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

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

Bioavailability Study Design: Healthy Subjects Versus Patients

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,...
Kaplan-Meier Approach01:24

Kaplan-Meier Approach

The Kaplan-Meier estimator is a non-parametric method used to estimate the survival function from time-to-event data. In medical research, it is frequently employed to measure the proportion of patients surviving for a certain period after treatment. This estimator is fundamental in analyzing time-to-event data, making it indispensable in clinical trials, epidemiological studies, and reliability engineering. By estimating survival probabilities, researchers can evaluate treatment effectiveness,...

You might also read

Related Articles

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

Sort by
Same author

Women's health initiative strong and healthy silent atrial fibrillation recording study: Rationale, study design, and baseline data.

American heart journal·2026
Same author

Survival After the First Myocardial Infarction in Older Women: A Prospective Cohort Analysis From the WHI.

Journal of the American Heart Association·2026
Same author

Systemic immune dysregulation in hypertensive disorders of pregnancy persists years after delivery.

Frontiers in immunology·2026
Same author

Reply: Targeted Therapy for Hypertension in Pregnancy: Hemodynamics as a Therapeutic Compass.

JACC. Advances·2026
Same author

Systemic immune dysregulation in hypertensive disorders of pregnancy persists years after delivery.

bioRxiv : the preprint server for biology·2025
Same author

Economic Outcomes and Quality of Life After CABG or PCI for Multivessel Disease: The FAME 3 Trial.

Journal of the American College of Cardiology·2025

Related Experiment Video

Updated: Jul 10, 2026

A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition
04:53

A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition

Published on: September 20, 2019

Economic evaluation in long-term clinical trials.

Mark A Hlatky1, Derek B Boothroyd, Iain M Johnstone

  • 1Department of Health Research and Policy, Stanford University School of Medicine, Stanford, CA 94305-5405, USA. hlatky@stanford.edu

Statistics in Medicine
|September 27, 2002
PubMed
Summary

Collecting and analyzing medical cost data in long-term clinical trials presents challenges. This study explores methods for cost-effectiveness analysis, crucial for understanding therapy value over time.

More Related Videos

E-Patient Counseling Trial (E-PACO): Computer Based Education versus Nurse Counseling for Patients to Prepare for Colonoscopy
06:28

E-Patient Counseling Trial (E-PACO): Computer Based Education versus Nurse Counseling for Patients to Prepare for Colonoscopy

Published on: August 1, 2019

A Video Protocol of a Randomized Controlled Clinical Trial - Electrochemotherapy of Cutaneous Metastases with Reduced Dose Bleomycin (BLESS Trial)
04:11

A Video Protocol of a Randomized Controlled Clinical Trial - Electrochemotherapy of Cutaneous Metastases with Reduced Dose Bleomycin (BLESS Trial)

Published on: June 9, 2026

Related Experiment Videos

Last Updated: Jul 10, 2026

A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition
04:53

A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition

Published on: September 20, 2019

E-Patient Counseling Trial (E-PACO): Computer Based Education versus Nurse Counseling for Patients to Prepare for Colonoscopy
06:28

E-Patient Counseling Trial (E-PACO): Computer Based Education versus Nurse Counseling for Patients to Prepare for Colonoscopy

Published on: August 1, 2019

A Video Protocol of a Randomized Controlled Clinical Trial - Electrochemotherapy of Cutaneous Metastases with Reduced Dose Bleomycin (BLESS Trial)
04:11

A Video Protocol of a Randomized Controlled Clinical Trial - Electrochemotherapy of Cutaneous Metastases with Reduced Dose Bleomycin (BLESS Trial)

Published on: June 9, 2026

Area of Science:

  • Health Economics
  • Clinical Trial Methodology
  • Biostatistics

Background:

  • Economic endpoints are increasingly vital in long-term clinical trials.
  • Methodological challenges exist in collecting, analyzing, and interpreting medical cost data.
  • Accurate cost assessment is essential for evaluating healthcare interventions.

Purpose of the Study:

  • To outline methods for collecting and analyzing medical cost data in long-term clinical trials.
  • To describe cost-effectiveness analysis (CEA) and its application in randomized trials.
  • To highlight the importance of long-term cost and survival projections.

Main Methods:

  • Discusses methods for measuring cost of care: billed charges, micro-costing, and resource utilization with cost weights.
  • Recommends adjusting monetary units for inflation and discounting in long-term studies.
  • Suggests modified Kaplan-Meier curves for temporal cost patterns and log-transformed regression for skewed cost data.

Main Results:

  • Cost-effectiveness ratios can change significantly with longer follow-up, especially for initially expensive therapies.
  • Longer follow-up periods are critical for accurately assessing the value of new therapies.
  • Modeling long-term cost and survival patterns beyond trial duration provides essential perspective.

Conclusions:

  • Standardized methods for economic endpoint analysis are needed in long-term clinical trials.
  • Cost-effectiveness analysis requires careful consideration of data collection, analysis, and interpretation.
  • Projecting long-term outcomes is crucial for a comprehensive understanding of therapeutic value.