An international TB Partnership looking for Trial Sites for upcoming phase I and II trials.

The CPTR Initiative aims to accelerate the development of new, safe, and highly effective tuberculosis (TB) treatment regimens with shorter therapy durations. The group is a broad collaboration of pharmaceutical companies; government, regulatory, and multilateral agencies; academia; civil society; advocates; and non-government organizations, and the website can be found at: http://www.c-path.org/CPTR.cfm.

Although TB is often thought of as a disease of the past, 1.7 million people die from it each year. The drugs are over 40 years old, have significant adverse effects and drug interactions, the treatment regimens are unacceptably long, resistance to current drugs is increasing, and the standard sequential regimen development process would be unacceptably long. The mission of CPTR is therefore to address an urgent global public health need, with the goal of saving millions of lives.

The three main goals of the C-Path TB Drug Regimens Science Consortium are:

• Establishing consensus among scientists from industry, academia, regulatory authorities and other entities regarding preferred tools for developing new TB drugs and drug regimens;

• Creating innovative drug development tools; e.g., TB data standards, biomarkers and clinical endpoints, preclinical and clinical science tools, and clinical disease progression models; and

• Obtaining qualification of such drug development tools for specific context of use from regulatory authorities.

To achieve this, there are five working groups and an additional Integrated Science Team to coordinate the activities of these work groups. The workgroups include the following:

• Data Standards and Integration

• Biomarkers and Clinical Endpoints

• Preclinical and Clinical Sciences

• Clinical Disease and Progression modelling

• Health Authority Submission

Working together, the groups aim to develop TB treatment by improving safety through predictive safety testing; by improving efficacy through the use of Patient Reported Outcome data; and through sharing disease knowledge through the Coalition Against Major Diseases.

To this end, the partnership is interested in TB drug Phase I/II trials in high burden countries for TB especially Uganda, South Korea, South Africa, Peru, India, China. The partnership invites potential researchers to get into with them through the Global Health Trials messaging system (click on the highlighted name on the authorship of this article) or at (is there a contact email address on the website?). We seek the following information from research sites;

1. Details of any previous experience of TB clinical research

2. Details of any previous clinical trial experience

3. Brief indication of local TB burden

4. Local clinical trial regulatory requirements

5. Contact info for the Ethics Committee(s) and any national clinical trial approval committees (if possible) and meeting frequency (if known)

6. Details of study drug import requirements (if known)

We also welcome any feedback and comments and encourage groups to get in touch even if they cannot provide answers to all the questions above.

We have a comprehensive set of future clinical trials being planned and seek to encourage research sites to register their interest with us.

Please get in touch if you might be able to collaborate with us as a trial site for some of these trials. Write via an email to info@globalhealthtrials.org

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