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Related Concept Videos

Clinical Trials01:16

Clinical Trials

11.1K
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...
11.1K
Clinical Trials: Overview01:11

Clinical Trials: Overview

5.4K
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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Preclinical Development: Overview01:28

Preclinical Development: Overview

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Preclinical development consists of a series of tests that ensure the safety and efficacy of a new therapeutic compound before it is tested in humans. There are four main phases to this process. First, safety pharmacology tests are conducted to ensure the drug does not produce any acutely harmful effects. These tests examine parameters such as bronchoconstriction, cardiac dysrhythmias, blood pressure changes, and ataxia. Next, preliminary toxicological testing is performed to determine the...
6.4K
Statistical Software for Data Analysis and Clinical Trials01:12

Statistical Software for Data Analysis and Clinical Trials

1.8K
Statistical software is pivotal in data analysis and clinical trials by providing tools to analyze data, draw conclusions, and make predictions. These software packages range from simple data management applications to complex analytical platforms, supporting various statistical tests, models, and simulation techniques. Their significance lies in their ability to handle vast amounts of data with precision and efficiency, enabling researchers to validate hypotheses, identify trends, and make...
1.8K
Bioavailability Study Design: Healthy Subjects Versus Patients01:15

Bioavailability Study Design: Healthy Subjects Versus Patients

202
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,...
202
Hazard Ratio01:12

Hazard Ratio

688
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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Related Experiment Video

Updated: Mar 21, 2026

Preparation of Peripheral Blood Mononuclear Cell Pellets and Plasma from a Single Blood Draw at Clinical Trial Sites for Biomarker Analysis
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Sharing raw data from clinical trials: what progress since we first asked "Whose data set is it anyway?".

Andrew J Vickers1

  • 1Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, 485 Lexington Avenue, 2nd Floor, New York, NY, 10017, USA. vickersa@mskcc.org.

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Summary

Clinical trial data sharing has shifted from a refusal norm to a recommendation by major organizations. The next challenge is making raw clinical trial data routinely accessible to researchers.

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Area of Science:

  • Clinical Trials
  • Data Science
  • Medical Research

Background:

  • Historically, clinical trial data sharing was uncommon, with researchers often refusing data requests.
  • Early commentaries highlighted the lack of a rational basis for this data withholding.
  • Limited institutional support existed for data sharing a decade ago.

Discussion:

  • Numerous organizations now advocate for or mandate the sharing of raw clinical trial data.
  • The International Committee of Medical Journal Editors proposed data sharing as a publication condition.
  • Extensive literature now addresses various aspects of clinical trial data sharing.

Key Insights:

  • Attitudes towards clinical trial data sharing have undergone a significant transformation.
  • Despite progress, data sharing has not yet become a routine practice.
  • Researchers cannot yet easily access trial data sets as they access published papers.

Outlook:

  • The focus is shifting from changing mindsets to implementing practical data sharing mechanisms.
  • Ensuring routine availability of real clinical trial data sets is the primary goal.
  • The coming years will be critical in establishing data sharing as an unquestioned norm.