Related Experiment Video
Updated: Jul 12, 2025
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
Decision making in clinical trials: Interim analyses, innovative design, and biomarkers
Kathleen A Welsh-Bohmer1, Geoffrey A Kerchner2, Shobha Dhadda3
1Department of Psychiatry & Neurology Duke University Durham North Carolina USA.
Abstract:
The efficient and accurate execution of clinical trials testing novel treatments for Alzheimer's disease (AD) is a critical component of the field's collective efforts to develop effective disease-modifying treatments for AD. The lengthy and heterogeneous nature of clinical progression in AD contributes to the challenges inherent in demonstrating a clinically meaningful benefit of any potential new AD therapy. The failure of many large and expensive clinical trials to date has prompted a focus on optimizing all aspects of decision making, to not only expedite the development of new treatments, but also maximize the value of the information that each clinical trial yields, so that all future clinical trials (including those that are negative) will contribute toward advancing the field. To address this important topic the Alzheimer's Association Research Roundtable convened December 1-2, 2020. The goals focused around identifying new directions and actionable steps to enhance clinical trial decision making in planned future studies.
Insights
Optimizing clinical trials for Alzheimer's disease (AD) treatments is crucial. The Alzheimer's Association convened experts to enhance decision-making for more efficient and informative AD drug development.
Area of Science:
- Neuroscience
- Clinical Trials
- Drug Development
Background:
- Alzheimer's disease (AD) clinical trials face challenges due to disease heterogeneity and length.
- Past trial failures highlight the need for optimized decision-making processes.
- Improving trial efficiency maximizes information yield for future research.
Purpose of the Study:
- To identify new directions and actionable steps for enhancing clinical trial decision-making in Alzheimer's disease research.
- To expedite the development of effective disease-modifying treatments for AD.
- To ensure all clinical trials, including negative ones, contribute to advancing the field.
Main Methods:
- Convening of the Alzheimer's Association Research Roundtable on December 1-2, 2020.
- Focused discussion on optimizing all aspects of clinical trial decision making.
- Identification of actionable steps for future Alzheimer's disease studies.
Main Results:
- Key challenges in AD clinical trial execution were identified.
- Strategies for improving decision-making in trial design and management were explored.
- A consensus was reached on the importance of maximizing information from all trials.
Conclusions:
- Enhanced decision-making is vital for efficient and informative Alzheimer's disease clinical trials.
- Optimizing trial processes will accelerate the development of novel AD therapies.
- Future trials must be designed to contribute valuable data, regardless of outcome.
Related Concept Videos
01:16Clinical Trials
There are four phases in a clinical trial. A phase one...
01:11Clinical Trials: Overview
01:23Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...
01:28Preclinical Development: Overview
01:12Analysis of Population Pharmacokinetic Data
01:20Study Designs in Epidemiology
Observational studies are those where the researcher does not intervene but rather observes natural variations. They include cross-sectional, cohort, and...