PLOS Special Collection launch: Shaping novel TB treatments

March 22, 2019

To commemorate World TB Day, a Special Collection has been released by PLOS Medicine containing a series of articles that articulate the essential new steps in clinical research that will pave the way for the development of tomorrow's optimal treatment for all forms of tuberculosis. This Special Collection is sponsored by the World Health Organization (WHO) and the French National Research Institute for Sustainable Development (IRD-France), and is co-ordinated by Dr Christian Lienhardt, Research Director at IRD-France and Dr Payam Nahid, Professor at University of California, San Francisco, USA.

The series is the outcome of a technical consultation organized by WHO on 11-13th March 2018 on "Advances in Clinical Trial Design for New TB Treatments to identify and outline, through expert consensus, the optimal characteristics of clinical trial designs to inform policy guidance for the development of new TB regimens. Building on the lessons learnt from a rich history of TB clinical trials, experts reviewed the various designs and tools currently used in the conduct of clinical trials and made a series of propositions to advance the field further, with a view to attaining the best quality data possible on new TB treatments. "To accelerate the development of new TB treatments it is essential to maximize sharing data and experiences and improve the way clinical trials are designed says Dr Matteo Zignol, Team Leader, Research for TB Elimination, Global TB Programme, WHO.

An iterative series of clinical trials undertaken in the 1970s and 1980s by the British Medical Research Council and the US Public Health Services established the modern day six-month regimen for drug susceptible TB. Since then, despite the arrival of two newly approved drugs in the market, progress to shortening duration of treatments for TB and improving tolerability of TB regimens has been unacceptably slow, with the treatment of drug-resistant TB still relying on a complex, poorly tolerated, combination of drugs administered for 9 to 20 months duration.

Development of new TB treatments will continue to be hampered by numerous challenges, ranging from the laboratory, with our reliance on mycobacteriology for endpoint definitions, to the field, wherein a clinical trials control arm needs to be selected and implemented in the face of rapidly changing policies. The most commonly touted challenge in TB therapeutics remains the absence of a surrogate marker that can be readily measured and that estimates with adequate certainty the anticipated treatment effect in late stage clinical development. New opportunities are emerging with the recent developments in PK/PD methodologies, novel clinical trial designs, new biomarkers, as well as recent advances in molecular diagnostics. A recently broadened and exciting pipeline of new candidate drugs compels us to revisit our current approaches to TB drug development, and based on the learnings of the last 50 years, to identify and seek consensus on best practices for future TB clinical trial designs. We are at an unprecedented cross point at which reflections on a rich history of clinical trials meet new advances in methodological methods and technologies to move forward research and approaches for new TB treatments, says Dr Christian Lienhardt.

The PLOS Medicine Special Collection launched on the 22nd March 2019 introduces a series of articles that articulate the essential new steps in clinical research that will pave the way for the development of tomorrow's optimal treatment for all forms of TB.
In your coverage please use this URL to provide access to the launched Special Collection:

Image Credit: U.S. Centers for Disease Control and Prevention- Medical Illustrator, Public Health Image Library (PHIL) /

Image Caption: This illustration depicts a three-dimensional (3D) computer-generated image of a cluster of rod-shaped, drug-resistant, Mycobacterium tuberculosis bacteria, the pathogen responsible for causing the disease tuberculosis (TB). The artistic recreation was based upon scanning electron microscopic (SEM) imagery.

Competing Interests: The authors have declared that no competing interests exist.


Related Clinical Trials Articles from Brightsurf:

Nearly 1 in 5 cancer patients less likely to enroll in clinical trials during pandemic
A significant portion of cancer patients may be less likely to enroll in a clinical trial due to the ongoing coronavirus pandemic.

COVID-19 clinical trials lack diversity
Despite disproportionately higher rates of COVID-19 infection, hospitalization and death among people of color, minority groups are significantly underrepresented in COVID-19 clinical trials.

Why we should trust registered clinical trials
In a time when we have to rely on clinical trials for COVID-19 drugs and vaccines, a new study brings good news about the credibility of registered clinical trials.

Inclusion of children in clinical trials of treatments for COVID-19
This Viewpoint discusses the exclusion of children from coronavirus disease 2019 (COVID-19) clinical trials and why that could harm treatment options for children.

Review evaluates how AI could boost the success of clinical trials
In a review publishing July 17, 2019 in the journal Trends in Pharmacological Sciences, researchers examined how artificial intelligence (AI) could affect drug development in the coming decade.

Kidney patients are neglected in clinical trials
The exclusion of patients with kidney diseases from clinical trials remains an unsolved problem that hinders optimal care of these patients.

Clinical trials beginning for possible preeclampsia treatment
For over 20 years, a team of researchers at Lund University has worked on developing a drug against preeclampsia -- a serious disorder which annually affects around 9 million pregnant women worldwide and is one of the main causes of death in both mothers and unborn babies.

Underenrollment in clinical trials: Patients not the problem
The authors of the study published this month in the Journal of Clinical Oncology investigated why many cancer clinical trials fail to enroll enough patients.

When designing clinical trials for huntington's disease, first ask the experts
Progress in understanding the genetic mutation responsible for Huntington's disease (HD) and at least some molecular underpinnings of the disease has resulted in a new era of clinical testing of potential treatments.

New ALS therapy in clinical trials
New research led by Washington University School of Medicine in St.

Read More: Clinical Trials News and Clinical Trials Current Events is a participant in the Amazon Services LLC Associates Program, an affiliate advertising program designed to provide a means for sites to earn advertising fees by advertising and linking to