Jove
Visualize
Contact Us
JoVE
x logofacebook logolinkedin logoyoutube logo
ABOUT JoVE
OverviewLeadershipBlogJoVE Help Center
AUTHORS
Publishing ProcessEditorial BoardScope & PoliciesPeer ReviewFAQSubmit
LIBRARIANS
TestimonialsSubscriptionsAccessResourcesLibrary Advisory BoardFAQ
RESEARCH
JoVE JournalMethods CollectionsJoVE Encyclopedia of ExperimentsArchive
EDUCATION
JoVE CoreJoVE BusinessJoVE Science EducationJoVE Lab ManualFaculty Resource CenterFaculty Site
Terms & Conditions of Use
Privacy Policy
Policies

Related Concept Videos

Bioavailability Study Design: Healthy Subjects Versus Patients01:15

Bioavailability Study Design: Healthy Subjects Versus Patients

199
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,...
199
Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches01:23

Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches

519
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,...
519
Blind Procedures02:07

Blind Procedures

13.8K
Ideally, the people who observe and record the children’s behavior are unaware of who was assigned to the experimental or control group, in order to control for experimenter bias. Experimenter bias refers to the possibility that a researcher’s expectations might skew the results of the study. Remember, conducting an experiment requires a lot of planning, and the people involved in the research project have a vested interest in supporting their hypotheses. If the observers knew which...
13.8K
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

365
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...
365
Ethics in Research01:56

Ethics in Research

26.1K
Today, scientists agree that good research is ethical in nature and is guided by a basic respect for human dignity and safety. However, this has not always been the case. Modern researchers must demonstrate that the research they perform is ethically sound.
26.1K
Bioavailability Study Design: Single Versus Multiple Dose Studies01:11

Bioavailability Study Design: Single Versus Multiple Dose Studies

312
Bioavailability studies are essential for understanding how a drug is absorbed, distributed, metabolized, and excreted in the body. These studies assess the extent and rate at which the active pharmaceutical agent becomes available at the site of action. The design of bioavailability studies can involve single-dose or multiple-dose regimens, each with distinct advantages and limitations.Single-dose studies are the preferred approach due to their simplicity and reduced drug exposure for...
312

You might also read

Related Articles

Articles linked to this work by shared authors, journal, and citation graph.

Sort by
Same author

Histologic and combined histologic-endoscopic outcomes with mirikizumab in Crohn's disease: VIVID-1 trial results.

Journal of Crohn's & colitis·2026
Same author

The Efficacy and Safety of Etrasimod in Mildly to Moderately Active Ulcerative Colitis: Results From the Phase II GLADIATOR Trial.

Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association·2026
Same author

A metabolic constraint in de novo NAD+ synthesis drives mucosal inflammation in IBD.

Journal of Crohn's & colitis·2026
Same author

Hyperbaric oxygen therapy alters bowel perfusion and improves outcomes in patients with treatment-refractory ulcerative colitis: a prospective pilot trial.

Journal of Crohn's & colitis·2026
Same author

Effect of Mirikizumab on Clinical and Endoscopic Outcomes Based on Prior Advanced Therapy Failure in Patients With Moderately to Severely Active Ulcerative Colitis.

United European gastroenterology journal·2026
Same author

Faecalibacterium prausnitzii EXL01 for the Maintenance of Steroid-induced Clinical Response or Remission in Patients with Crohn's Disease: a first in human trial.

Nature communications·2026

Related Experiment Video

Updated: Mar 15, 2026

Author Spotlight: Biological Standardization to Ensure Reproducibility and Harmonization in Research
04:50

Author Spotlight: Biological Standardization to Ensure Reproducibility and Harmonization in Research

Published on: August 4, 2023

1.7K

Standardisation of Study Protocols - Pros and Cons.

Geert D'Haens1

  • 1Academic Medical Centre, Amsterdam, The Netherlands g.dhaens@amc.uva.nl.

Journal of Crohn'S & Colitis
|September 9, 2016
PubMed
Summary

Designing clinical trials for inflammatory bowel diseases (IBD) faces challenges with traditional scoring systems. New validated instruments and central endoscopic review are emerging to improve trial design and patient outcomes.

Keywords:
Crohn’s diseaseclinical trialsinflammatory bowel diseasestandardizationulcerative colitis

More Related Videos

A Protocol of Manual Tests to Measure Sensation and Pain in Humans
07:28

A Protocol of Manual Tests to Measure Sensation and Pain in Humans

Published on: December 19, 2016

21.8K
Problem-Solving Before Instruction PS-I: A Protocol for Assessment and Intervention in Students with Different Abilities
10:26

Problem-Solving Before Instruction PS-I: A Protocol for Assessment and Intervention in Students with Different Abilities

Published on: September 11, 2021

4.5K

Related Experiment Videos

Last Updated: Mar 15, 2026

Author Spotlight: Biological Standardization to Ensure Reproducibility and Harmonization in Research
04:50

Author Spotlight: Biological Standardization to Ensure Reproducibility and Harmonization in Research

Published on: August 4, 2023

1.7K
A Protocol of Manual Tests to Measure Sensation and Pain in Humans
07:28

A Protocol of Manual Tests to Measure Sensation and Pain in Humans

Published on: December 19, 2016

21.8K
Problem-Solving Before Instruction PS-I: A Protocol for Assessment and Intervention in Students with Different Abilities
10:26

Problem-Solving Before Instruction PS-I: A Protocol for Assessment and Intervention in Students with Different Abilities

Published on: September 11, 2021

4.5K

Area of Science:

  • Gastroenterology
  • Clinical Trial Design
  • Inflammatory Bowel Disease (IBD) Research

Background:

  • Traditional composite scores like Crohn's disease activity index (CDAI) and Mayo score lack validation and patient-reported outcomes.
  • Regulatory bodies have criticized existing metrics for poor correlation with objective mucosal disease.
  • Current drug development in IBD often uses distinct induction and maintenance phases, presenting design challenges.

Purpose of the Study:

  • To discuss the challenges in designing clinical trials for inflammatory bowel diseases (IBD).
  • To highlight the limitations of existing disease assessment tools and propose improvements.
  • To explore emerging strategies for optimizing IBD clinical trial design.

Main Methods:

  • Review of current practices in IBD clinical trial design, including induction/maintenance phases.
  • Analysis of criticisms regarding traditional scoring systems (CDAI, Mayo score).
  • Discussion of novel assessment instruments and methodologies, such as central endoscopic review.

Main Results:

  • Traditional IBD trial metrics face scrutiny due to validation and patient outcome concerns.
  • Key challenges include optimal endpoint timing, placebo response reduction, and corticosteroid withdrawal.
  • Re-randomization strategies post-induction require critical evaluation.
  • Emerging validated instruments and central endoscopic review are poised to become standards.

Conclusions:

  • Clinical trial design in IBD requires adaptation beyond traditional scoring systems.
  • Validated patient-reported outcomes and objective measures like endoscopic review are crucial.
  • Future IBD trial designs may be tailored to specific drug mechanisms of action.