Jove
Visualize
Contact Us

Related Concept Videos

Cancer Survival Analysis01:21

Cancer Survival Analysis

340
Cancer survival analysis focuses on quantifying and interpreting the time from a key starting point, such as diagnosis or the initiation of treatment, to a specific endpoint, such as remission or death. This analysis provides critical insights into treatment effectiveness and factors that influence patient outcomes, helping to shape clinical decisions and guide prognostic evaluations. A cornerstone of oncology research, survival analysis tackles the challenges of skewed, non-normally...
340
Clinical Trials: Overview01:11

Clinical Trials: Overview

2.9K
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...
2.9K
Hazard Ratio01:12

Hazard Ratio

110
The hazard ratio (HR) is a widely used measure in clinical trials to compare the risk of events, such as death or disease recurrence, between two groups over time. It reflects the ratio of hazard rates—the instantaneous risk of the event occurring—between a treatment group and a control group. This measure provides valuable insights into the relative effectiveness of a treatment by assessing how the risk of an event differs between the two groups.
For example, in a clinical trial...
110
Comparing the Survival Analysis of Two or More Groups01:20

Comparing the Survival Analysis of Two or More Groups

175
Survival analysis is a cornerstone of medical research, used to evaluate the time until an event of interest occurs, such as death, disease recurrence, or recovery. Unlike standard statistical methods, survival analysis is particularly adept at handling censored data—instances where the event has not occurred for some participants by the end of the study or remains unobserved. To address these unique challenges, specialized techniques like the Kaplan-Meier estimator, log-rank test, and...
175
Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches01:23

Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches

125
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,...
125
Targeted Cancer Therapies02:57

Targeted Cancer Therapies

7.5K
The targeted cancer therapies, also known as “molecular targeted therapies,” take advantage of the molecular and genetic differences between the cancer cells and the normal cells. It needs a thorough understanding of the cancer cells to develop drugs that can target specific molecular aspects that drive the growth, progression, and spread of cancer cells without affecting the growth and survival of other normal cells in the body.
There are several types of targeted therapies against...
7.5K
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
  1. Home
  2. Clinical Benefit, Reimbursement Outcomes, And Prices Of Fda-approved Cancer Drugs Reviewed Through Project Orbis In The Usa, Canada, England, And Scotland: A Retrospective, Comparative Analysis.
  1. Home
  2. Clinical Benefit, Reimbursement Outcomes, And Prices Of Fda-approved Cancer Drugs Reviewed Through Project Orbis In The Usa, Canada, England, And Scotland: A Retrospective, Comparative Analysis.

Related Experiment Video

Preparation of Peripheral Blood Mononuclear Cell Pellets and Plasma from a Single Blood Draw at Clinical Trial Sites for Biomarker Analysis
07:40

Preparation of Peripheral Blood Mononuclear Cell Pellets and Plasma from a Single Blood Draw at Clinical Trial Sites for Biomarker Analysis

Published on: March 20, 2021

16.7K

Clinical benefit, reimbursement outcomes, and prices of FDA-approved cancer drugs reviewed through Project Orbis in

Kristina Jenei1, Arianna Gentilini1, Alyson Haslam2

  • 1Department of Health Policy, London School of Economics and Political Science, London, UK.

The Lancet. Oncology
|July 14, 2024

View abstract on PubMed

Summary
This summary is machine-generated.

More Related Videos

Evaluating the Effectiveness of Cancer Drug Sensitization In Vitro and In Vivo
09:19

Evaluating the Effectiveness of Cancer Drug Sensitization In Vitro and In Vivo

Published on: February 6, 2015

8.7K
Testing Targeted Therapies in Cancer using Structural DNA Alteration Analysis and Patient-Derived Xenografts
10:27

Testing Targeted Therapies in Cancer using Structural DNA Alteration Analysis and Patient-Derived Xenografts

Published on: July 25, 2020

7.2K

Related Experiment Videos

Preparation of Peripheral Blood Mononuclear Cell Pellets and Plasma from a Single Blood Draw at Clinical Trial Sites for Biomarker Analysis
07:40

Preparation of Peripheral Blood Mononuclear Cell Pellets and Plasma from a Single Blood Draw at Clinical Trial Sites for Biomarker Analysis

Published on: March 20, 2021

16.7K
Evaluating the Effectiveness of Cancer Drug Sensitization In Vitro and In Vivo
09:19

Evaluating the Effectiveness of Cancer Drug Sensitization In Vitro and In Vivo

Published on: February 6, 2015

8.7K
Testing Targeted Therapies in Cancer using Structural DNA Alteration Analysis and Patient-Derived Xenografts
10:27

Testing Targeted Therapies in Cancer using Structural DNA Alteration Analysis and Patient-Derived Xenografts

Published on: July 25, 2020

7.2K

Project Orbis aimed to speed cancer drug access but showed no clinical benefit difference. Delays in health technology assessment recommendations and reimbursement raise questions about its effectiveness in faster patient access.

Area of Science:

  • Oncology
  • Regulatory Science
  • Health Economics

Background:

  • Project Orbis is a global initiative to expedite regulatory review of cancer drugs.
  • It involves regulators from the USA, Canada, Australia, UK, Israel, Brazil, Singapore, and Switzerland.
  • The initiative aims to bring promising cancer therapies to patients more quickly.

Purpose of the Study:

  • To evaluate the clinical benefit of cancer drugs reviewed through Project Orbis.
  • To assess the time to regulatory approval and health technology assessment (HTA) recommendations.
  • To analyze reimbursement outcomes and monthly treatment prices for these drugs.

Main Methods:

  • Retrospective comparative analysis of cancer drug approvals from May 2019 to Nov 2023.
  • Compared drugs reviewed by Project Orbis with other FDA-approved cancer drugs.
  • Co-primary outcomes included time to review, HTA recommendation, reimbursement, clinical benefit (PFS and OS gains), and cost.
  • Main Results:

    • 81 of 244 (33%) FDA-approved cancer drugs were reviewed via Project Orbis.
    • No significant difference in overall survival (OS) or progression-free survival (PFS) gains compared to other FDA approvals.
    • High positive recommendation rates by UK (SMC 100%, NICE 40%) and Canadian (CADTH 90%) HTA bodies, but significant delays in HTA recommendations observed.
    • Median monthly treatment cost was $20,000 for Project Orbis drugs.

    Conclusions:

    • Project Orbis did not demonstrate superior clinical outcomes compared to standard FDA approvals.
    • Significant delays or absence of access post-HTA approval question the initiative's ability to accelerate patient access.
    • While regulatory harmonization is beneficial, Project Orbis's current advantages for patient access and cost-effectiveness remain unclear.