Good Participatory Practice TB drug trial guidelines lay groundwork for research, use of new treatments

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If you consider all the years that time stood still in the world of tuberculosis drug research, the most compelling aspect of the Good Participatory Practice Guidelines for TB Drug Trials just released by a Critical Paths to TB Drug Regimens working group is that occasions exist for them to be used.

With nearly half a century since the last development of a new drug to treat tuberculosis, about 150 tuberculosis treatment trials are either approved or recruiting, according to estimates gleaned from clinical trial databases.

In the interim, while political will and funding to research new approaches to tuberculosis treatment languished, drug-resistant, multi-drug-resistant, extensively drug-resistant and, to all current purposes, untreatable strains of disease flourished, gaining traction in places where poverty and distance from health facilities served as barriers to care.

“We’ve basically turned it from a completely curable disease that was relatively inexpensive to treat, and in a sense, we’ve converted it to a perfectly incurable disease, that is complicated to treat,” says Jim Lavery, associate professor at the University of Toronto, research scientist at St. Michael’s Hospital, and co-chair of the CPTR Stakeholder and Community Engagement working group, which released the guidelines.

“There’s something tragic about tuberculosis, in that we shouldn’t be having to do this at all,” he adds.

Not wanting to watch a repeat of that history was part of the drive behind developing guidelines to include all of those with a stake in the development of new tuberculosis treatments.

The guidelines were inspired by and modeled on the Good Participatory Practice Guidelines for biomedical HIV prevention trials first presented by UNAIDS and Global Advocacy for HIV Prevention (AVAC) in 2007, Lavery said.

They also reflect the same principles– transparency, accountability, respect, in approaches to communities dealing with HIV, a disease that often overlaps with tuberculosis.

Why not, then, just use those guidelines? “A fantastic question,” Lavery says. Even as he answers it, with reflections on the history and challenges of tuberculosis treatment, the reason is more about the future than the past. The idea, it becomes clear, is not just to develop a drug, it but to develop the systems in which that drug will be used.

“If you imagine that world, it will have to include more robust ways to work with communities, to leverage community resources, to leverage collective wisdom and networks, and the way those networks reach into places trials don’t reach into,” he says. “If we don’t have those systems, then we may soon be back to starting from scratch.”

To some extent the guidelines are a work in progress, awaiting refinement as they are put into use, but already, says Lavery, they reflect this meaningful change: “One of the exciting things is to be at least riding the wave, be ahead of it even, instead of trying to catch up.”

The guidelines will be refined and developed as they are put into use, working group project manager Alicia Chou said. The group invites questions, comments, and feedback at info@gpptb.org.

 

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