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Related Concept Videos

Clinical Trials01:16

Clinical Trials

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...
Clinical Trials: Overview01:11

Clinical Trials: Overview

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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Tracheostomy Suctioning I: Pre-Procedural Steps

Tracheostomy suctioning is a critical procedure healthcare professionals perform to maintain a patent airway in patients with a tracheostomy tube. This procedure is necessary when secretions accumulate in the airway, causing respiratory distress. Here is a step-wise procedural guide for performing tracheostomy suctioning using an open system.
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Blind Procedures02:07

Blind Procedures

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 child was...

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Related Experiment Video

Updated: May 9, 2026

Involving Individuals with Developmental Language Disorder and Their Parents/Carers in Research Priority Setting
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Involving service users in trials: developing a standard operating procedure.

Bridie Angela Evans1, Emma Bedson, Philip Bell

  • 1College of Medicine, Swansea University, Swansea, Wales, UK. b.a.evans@swansea.ac.uk

Trials
|July 23, 2013
PubMed
Summary
This summary is machine-generated.

This study developed a standard operating procedure (SOP) to guide researchers in involving service users throughout clinical trials. The SOP ensures service user collaboration improves research relevance and quality.

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Area of Science:

  • Health Services Research
  • Clinical Trials Methodology
  • Patient and Public Involvement (PPI)

Background:

  • Funding bodies increasingly mandate service user involvement in research.
  • Existing guidance lacks operational detail for involving service users in trial conduct.
  • A need exists for a formal procedure to integrate service users into research processes.

Purpose of the Study:

  • To develop a Standard Operating Procedure (SOP) for involving service users in clinical trials.
  • To provide practical guidance for researchers on operationalizing service user engagement.
  • To enhance the relevance, accountability, and quality of health research through collaboration.

Main Methods:

  • A collaborative approach involving experienced researchers and service users.
  • Development and refinement of the SOP within a registered clinical trials unit.
  • Iterative drafting and review by all co-authors and stakeholders.

Main Results:

  • Core principles of equality and collaborative processes were defined.
  • A framework for service user involvement across all trial stages was established.
  • Recommendations include minimum representation (2 service users per group), dedicated budget (1% of total research cost), and early engagement.

Conclusions:

  • The SOP offers practical guidance for successful service user involvement in clinical trials.
  • It promotes a culture of continuous service user engagement throughout research.
  • Encourages clinical trials units and funders to support and resource service user involvement.