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Related Concept Videos

Study Design in Statistics01:15

Study Design in Statistics

A study design is a set of techniques that allow a researcher to collect and analyze data from different variables defined for a specific research problem. Statistics is commonly for effective study design and more robust experiments,
Does aspirin reduce the risk of heart attacks? Is one brand of fertilizer more effective at growing roses than another? Is fatigue as dangerous to a driver as the influence of alcohol? Questions like these are answered using randomized experiments with proper...
Experimental Designs01:16

Experimental Designs

An experimental design is a systematic process that allows researchers to evaluate the relationship between dependent and independent variables. There are three widely used types of experimental design - pre-experimental design, true experimental design, and quasi-experimental design. In pre-experimental design, the researcher compares the data before and after some interventions or treatments. The true-experimental design has more than one purposefully created group, a commonly measured...
Crossover Experiments01:16

Crossover Experiments

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.
Bioequivalence Experimental Study Designs: Repeated Measures, Cross-Over, Carry-Over, and Latin Square Designs01:15

Bioequivalence Experimental Study Designs: Repeated Measures, Cross-Over, Carry-Over, and Latin Square Designs

Bioequivalence experimental study designs play a pivotal role in testing the effectiveness of various treatments. Key among these are the repeated measures, cross-over, carry-over, and Latin square designs. In the repeated measures design, each subject receives all treatments, allowing for temporal comparisons. This type of design is useful in reducing variability but requires careful planning to avoid bias.The cross-over design, an economical method, involves sequential administration of...
Behavioral Genetics and Its Designs01:23

Behavioral Genetics and Its Designs

Behavior genetics explores how genetic inheritance influences human behavior. It focuses on how genes, passed from parents to offspring, contribute to the development of behavioral traits and tendencies. This branch of genetics seeks to understand the complex interplay between inherited genetic factors and environmental influences in shaping our behaviors.
The primary methodologies used in behavior genetics include family studies, twin studies, and adoption studies, each providing unique...
Natural Selection and Adaptation01:15

Natural Selection and Adaptation

Natural selection, a fundamental concept in evolutionary biology, is the mechanism by which evolution is driven, favoring organisms that are best adapted to their environments. This process enhances their chances of survival and reproduction. Adaptation, a key outcome of this process, involves genetic modifications that optimize an organism's functionality under specific environmental challenges, such as extreme cold or thinner air at high altitudes.
Beyond physical adaptations, psychological...

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Characterization of Complex Systems Using the Design of Experiments Approach: Transient Protein Expression in Tobacco as a Case Study
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DIA's Adaptive Design Scientific Working Group (ADSWG): Best Practices Case Studies for "Less Well-understood"

Eva Miller1, Paul Gallo2, Weili He3

  • 11 Independent biostatistical consultant, Levittown, PA, USA.

Therapeutic Innovation & Regulatory Science
|September 22, 2018
PubMed
Summary
This summary is machine-generated.

Adaptive designs (ADs) offer flexible clinical trial modifications using accumulating data. Case studies show these less well-understood ADs are valuable for rare diseases and rapid drug development when properly planned.

Keywords:
2010 FDA Adaptive Design guidanceadaptive dose selectionadaptive trialsdata monitoring committeephase IIB/III trial designssample size re-estimation

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Area of Science:

  • Clinical Trials
  • Biostatistics
  • Drug Development

Background:

  • Adaptive design (AD) clinical trials allow modifications based on accumulating data without compromising study integrity.
  • The US FDA identified 7 primary AD types as 'less well-understood' due to limited regulatory experience.

Purpose of the Study:

  • To better understand the properties of less well-understood ADs.
  • To promote the appropriate use of these designs in clinical research.
  • To review case studies and regulatory interactions involving less well-understood ADs.

Main Methods:

  • Conducted an extensive nonsystematic literature search.
  • Reviewed 10 specific case studies where less well-understood ADs were employed.
  • Gathered feedback on challenges, successes, and regulatory interactions.

Main Results:

  • Less well-understood ADs and statistical methods can address challenging research scenarios.
  • These designs are particularly beneficial for rare diseases, small populations, terminal illnesses, and vaccine trials.
  • Successful implementation requires careful planning and precise operational execution.

Conclusions:

  • Less well-understood adaptive designs are essential tools for efficient clinical research.
  • Appropriate utilization of these advanced methodologies is crucial for success.
  • These designs can accelerate the delivery of effective treatments to patients.