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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...
Truncation in Survival Analysis01:09

Truncation in Survival Analysis

Truncation in survival analysis refers to the exclusion of individuals or events from the dataset based on specific criteria related to the time of the event. This exclusion can happen in two primary forms: left truncation and right truncation.
Left truncation occurs when individuals who experienced the event of interest before a certain time are not included in the study. This is often due to a "delayed entry" into the study where only those who survive until a certain entry point are observed.
Censoring Survival Data01:09

Censoring Survival Data

Survival analysis is a statistical method used to analyze time-to-event data, often employed in fields such as medicine, engineering, and social sciences. One of the key challenges in survival analysis is dealing with incomplete data, a phenomenon known as "censoring." Censoring occurs when the event of interest (such as death, relapse, or system failure) has not occurred for some individuals by the end of the study period or is otherwise unobservable, and it might have many different reasons...
Longitudinal Research02:20

Longitudinal Research

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...
Bioavailability Study Design: Healthy Subjects Versus Patients01:15

Bioavailability Study Design: Healthy Subjects Versus Patients

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,...

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Related Experiment Video

Updated: May 24, 2026

A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition
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A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition

Published on: September 20, 2019

Terminating clinical trials without sufficient subjects.

Lianne Damen1, Frans van Agt, Theo de Boo

  • 1Commissie Mensgebonden Onderzoek, Research Ethics Committee, PO Box 9101, Internal Code 578, 6500 HB, Nijmegen, The Netherlands. l.damen@iwkv.umcn.nl

Journal of Medical Ethics
|March 1, 2012
PubMed
Summary

Many medical studies fail to recruit enough participants, leading to termination and exposing subjects to unnecessary risks. Investigator-initiated research faces more recruitment challenges than industry-sponsored studies.

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Area of Science:

  • Medical research ethics
  • Clinical trial management
  • Human subject protection

Background:

  • Medical research involving human subjects requires rigorous oversight by Research Ethics Committees (RECs) to ensure participant safety.
  • Adherence to approved protocols, including adequate subject recruitment, is critical for study validity and ethical conduct.
  • Failure to recruit the necessary number of subjects can compromise research integrity and expose participants to undue risks and burdens.

Purpose of the Study:

  • To evaluate the frequency of medical research studies failing to recruit the required number of subjects.
  • To identify characteristics associated with studies that successfully recruit sufficient subjects versus those that do not.
  • To explore potential solutions for improving subject recruitment in clinical research.

Main Methods:

  • A descriptive study design was employed to analyze subject recruitment in medical research.
  • The study assessed the proportion of research studies terminated due to insufficient subject recruitment.
  • Characteristics differentiating studies with adequate versus inadequate recruitment were identified.

Main Results:

  • A significant proportion of studies (41/107) were terminated because they could not recruit sufficient subjects.
  • Investigator-initiated studies demonstrated a statistically significant higher rate of recruitment problems compared to pharmaceutical company-initiated studies (p=0.028).

Conclusions:

  • Inadequate subject recruitment is a substantial issue in medical research, leading to study terminations and ethical concerns.
  • Investigator-initiated research appears more vulnerable to recruitment challenges than industry-sponsored trials.
  • Strategies to mitigate recruitment failures are necessary to enhance research efficiency and protect human subjects.