Standards for clinical trials for treating TB

Abstract

BACKGROUND: The value, speed of completion and robustness of the evidence generated by TB treatment trials could be improved by implementing standards for best practice.METHODS: A global panel of experts participated in a Delphi process, using a 7-point Likert scale to score and revise draft standards until consensus was reached.RESULTS: Eleven standards were defined: Standard 1, high quality data on TB regimens are essential to inform clinical and programmatic management; Standard 2, the research questions addressed by TB trials should be relevant to affected communities, who should be included in all trial stages; Standard 3, trials should make every effort to be as inclusive as possible; Standard 4, the most efficient trial designs should be considered to improve the evidence base as quickly and cost effectively as possible, without compromising quality; Standard 5, trial governance should be in line with accepted good clinical practice; Standard 6, trials should investigate and report strategies that promote optimal engagement in care; Standard 7, where possible, TB trials should include pharmacokinetic and pharmacodynamic components; Standard 8, outcomes should include frequency of disease recurrence and post-treatment sequelae; Standard 9, TB trials should aim to harmonise key outcomes and data structures across studies; Standard 10, TB trials should include biobanking; Standard 11, treatment trials should invest in capacity strengthening of local trial and TB programme staff.CONCLUSION: These standards should improve the efficiency and effectiveness of evidence generation, as well as the translation of research into policy and practice.

New Oxazolidinones for Tuberculosis: Are Novel Treatments on the Horizon?

“…Slow recruitment rates can often delay trial completion, resulting in increased costs [ 101 ]. Studies evaluating M/XDR-TB treatments are often longer than for drug-susceptible TB, resulting in treatment durations ranging from 18 to 24 months and patient follow-ups post-treatment can often vary from 6 months (primary outcome) to 30 months (secondary outcomes), resulting in total trial durations of up to several years [ 102 ]. Phase 2 clinical trials are often conducted to assess drug safety and efficacy, whereas phase 3 trials involve larger and diverse patient populations to evaluate the safety, efficacy and adverse effects.…”