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Related Concept Videos

Clinical Trials: Overview01:11

Clinical Trials: Overview

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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...
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Clinical Trials01:16

Clinical Trials

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

Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches

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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.
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Study Designs in Epidemiology01:20

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Epidemiological study designs are fundamental tools for investigating the distribution, determinants, and control of health conditions in populations. They help researchers understand the relationships between exposures and outcomes, and they broadly fall into two categories: "observational" and "experimental" studies.
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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

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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...
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Bioavailability Study Design: Healthy Subjects Versus Patients01:15

Bioavailability Study Design: Healthy Subjects Versus Patients

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Bioavailability studies are essential for evaluating a drug's therapeutic efficacy and understanding its absorption patterns under various physiological conditions. Conducting such studies on target patient populations provides more relevant data by simulating real-world disease states. However, practical challenges often necessitate the use of young, healthy adult volunteers as study subjects.Patients may exhibit altered drug absorption patterns due to the effects of the disease itself,...
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Related Experiment Video

Updated: Mar 21, 2026

A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition
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Clinical Trial Design Issues in Systemic Sclerosis: an Update.

Jessica K Gordon1, Robyn T Domsic2

  • 1Hospital for Special Surgery, 535 East 70th Street, New York, NY, 10021, USA. gordonj@hss.edu.

Current Rheumatology Reports
|May 6, 2016
PubMed
Summary

Designing clinical trials for systemic sclerosis (scleroderma, SSc) is challenging due to a lack of outcome measures and disease heterogeneity. Improving trial design is crucial for developing new therapies for this rare, fatal condition.

Keywords:
Clinical trial designSclerodermaSystemic sclerosis

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Area of Science:

  • Rheumatology
  • Clinical Trial Design
  • Translational Medicine

Background:

  • Systemic sclerosis (SSc), or scleroderma, is a severe multisystem autoimmune disease with high mortality and no FDA-approved therapies.
  • Current understanding of SSc pathogenesis is advancing, prompting the development of targeted therapies for clinical trials.
  • SSc presents significant challenges for clinical trial design, hindering therapeutic development.

Purpose of the Study:

  • To review and highlight the key challenges in designing clinical trials for systemic sclerosis.
  • To identify areas for improvement in SSc clinical trial methodology.

Main Methods:

  • This review focuses on analyzing current issues in systemic sclerosis clinical trial design.
  • Discussion includes challenges related to outcome measures, disease heterogeneity, and patient recruitment.

Main Results:

  • Validated clinical outcome measures are lacking for many SSc manifestations, complicating disease activity assessment.
  • The heterogeneity of SSc and difficulty in predicting disease progression pose significant hurdles for trial stratification.
  • Biomarker development is nascent, and patient recruitment is challenging due to the rarity of SSc.

Conclusions:

  • Systemic sclerosis clinical trials face substantial design challenges, including the need for validated outcome measures and better predictive models for disease progression.
  • Addressing these issues is essential for advancing the development of effective targeted therapies for SSc.
  • Improved clinical trial design is critical to overcome the obstacles in bringing new treatments to patients with this rare and deadly disease.