: Biowaivers01:13

Bioequivalence studies: Biowaivers

433
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...
433
Hazard Ratio01:12

Hazard Ratio

785
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...
785

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Updated: May 5, 2026

A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition
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A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition

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Raw data from clinical trials: within reach?

Peter Doshi1, Steven N Goodman, John P A Ioannidis

  • 1Baltimore, MD 21211, USA.

Trends in Pharmacological Sciences
|December 4, 2013
PubMed
Summary
This summary is machine-generated.

Making clinical trial data widely public should reduce reporting biases and improve research reproducibility. We advocate for broader data availability, arguing against restrictive data-sharing policies.

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Area of Science:

  • Clinical Research
  • Data Science
  • Biomedical Informatics

Background:

  • Selective reporting biases can undermine the integrity of clinical research findings.
  • Reproducibility and trust in clinical research are paramount for scientific advancement and public health.
  • Current debates surround optimal procedures for clinical trial data sharing.

Purpose of the Study:

  • To advocate for widespread public availability of raw data from clinical trials.
  • To address limitations and restrictive caveats within proposed data-sharing policies.
  • To promote enhanced reproducibility and trust in the clinical research ecosystem.

Main Methods:

  • This study presents a critical analysis of existing and proposed clinical trial data-sharing policies.
  • The authors argue for a more open-access approach to clinical research data.
  • The methodology involves evaluating the potential impact of data accessibility on research integrity.

Main Results:

  • Widespread public availability of raw clinical trial data can mitigate selective reporting biases.
  • Enhanced data accessibility is crucial for improving the reproducibility of clinical research.
  • Open data sharing fosters greater trust among researchers, clinicians, and the public.

Conclusions:

  • Policies promoting widespread availability of clinical trial data are essential.
  • Restrictive data-sharing policies may inadvertently limit scientific progress and trust.
  • Advocating for open access to clinical research data strengthens the foundation of evidence-based medicine.