{"id":"94d072ec-ef13-4b46-8a63-a006c3c88c0b","slug":"ethical-and-methodological-considerations-on-conducting-clinical-research-in-poor-and-low-income-countries-viewpoint-of-the-authors-of-the-best-trip-icp-randomized-trial-in-latin-america","title":"Ethical and methodological considerations on conducting clinical research in poor and low-income countries: Viewpoint of the authors of the BEST TRIP ICP randomized trial in Latin America","authors":["Randall M. Chesnut","Nancy Temkin","Sureyya Dikmen","Carlos Rondina","Walter Videtta","Silvia Lujan","Gustavo Petroni","James Pridgeon","Jason Barber","Joan Machamer","Kelley Chaddock","Juanita M. Celix","Marianna Cherner","Terence Hendrix"],"abstract":"Background: The authors of the BEST TRIP trial respond to critiques regarding their study's ethical and methodological considerations. They emphasize that the trial was not solely focused on intracranial pressure (ICP) monitoring but rather on comparing two aggressive treatment protocols for intracranial hypertension. The authors argue that the absence of a placebo group and the unique context of low- and middle-income countries (LMICs) were misrepresented in the critiques. Summary: The authors clarify that the BEST TRIP trial involved two protocols of aggressive treatment for intracranial hypertension, one utilizing monitored ICP and the other based on clinical examination and imaging. They highlight that both treatment groups received aggressive management and that no significant differences were found in clinical outcomes. The letter addresses concerns about equipoise and ethical implications, asserting that the study was ethically approved and relevant to both local and international health needs. Conclusion: The authors advocate for a nuanced understanding of the ethical and practical implications of conducting clinical research in LMICs. They stress the importance of recognizing the validity of local practices and the need for further exploration of ICP monitoring's role in diverse healthcare settings. The authors invite ongoing dialogue about these critical issues in the context of global health research. Keywords: BEST TRIP, intracranial pressure, clinical research, ethical considerations, low-income countries, treatment protocols, equipoise, neurosurgery","thumbnailUrl":null,"publishDate":"2015-07-02T00:00:00.000Z","doi":"10.4103/2152-7806.159841","categories":["Randomized Controlled Trials","Letter to the Editor"],"fullTextUrl":"https://surgicalneurologyint.com/api/articles/94d072ec-ef13-4b46-8a63-a006c3c88c0b/pdf"}