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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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Data Collection by Experiments01:13

Data Collection by Experiments

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Data collection is a systematic method of obtaining, observing, measuring, and analyzing accurate information. An experimental study is a standard method of data collection that involves the manipulation of the samples by applying some form of treatment prior to data collection. It refers to manipulating one variable to determine its changes on another variable. The sample subjected to treatment is known as “experimental units.”
An example of the experimental method is a public...
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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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Data Collection I01:30

Data Collection I

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Data collection gathers information needed to make accurate judgments about a patient's present condition. During a health history interview, subjective data is collected from the patient, their caregivers, or family members, and objective data is collected through observations and physical assessment. Patients are the primary source of subjective data. Thus information gathered from patients through interviews, observations, and physical examination is primary data. Secondary sources of...
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Data Collection II01:29

Data Collection II

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The nursing history captures and records the patient's health status, so that a care plan evolves to meet the patient's individual needs. The nursing health history is a part of the initial assessment. A comprehensive history covers all health dimensions and plays a significant role in the assessment process. A comprehensive history includes the patient's biographical information, reasons for seeking health care, expectations, present and past health history, medications, and...
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Biobank for Translational Medicine: Standard Operating Procedures for Optimal Sample Management
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Insights Informing Strategies for Optimizing the Collection of Clinical Trial Data.

Kenneth Getz1, Emily Botto2, Ana Calduch Arques3

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

Therapeutic Innovation & Regulatory Science
|December 30, 2025
PubMed
Summary

Clinical trial data collection is increasing, with non-core and non-essential procedures contributing significantly to participant and site burden. Optimizing protocols by reducing unnecessary data collection can lower burden.

Keywords:
Clinical protocolClinical research dataClinical trial designProtocol complexityProtocol dataProtocol designProtocol endpoints

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Area of Science:

  • Clinical research operations
  • Data management in clinical trials
  • Pharmaceutical development

Background:

  • Past research quantified procedures supporting clinical trial endpoints but not data volume or participant burden.
  • Growing data collection impacts clinical trial efficiency and resource allocation.

Purpose of the Study:

  • To update benchmarks for data collection in clinical trials.
  • To identify opportunities for optimizing data collection and reducing participant and site burden.

Main Methods:

  • Analysis of 105 multi-therapeutic clinical trial protocols initiated after 2018.
  • Categorization of procedures into core, standard, and non-core based on endpoint support.
  • Assessment of data volume, procedure necessity, and associated burden.

Main Results:

  • Average data volume per Phase III protocol is 5.9 million datapoints, growing 11% annually.
  • Non-core procedures account for 16-18% of total procedures, with much data collected for exploratory purposes.
  • Non-essential procedures supporting core endpoints contribute 8.2-17.1% of total datapoints and up to 30% of participant/site burden.

Conclusions:

  • A significant portion of clinical trial procedures and data collection is non-core or non-essential.
  • Reducing non-core and non-essential data collection, particularly from questionnaires, can substantially decrease participant and site burden.
  • Simplifying protocol design is crucial for improving clinical trial efficiency and participant experience.