Jove
Visualize
Contact Us
JoVE
x logofacebook logolinkedin logoyoutube logo
ABOUT JoVE
OverviewLeadershipBlogJoVE Help Center
AUTHORS
Publishing ProcessEditorial BoardScope & PoliciesPeer ReviewFAQSubmit
LIBRARIANS
TestimonialsSubscriptionsAccessResourcesLibrary Advisory BoardFAQ
RESEARCH
JoVE JournalMethods CollectionsJoVE Encyclopedia of ExperimentsArchive
EDUCATION
JoVE CoreJoVE BusinessJoVE Science EducationJoVE Lab ManualFaculty Resource CenterFaculty Site
Terms & Conditions of Use
Privacy Policy
Policies

Related Concept Videos

Clinical Trials: Overview01:11

Clinical Trials: Overview

3.1K
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...
3.1K
Clinical Trials01:16

Clinical Trials

6.9K
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...
6.9K
Preclinical Development: Overview01:28

Preclinical Development: Overview

4.5K
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...
4.5K
Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches01:23

Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches

155
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,...
155
Drug Administration and Therapy Phases: Overview01:26

Drug Administration and Therapy Phases: Overview

608
Drugs, the chemical agents used in diagnosing, treating, or preventing diseases, undergo a four-phase process of development: pharmaceutic, pharmacokinetics, pharmacodynamics, and therapeutic.
The pharmaceutical phase focuses on leveraging the physicochemical properties of the drug to design and manufacture an effective product. Variants include orally administered tablets or capsules, topical creams or ointments, and parenteral-delivery solutions or emulsions.
The pharmacokinetic phase...
608
Crossover Experiments01:16

Crossover Experiments

2.9K
Crossover experiments, also called the repeated-measurements design, is a study design in which all experimental units are exposed to all treatments in different periods. Crossover experiments are generally used in psychology, the pharmaceutical industry, agriculture, and medicine.
Crossover designs are performed even with smaller sample sizes since the samples can act as their controls. These are better than simple randomized trials since patients are exposed to all the treatments.
2.9K

You might also read

Related Articles

Articles linked to this work by shared authors, journal, and citation graph.

Sort by
Same author

Outcomes in Long-Term Follow-Up of Sporadic Parkinson's Disease in the Parkinson's Progression Markers Initiative.

Annals of neurology·2026
Same author

How PPMI Enabled the First Interventional Platform Trial to Test Therapies in Participants With Early-Stage Neuronal Alpha-Synuclein Disease.

Annals of neurology·2026
Same author

Prodromal Lewy Body Disorder Features in REM Sleep Behavior Disorder With Biomarker-Defined Synucleinopathy.

Annals of clinical and translational neurology·2026
Same author

Five-Year Disease Progression in Synuclein Seeding Positive Sporadic Parkinson's Disease.

Annals of clinical and translational neurology·2026
Same author

Ambroxol for Parkinson's Disease.

Movement disorders : official journal of the Movement Disorder Society·2026
Same author

Protocol of ASPro-PD: a phase 3 trial of ambroxol to slow progression in genetically stratified Parkinson's disease.

Journal of neurology·2026
Same journal

Preface.

Handbook of clinical neurology·2026
Same journal

Foreword.

Handbook of clinical neurology·2026
Same journal

Fundus autofluorescence imaging.

Handbook of clinical neurology·2026
Same journal

The electroretinogram as a means to study the physiology of the retina.

Handbook of clinical neurology·2026
Same journal

Adaptive optics scanning light ophthalmoscopy.

Handbook of clinical neurology·2026
Same journal

Modeling the human retina in a dish: Advances and future directions.

Handbook of clinical neurology·2026
See all related articles

Related Experiment Video

Updated: Aug 9, 2025

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

10.7K

Adaptive clinical trials and master protocols.

Andrew McGarry1, Karl Kieburtz2

  • 1Department of Neurology, Cooper University Healthcare at Rowan University, Camden, NJ, United States.

Handbook of Clinical Neurology
|February 21, 2023
PubMed
Summary
This summary is machine-generated.

Adaptive clinical trial designs offer greater flexibility and faster safety and efficacy assessments compared to conventional methods. These innovative approaches optimize trial efficiency and data interpretability for medical interventions.

Keywords:
Adaptive designsClinical trialsContinual reassessment methodMaster protocolsParkinson's diseaseStatistical hypothesesUmbrella trials

More Related Videos

Automated Multiplex Immunofluorescence Panel for Immuno-oncology Studies on Formalin-fixed Carcinoma Tissue Specimens
10:49

Automated Multiplex Immunofluorescence Panel for Immuno-oncology Studies on Formalin-fixed Carcinoma Tissue Specimens

Published on: January 21, 2019

20.7K
Preparation of Peripheral Blood Mononuclear Cell Pellets and Plasma from a Single Blood Draw at Clinical Trial Sites for Biomarker Analysis
07:40

Preparation 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

17.0K

Related Experiment Videos

Last Updated: Aug 9, 2025

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

10.7K
Automated Multiplex Immunofluorescence Panel for Immuno-oncology Studies on Formalin-fixed Carcinoma Tissue Specimens
10:49

Automated Multiplex Immunofluorescence Panel for Immuno-oncology Studies on Formalin-fixed Carcinoma Tissue Specimens

Published on: January 21, 2019

20.7K
Preparation of Peripheral Blood Mononuclear Cell Pellets and Plasma from a Single Blood Draw at Clinical Trial Sites for Biomarker Analysis
07:40

Preparation 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

17.0K

Area of Science:

  • Clinical Trials Methodology
  • Translational Science
  • Drug Development

Background:

  • Randomized, double-blind, placebo-controlled clinical trials are fundamental in medical research.
  • Evolving scientific knowledge necessitates advancements in clinical trial methodologies.
  • Adaptive trial designs represent a significant evolution in clinical trial methodology.

Purpose of the Study:

  • To summarize general designs, advantages, and pitfalls of adaptive clinical trials.
  • To compare adaptive trial designs with conventional clinical trial designs.
  • To review novel seamless designs and master protocols for improving trial efficiency.

Main Methods:

  • Review of adaptive clinical trial designs.
  • Comparison of adaptive and conventional trial designs.
  • Exploration of seamless designs and master protocols.

Main Results:

  • Adaptive designs allow for modifications (e.g., sample size, criteria) based on interim data.
  • These designs can optimize flexibility and expedite safety and efficacy assessments.
  • Seamless designs and master protocols offer potential improvements in trial efficiency and data interpretability.

Conclusions:

  • Adaptive clinical trials enhance the efficiency and flexibility of evaluating medical interventions.
  • Novel approaches like seamless designs and master protocols further optimize clinical trial processes.
  • These advanced methodologies are crucial for accelerating the assessment of new treatments.