Related Experiment Video
Updated: Dec 6, 2025
04:53
A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition
Published on: September 20, 2019
11.0K
False individual patient data and zombie randomised controlled trials submitted to Anaesthesia
J B Carlisle1,2
1Department of Peri-operative Medicine and Anaesthesia, Torbay Hospital, Torquay, UK.
Anaesthesia
|October 11, 2020
Summary
Review of submitted randomized controlled trials found 14% contained false data, with 8% deemed fatally flawed. Analyzing individual patient data significantly increased detection of these issues, highlighting a critical need for enhanced editorial scrutiny.
Area of Science:
- Medical Research Integrity
- Clinical Trial Data Analysis
- Publication Ethics
Background:
- Concerns exist regarding the prevalence of false data in scientific publications.
- Randomized controlled trials (RCTs) are foundational in medical evidence, making data integrity paramount.
- Previous methods for detecting flawed data may be insufficient.
Purpose of the Study:
- To analyze the baseline summary data of RCTs submitted to Anaesthesia for false data.
- To identify and categorize trials with fatally flawed data ('zombie' trials).
- To assess the impact of individual patient data (IPD) analysis on detecting false and zombie trials.
Main Methods:
- Analysis of 526 RCTs submitted to Anaesthesia between February 2017 and March 2020.
- Categorization of trials with false data as 'zombie' if deemed fatally flawed.
- Comparison of false data and zombie trial detection rates between trials with and without IPD.
Main Results:
- 73 (14%) of submitted trials contained false data; 43 (8%) were categorized as zombie trials.
- IPD analysis detected false data in 44% of cases versus 2% without IPD.
- IPD analysis was independently associated with higher detection of false data (OR 47) and zombie trials (OR 79).
- Significant variations in false data rates were observed across countries of origin.
Conclusions:
- A substantial proportion of submitted RCTs contain false data, with a notable percentage being fatally flawed.
- Individual patient data analysis is a more effective method for identifying data integrity issues in RCTs.
- Journals should consider reviewing individual patient data prior to publication to ensure the reliability of published research.
More Related Videos
06:28E-Patient Counseling Trial E-PACO: Computer Based Education versus Nurse Counseling for Patients to Prepare for Colonoscopy
Published on: August 1, 2019
8.7K
05:39Author Spotlight: A Non-Intubated Video-Assisted Thoracoscopic Surgery with Multimodal Analgesia and Sevoflurane Inhalation Anesthesia
Published on: May 26, 2023
2.0K
Related Concept Videos
01:16Clinical Trials
10.0K
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...
There are four phases in a clinical trial. A phase one...
10.0K
01:11Blinding
3.7K
Blinding is a commonly used method of not telling participants which treatment a subject is receiving. Blinding is a critical part of a randomized control trial or RCT. It reduces the bias that affects the results. In an RCT, blinding is used in the form of a placebo. A placebo effect occurs when untreated subjects falsely believe they have received the treatment and report improved symptoms. A placebo or a dummy treatment is administered to subjects to negate the bias caused by such an effect.
3.7K
01:11Clinical Trials: Overview
4.4K
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...
4.4K
02:07Blind Procedures
12.7K
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...
12.7K
01:23Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches
293
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,...
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...
293
01:13Randomized Experiments
8.6K
The randomization process involves assigning study participants randomly to experimental or control groups based on their probability of being equally assigned. Randomization is meant to eliminate selection bias and balance known and unknown confounding factors so that the control group is similar to the treatment group as much as possible. A computer program and a random number generator can be used to assign participants to groups in a way that minimizes bias.
Simple randomization
Simple...
Simple randomization
Simple...
8.6K