Related Experiment Video
Updated: May 10, 2026
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
Setting up a randomized clinical trial in the UK: approvals and process
Louise Eleanor Greene1, David R Bearn
1Dundee Dental Hospital and School, Dundee, UK. louise.greene@nhs.net
Journal of Orthodontics
|June 25, 2013
Summary
Setting up randomized clinical trials involves complex approvals. This paper simplifies determining necessary healthcare trial approvals and outlines the process for obtaining them efficiently.
Area of Science:
- Healthcare research methodology
- Clinical trial management
Background:
- Randomized clinical trials (RCTs) are the gold standard for evaluating healthcare interventions.
- RCTs are resource-intensive, requiring significant time, funding, and regulatory approvals prior to initiation.
Purpose of the Study:
- To provide a clear guide for identifying essential regulatory approvals for clinical trials.
- To explain the rationale behind each required approval.
- To detail the procedural steps for securing these approvals.
Main Methods:
- Review of regulatory guidelines and common practices in clinical trial initiation.
- Analysis of the typical approval pathways for healthcare intervention studies.
- Compilation of information on the background and acquisition process for key trial approvals.
Main Results:
- Identification of critical regulatory bodies and their specific requirements.
- Explanation of the purpose and scope of each necessary approval.
- A step-by-step procedural overview for obtaining trial authorizations.
Conclusions:
- Understanding and navigating the approval process is crucial for efficient clinical trial setup.
- This guide aims to streamline the initiation phase of healthcare intervention research.
- Proactive planning for regulatory approvals can mitigate delays and resource expenditure.
More Related Videos
07:40Preparation of Peripheral Blood Mononuclear Cell Pellets and Plasma from a Single Blood Draw at Clinical Trial Sites for Biomarker Analysis
Published on: March 20, 2021
07:31Implementation of a Real-Time Psychosis Risk Detection and Alerting System Based on Electronic Health Records using CogStack
Published on: May 15, 2020
Related Concept Videos
01:11Clinical 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...
01:16Clinical 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...
There are four phases in a clinical trial. A phase one...
01:11Blinding
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.
01:28Preclinical Development: Overview
Preclinical development consists of a series of tests that ensure the safety and efficacy of a new therapeutic compound before it is tested in humans. There are four main phases to this process. First, safety pharmacology tests are conducted to ensure the drug does not produce any acutely harmful effects. These tests examine parameters such as bronchoconstriction, cardiac dysrhythmias, blood pressure changes, and ataxia. Next, preliminary toxicological testing is performed to determine the...
01:13Randomized Experiments
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...
01:23Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches
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, controlled...
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast, controlled...