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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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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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Ethics in Research01:56

Ethics in Research

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Today, scientists agree that good research is ethical in nature and is guided by a basic respect for human dignity and safety. However, this has not always been the case. Modern researchers must demonstrate that the research they perform is ethically sound.
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Hazard Ratio01:12

Hazard Ratio

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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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Methods of Documentation V: CBE01:23

Methods of Documentation V: CBE

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Charting by Exception, or CBE, is a method of documentation used in healthcare, particularly in nursing, that focuses on documenting only significant or abnormal findings rather than recording every detail. This approach aims to streamline the documentation process, improve efficiency, and ensure that healthcare providers can quickly identify deviations from normalcy in patient assessments.
In CBE, healthcare professionals establish predefined standards of practice that define what constitutes...
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Blind Procedures02:07

Blind Procedures

10.6K
Ideally, the people who observe and record the children’s behavior are unaware of who was assigned to the experimental or control group, in order to control for experimenter bias. Experimenter bias refers to the possibility that a researcher’s expectations might skew the results of the study. Remember, conducting an experiment requires a lot of planning, and the people involved in the research project have a vested interest in supporting their hypotheses. If the observers knew which...
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Related Experiment Video

Updated: Jul 1, 2025

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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New Benchmarks on Protocol Amendment Practices, Trends and their Impact on Clinical Trial Performance.

Kenneth Getz1, Zachary Smith2, Emily Botto2

  • 1Tufts Center for the Study of Drug Development, Tufts University School of Medicine, Boston, USA. kenneth.getz@tufts.edu.

Therapeutic Innovation & Regulatory Science
|March 4, 2024
PubMed
Summary

Clinical trial amendments are increasing, with more than 76% of protocols now requiring changes. These amendments, often unavoidable, significantly impact trial timelines and performance, especially during pandemics.

Keywords:
Clinical trial executionProtocol amendmentsProtocol complexityProtocol designProtocol optimization

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Area of Science:

  • Clinical trial management
  • Pharmaceutical research
  • Regulatory affairs

Background:

  • Protocol amendments are common in clinical trials.
  • The COVID-19 pandemic has potentially impacted amendment trends.

Purpose of the Study:

  • To assess trends in clinical trial protocol amendment experiences.
  • To evaluate the impact of amendments on clinical trial performance.
  • To analyze amendment trends during the COVID-19 pandemic.

Main Methods:

  • Follow-up study conducted by Tufts CSDD in 2022.
  • Data collected from 16 pharmaceutical companies and CROs.
  • Analysis of 950 protocols and 2188 amendments across phases I-IV.

Main Results:

  • Prevalence of amended protocols increased from 57% to 76% since 2015.
  • Mean amendments per protocol rose to 3.3 (from 2.1), a 60% increase.
  • Amendment implementation time nearly tripled; average duration is 260 days.
  • 77% of amendments were unavoidable, driven by regulatory and strategic changes.
  • Amended protocols showed increased patient screening and reduced enrollment deviations.
  • Protocols during the pandemic had significantly more amendments.

Conclusions:

  • Clinical trial amendments are becoming more frequent and complex.
  • Amendments significantly affect trial duration and operational efficiency.
  • Regulatory and strategic changes are primary drivers for amendments.
  • Pandemic conditions exacerbated amendment trends and their impact.