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Related Concept Videos

Clinical Trials01:16

Clinical Trials

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

Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches

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, controlled...
Clinical Trials: Overview01:11

Clinical Trials: Overview

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...
Blinding01:11

Blinding

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.
Preclinical Development: Overview01:28

Preclinical Development: Overview

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...
Dosage Regimens: Designs and Approaches01:28

Dosage Regimens: Designs and Approaches

Designing a dosage regimen, which refers to the manner of drug administration, is a complex process involving the selection of drug dose, route, and frequency. This process is underpinned by pharmacokinetic parameters derived from tests and population averages. These parameters are then tailored to patient-specific variables such as diagnosis, demographics, and allergy status. Once therapy commences, therapeutic response monitoring is critical and achieved through clinical and physical...

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An Affordable HIV-1 Drug Resistance Monitoring Method for Resource Limited Settings
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An Affordable HIV-1 Drug Resistance Monitoring Method for Resource Limited Settings

Published on: March 30, 2014

Sensible approaches for reducing clinical trial costs.

Eric L Eisenstein1, Rory Collins, Beena S Cracknell

  • 1Duke Clinical Research Institute, Duke University Medical Center, Durham, NC, USA. eisen006@mc.duke.edu

Clinical Trials (London, England)
|February 20, 2008
PubMed
Summary

Streamlining large-scale clinical trials can significantly reduce costs without impacting scientific validity. Implementing these changes could free billions for additional biomedical research.

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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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Area of Science:

  • Biomedical Research
  • Clinical Trial Design
  • Health Economics

Background:

  • Biomedical research funding has doubled in the last decade, yet new molecular entity approvals have decreased by 33%.
  • This highlights a potential inefficiency in the drug development pipeline, particularly in large-scale clinical trials.

Purpose of the Study:

  • To evaluate the cost-effectiveness of current large-scale clinical trial practices.
  • To identify opportunities for cost reduction in clinical trials without compromising scientific integrity.

Main Methods:

  • An expert panel proposed modifications to mega-trial designs and operations for improved value.
  • A mega-trial economic model quantified the financial impact of these recommendations, considering factors like study duration, case report form (CRF) length, number of sites, electronic data capture (EDC), and site management.

Main Results:

  • An initial trial design was estimated at $421 million.
  • Implementing electronic data capture (EDC) and modified site management practices led to significant cost reductions.
  • A streamlined design combining five key components achieved a 59% cost reduction, with a more aggressive streamlining resulting in a 90% reduction.

Conclusions:

  • Substantial cost reductions in large-scale clinical trials are feasible while maintaining scientific validity.
  • Proposed modifications could potentially save billions annually, enabling more clinical studies.
  • Further research is recommended to refine these cost-saving strategies for clinical trials.