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Related Concept Videos

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
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
Experimental Designs01:16

Experimental Designs

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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...
11.7K
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
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
Testing a Claim about Population Proportion01:24

Testing a Claim about Population Proportion

3.4K
A complete procedure for testing a claim about a population proportion is provided here.
There are two methods of testing a claim about a population proportion: (1) Using the sample proportion from the data where a binomial distribution is approximated to the normal distribution and (2) Using the binomial probabilities calculated from the data.
The first method uses normal distribution as an approximation to the binomial distribution. The requirements are as follows: sample size is large...
3.4K

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Traditional Trail Making Test Modified into Brand-new Assessment Tools: Digital and Walking Trail Making Test
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Traditional Trail Making Test Modified into Brand-new Assessment Tools: Digital and Walking Trail Making Test

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Platform trials.

Matthieu Roustit1, Olivier Demarcq2, Silvy Laporte3

  • 1Inserm CIC1406, university Grenoble Alpes, CHU de Grenoble, 38000 Grenoble, France.

Therapie
|December 18, 2022
PubMed
Summary
This summary is machine-generated.

Platform trials, amplified by COVID-19, streamline drug evaluation by pooling resources. However, their unique nature presents methodological, ethical, and regulatory challenges requiring careful consideration.

Keywords:
Adaptive trialPlatform trialRandomized controlled trial

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Area of Science:

  • Clinical Trials
  • Drug Development
  • Epidemiology

Background:

  • Platform trials have surged in recent years, accelerated by the COVID-19 pandemic.
  • These trials are advantageous for diseases with numerous drug candidates, evolving standards of care, or urgent evaluation needs.
  • Pooling protocols and infrastructure optimizes patient enrollment, costs, and timelines.

Purpose of the Study:

  • To present the methodological, ethical, and regulatory issues inherent in platform trials.
  • To discuss the complexities of sponsorship, data management, and governance in multi-partner platform trials.
  • To explore the acceptability of platform trial findings by regulatory authorities.

Main Methods:

  • Discussion of issues raised during a dedicated round table event.
  • Analysis of the unique characteristics of platform trial designs.
  • Review of ethical, regulatory, and data management considerations.

Main Results:

  • Platform trials offer significant advantages in efficiency and resource optimization.
  • Specific methodological, ethical, and regulatory challenges are associated with platform trials.
  • Complexities in sponsorship, data management, and governance require careful attention.

Conclusions:

  • Platform trials are a valuable tool, especially in dynamic research environments.
  • Addressing the inherent challenges is crucial for successful implementation and regulatory acceptance.
  • Further discussion and guidelines are needed for sponsorship, data management, and governance.