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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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Longitudinal Research02:20

Longitudinal Research

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Sometimes we want to see how people change over time, as in studies of human development and lifespan. When we test the same group of individuals repeatedly over an extended period of time, we are conducting longitudinal research. Longitudinal research is a research design in which data-gathering is administered repeatedly over an extended period of time. For example, we may survey a group of individuals about their dietary habits at age 20, retest them a decade later at age 30, and then again...
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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.
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Regression Toward the Mean01:52

Regression Toward the Mean

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Regression toward the mean (“RTM”) is a phenomenon in which extremely high or low values—for example, and individual’s blood pressure at a particular moment—appear closer to a group’s average upon remeasuring. Although this statistical peculiarity is the result of random error and chance, it has been problematic across various medical, scientific, financial and psychological applications. In particular, RTM, if not taken into account, can interfere when...
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Survival Curves01:18

Survival Curves

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Survival curves are graphical representations that depict the survival experience of a population over time, offering an intuitive way to track the proportion of individuals who remain event-free at each time point. These curves are widely used in fields such as medicine, public health, and reliability engineering to visualize and compare survival probabilities across different groups or conditions.
The Kaplan-Meier estimator is the most common method for constructing survival curves. This...
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What can we learn from trial decliners about improving recruitment? Qualitative study.

Adwoa Hughes-Morley1,2, Bridget Young3, Roelie J Hempel4

  • 1MRC North West Hub for Trials Methodology Research, Manchester Academic Health Science Centre, University of Manchester, Oxford Road, Manchester, M13 9PT, UK. adwoa.hughes-morley@york.ac.uk.

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Understanding why people decline clinical trials is key to improving recruitment. Most participants declined due to perceived ineligibility or lack of need for the trial therapy, not trial burden.

Keywords:
DepressionNon-participationQualitative researchRandomised controlled trialsRecruitment

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Area of Science:

  • Clinical Psychology
  • Medical Research Methodology

Background:

  • Clinical trial recruitment faces significant challenges globally.
  • Understanding reasons for participant non-recruitment is crucial for developing effective solutions.

Purpose of the Study:

  • To investigate the decision-making process of individuals who declined participation in a psychological therapy trial for depression.
  • To identify factors influencing trial non-recruitment to inform strategies for improving participant engagement.

Main Methods:

  • Qualitative study involving semi-structured interviews with individuals who declined the REFRAMED trial.
  • Grounded theory approach used for the analysis of interview transcripts.

Main Results:

  • Twenty individuals were interviewed, revealing a four-stage decision process for declining trial participation.
  • Primary reasons for declining included self-assessed ineligibility and perceived lack of need for the trial therapy.
  • A subset of 'prior decliners' consistently opt out of trials, distinct from those declining based on specific trial assessments.

Conclusions:

  • Improving trial recruitment necessitates addressing patient perceptions of eligibility and treatment benefit.
  • Interventions should focus on clarifying trial relevance and suitability rather than solely on reducing participation burden.