Skip to main content
zenodoopen

SMA-TB Clinical trial: video & electronic informed consent

<p>The first SMA-TB video has been produced aiming a better understanding of SMA-TB Randomized Clinical Trial (RCT) objectives and procedures. This RCT is&nbsp;work package 1 of&nbsp;SMA-TB project. It is&nbsp;entitled <em>&quot;Phase 2b Randomized double-blind, placebo controlled trial to estimate the potential efficacy and safety of two repurposed drugs, acetylsalicylic acid and ibuprofen, for use as adjunct therapy added to, and compared with, the standard WHO recommended TB regimen (SMA-TB)&rdquo;, </em>and is registered in ClinicalTrials.gov data under identifier&nbsp;NCT04575519</p> <p>This video has been conceptualized as an e-informed consent for TB patients aiming their participation in SMA-TB CTs in Georgia and South Africa, as well as for anyone wanting to learn about the SMA-TB CT. The video explains in a very comprehensive way the rationale of SMA-TB concept, how the CT will be performed, what is expected from the patient, which are potential benefits, as well as side effects. The message is produced both in English and in Georgian.</p>

ShareScore

44/100

Overall dataset sharing score

Score breakdown

These five areas show where the dataset supports — or may limit — practical reuse.

Stewardship
8
Harmonization
4
Access
16
Reuse readiness
8
Engagement
8

Topics