A new study led by Assistant Prof Marco J Haenssgen demonstrated that contextual factors like local health policies influence the results of clinical trials of medical interventions. Involving biomarker test trials in Myanmar, Thailand, and Vietnam, the landmark study calls for the routine collection of social data alongside clinical trials to improve the local appropriateness of medical interventions and help researchers interpret their findings.

Dr Haenssgen and his co-authors from the social sciences (Ern Nutcha Charoenboon, Yuzana Khine Zaw) and tropical medicine (Nga TT Do, Thomas Althaus, Heiman FL Wertheim, Yoel Lubell) analysed nearly one million words of qualitative material from 130 participants, which was collected alongside clinical trials with 4,446 patients. The trials aimed to test the effectiveness of a five-minute finger-prick blood test to reduce antibiotic prescriptions in primary healthcare in response to the threat of drug resistant superbugs that the World Health Organization named one of the “ten threats to global health in 2019.”

Among others, the study found that that, if antibiotics were in over-abundant supply or if healthcare workers were worried about deadly infectious diseases, they were less likely to follow the diagnostic guidance provided by the biomarker test. The study further argues that such clinical trials could also exclude different parts of the relevant target population depending on the context, as some people struggle with accessing healthcare and others might consume antibiotics for conditions that are not currently covered by the biomarker test (e.g. open wounds).

Dr Haenssgen concludes that, “Social-medical research across three low- and middle-income countries does not just require a lot of coordination and patience, but also an open-minded research team. We were fortunate to have all in place, which enabled us to inform the tools and techniques to fight the superbug crisis, and to advance interdisciplinary research methodologies more broadly. This wasn’t easy, but when we consider the emerging challenges to planetary health and sustainable development, interdisciplinary collaboration is the way to go.”

Read more about the study here: https://warwick.ac.uk/newsandevents/pressreleases/antimicrobial_resistance_interventions

And access the full study:

Haenssgen, M. J., Charoenboon, N., Do, N. T. T., Althaus, T., Khine Zaw, Y., Wertheim, H. F. L., et al. (2019). How context can impact clinical trials: a multi-country qualitative case study comparison of diagnostic biomarker test interventions. Trials, 20:111.

Free open access at: https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-019-3215-9

Caption: Pipette heads.

Photo credit: Marco J Haenssgen.