Breakthrough for TB Drug Development Tools
Critical for developing new TB drug regimens is the ability to develop and obtain regulatory qualification for prognostic biomarkers and surrogate endpoints. Advancing these drug development tools requires analyzing various clinical trial data sets—a daunting task without a standard way to view the information across studies. The CPTR Data Standards Workgroup (DSI-WG) has tackled this challenge and produced the first consensus TB data standards.
CPTR plans to use the new CDISC TB data standard, along with CDISC SDTM, for analysis of legacy TB clinical trial data and for new studies going forward. CDISC therapeutic area standards are supplements to the CDISC SDTM (Structured Data Tabulation Model) base clinical data standard. These supplements enable CDISC classification of therapeutic area information not represented within SDTMCDISC (Study Data Tabulation Model Clinical Trial Data Interchange Standards Consortium) clinical data standards. They are important tools for collaborative data sharing and enable the aggregation of data from multiple projects which can yield new insights on subtle signals present in the data. Data standards can also shorten the time to inspect and analyze regulatory submissions.
The Workgroup, chaired by Enrique Aviles (C-Path), Eileen Navarro (FDA), and Bron Kisler (CDISC), achieved a major milestone this month by releasing CDISC TB data standard v.1.0 for public review. Comments on the standard’s ‘controlled terminology’ were due by May 25 and comments on the ‘user guide’ are due by June 8. Please put “CDISC TB User Guide” in the subject line of your email.
This milestone is the culmination of an incredible team effort led by Bess LeRoy (C-Path) and Jane Deifenbach (Pharmstat) and included several focus group discussions comprised of members of all of the CPTR Regulatory Science WG participants. The development of an official data standard is critical for the aggregation and evaluation of clinical trial data that will be important for other CPTR work group efforts including liquid culture biomarker qualification and the development of a TB disease progression model.
To learn more about the draft data standard, two recent webinars are now available for viewing at CPTRInitiative.org. The first webinar, conducted on May 17, provides a general overview of the data standards and CDISC process. The second webinar that was held on May 21 provides an in-depth review.
A Message from the CPTR’s Chair of the Advisory Panel:
Hans-Georg Eichler, Senior Medical Officer, European Medicines Agency and Chair of CPTR Advisory Panel, discusses the major regulatory, scientific, and other topics. “Clearly one of the most promising approaches is to develop regimens instead of individual drugs,” he says. “Now, this is where the challenge for the regulators comes in.” To view this video click here.
INNOVATION Q&A: Qualifying A Model For TB Drug Selection
New models are critical to designing and developing the best TB drug regimens. CPTR is playing a central role in obtaining regulatory qualification for the hollow fiber model—a qualified tool that will allow scientists to more quickly develop improved regimens, in part through designing better animal studies that more closely predict research outcomes in humans.. Here, we interview Tawanda Gumbo, MD, Associate Professor of Internal Medicine, UT Southwestern Medical Center in Dallas, Texas, who focuses on integrating pharmacokinetics, pharmacodynamics, and pharmacogenomics and is a leader in the CPTR Preclinical Sciences Workgroup’s Hollow Fiber Qualification Team.
TB Alliance Launches Second Combination Drug Trial
First clinical trial to test a novel drug regimen in both TB and MDR-TB patients
In advance of World TB Day, the TB Alliance announced the launch of NC-002, a new Phase 2 clinical trial testing a drug regimen with the potential to reduce the duration of treatment for TB and some forms of MDR-TB to 4 months—paving the way for shorter, simpler, and better therapies to help stop the pandemic. The new regimen being tested holds particular promise for some MDR-TB patients, as the regimen shows the potential to decrease treatment by 80% and the cost of treatment by 90% compared with today’s current treatment for MDR-TB.
NC-002 tests the new TB drug candidates PA-824 and moxifloxacin in combination with the existing TB drug, pyrazinamide in a new clinical paradigm. Through the use of drug-sensitivity testing, patients that are sensitive to the regimen will be enrolled in the clinical trial, whether they have been previously been classified as “drug-sensitive” or “drug-resistant” patients. The NC-002 trial treats patients for two months and will take place at 8 sites around the world, helping to strengthen clinical capacity.
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CPTR Hosts World TB Day Briefing featuring US Gov’t Representatives
On March 19 in Washington DC, CPTR hosted Cure All: A briefing on the most promising TB drug research. Hosted at the Kaiser Family Foundation, the event featured a panel of senior representatives from a number of US government organizations, as well an announcement of a new regimen trial by the TB Alliance.
“There really is reason for optimism with TB because of the state of the TB research,” said Dr. Anthony Fauci, Director of the National Institute of Allergy and Infectious Diseases (NIAID), in his keynote address. Other event speakers included Christine Lubinski (IDSA), Dr. Janet Woodcock, (US FDA), Robert Clay (USAID), and Dr. Mel Spigelman (TB Alliance).
Topics addressed included current research initiatives underway in TB pathogenesis, including development of drugs, vaccines, and diagnostics, and the supporting resources and systems required for approval and introduction of new TB technologies. One recurring theme throughout the talks was the need for cross-sector collaboration, as the TB epidemic is multifaceted and requires interventions of various types of stakeholders.
Click here for an event summary
Third Community Engagement Forum Will Leverage Knowledge, Inform Best Practices
The TB Alliance is hosting its third Community Engagement Forum from June 18-21, 2012 in Cape Town, South Africa. This forum is targeted to individuals who have a direct role in leading, managing, and implementing site-level community engagement (CE) programs and activities around tuberculosis (TB) drug clinical trials. These individuals include Community Liaison Officers (CLOs), Community Advisory Board (CAB) members, and other research staff that have a role in the implementation of CE activities at their site. This forum promotes cross-site engagement, sharing, and learning. It also provides opportunities for skills and capacity building.
This year’s forum will highlight the importance, benefits, and challenges of implementing CE in TB drug research and, through the sharing of individual site-level experience, will help to identify best practices as well as common barriers to CE program implementation in TB clinical trials.
Other aspects of the forum will focus on:
The forum will provide both an educational opportunity and hands-on practice, with the goal of exposing forum participants to skills and tools that they can utilize at their sites.
At the conclusion of the forum, participants are expected to be able to:
The CPTR Stakeholder and Community Engagement Workgroup is coordinating with this forum as an opportunity to engage with some of the CE practitioners involved in CPTR clinical trial sites. The group’s goal is to pull together the experiences and strategies of the forum participants to work towards solutions to common challenges with the aim of establishing some best practices for CE in TB clinical trials.