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Related Concept Videos

Clinical Trials01:16

Clinical Trials

11.1K
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...
11.1K
Clinical Trials: Overview01:11

Clinical Trials: Overview

5.3K
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...
5.3K
Blinding01:11

Blinding

4.0K
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.
4.0K
Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches01:23

Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches

519
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,...
519
Preclinical Development: Overview01:28

Preclinical Development: Overview

6.3K
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...
6.3K
Bioavailability Study Design: Healthy Subjects Versus Patients01:15

Bioavailability Study Design: Healthy Subjects Versus Patients

199
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,...
199

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Related Experiment Video

Updated: Mar 14, 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

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Clinical trial involvement.

Marion Evans, Pauline Boyle, Karen Hylton1

  • 1National Institute for Health Research (NIHR) West Midlands.

Nursing Standard (Royal College of Nursing (Great Britain) : 1987)
|September 30, 2016
PubMed
Summary

Clinical trials historically required principal investigators with medical or scientific doctoral degrees. This traditional leadership model is now being re-evaluated for broader inclusivity in research.

Area of Science:

  • Clinical research
  • Medical science
  • Scientific investigation

Background:

  • Historically, principal investigators (PIs) in hospital-based clinical trials were exclusively medical doctors or scientists holding PhDs or postdoctoral qualifications.
  • This established a traditional leadership paradigm in clinical research settings.

Purpose of the Study:

  • To analyze the evolving landscape of leadership in hospital-based clinical trials.
  • To explore the historical qualifications of principal investigators and potential shifts in these requirements.

Main Methods:

  • Review of historical practices in clinical trial leadership.
  • Analysis of academic and professional qualifications of principal investigators over time.

Main Results:

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  • Findings indicate a long-standing requirement for PIs to possess advanced medical or scientific degrees (PhDs, postdoctoral qualifications).
  • The study identifies this as a defining characteristic of past hospital-based clinical trial leadership.

Conclusions:

  • The traditional model for leading clinical trials centered on highly qualified medical or scientific professionals.
  • Understanding this historical context is crucial for evaluating current and future trends in clinical trial leadership and participation.