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A new trial design to accelerate tuberculosis drug development: the Phase IIC Selection Trial with Extended Post-treatment follow-up (STEP).

Author: AarnoutseRob E, BoereeMartin J, DiaconAndreas H, DooleyKelly E, GillespieStephen H, HeinrichNorbert, HoelscherMichael, KibikiGibson S, NahidPayam, PhillipsPatrick P J, StoutJason E

Research Support, N.I.H., ExtramuralResearch funding provided by the NIH to external research institutions and researchers.
Clinical Trial, Phase IIA Phase II trial is a trial that further evaluates the efficacy and safety of a new drug or treatment, whose safety has been confirmed to some extent in a Phase I trial, in a small number of patients.
Clinical Trial, Phase IIIA Phase III trial is a trial that further rigorously verifies the efficacy and safety of a new drug or treatment, whose efficacy and safety have been confirmed in a Phase II trial, in a large number of patients, and evaluates whether it is superior to existing treatments.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Overview

A novel hybrid phase II/III trial design, the STEP trial, allows for the collection of definitive clinical outcome data in a relatively small number of participants over a shorter period, providing valuable information about the likelihood of success in a future phase III trial.
Paper Details　
Original Abstract of the Article :
BACKGROUND: The standard 6-month four-drug regimen for the treatment of drug-sensitive tuberculosis has remained unchanged for decades and is inadequate to control the epidemic. Shorter, simpler regimens are urgently needed to defeat what is now the world's greatest infectious disease killer. METHO...See full text at original site
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引用元：
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4804526/

データ提供：米国国立医学図書館（NLM）

Accelerating Tuberculosis Drug Development: A New Trial Design

The fight against tuberculosis (TB), a deadly infectious disease, has been going on for decades. Finding new and effective treatments is a top priority in the field of medicine, much like searching for a rare oasis in a vast desert. This research delves into a new trial design called the 'Phase IIC Selection Trial with Extended Post-treatment follow-up (STEP)' that aims to speed up the process of developing new TB drugs. This innovative approach employs a hybrid phase II/III trial, combining elements of early and late-stage testing to streamline the research process. The researchers meticulously analyzed the operational characteristics of this design using both frequentist and Bayesian frameworks, incorporating simulations to evaluate its practical implications. The results were quite promising – the STEP trial demonstrated a high probability of predicting successful drug candidates for future phase III trials, with a smaller number of participants and a shorter timeframe. This is a significant step forward in the quest for new TB treatments.

A More Efficient Approach to TB Drug Discovery

The STEP trial design offers a compelling solution to the challenges of traditional drug development, which often involves lengthy and expensive phase III trials. The STEP trial could potentially identify promising drug candidates with a higher degree of confidence in a shorter amount of time.

Implications for TB Control

These findings could potentially contribute to more effective and timely development of new TB drugs. This could have a profound impact on global public health, especially in regions where TB remains a major health concern. With faster drug development, it's possible to reduce the burden of this deadly disease and improve the lives of millions of people around the world.

Dr. Camel's Conclusion

The STEP trial design is like a camel caravan traversing a desert, utilizing a strategic approach to reach its destination more efficiently. It's a clever way to navigate the complex world of drug development, enabling researchers to make more informed decisions and ultimately bring new and effective treatments to patients faster. This could be a game-changer in the fight against TB, bringing hope to those affected by this devastating disease.

Date :
  1. Date Completed 2016-11-14
  2. Date Revised 2023-11-15
Further Info :

Pubmed ID

27004726

DOI: Digital Object Identifier

PMC4804526

SNS
PICO Info
in preparation
Languages

English

Positive IndicatorAn AI analysis index that serves as a benchmark for how positive the results of the study are. Note that it is a benchmark and requires careful interpretation and consideration of different perspectives.

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