© artur stock.adobe.comIn an effort to produce quality data that informs valid clinical trial results and withstands regulatory inspection, trial sites must adhere to many complex and dynamic requirements to be effective. With that in mind, Fatima Laher, director of the Perinatal HIV Research Unit at the University of the Witwatersrand in South Africa, led a research study describing protocol deviations in South Africa’s largest HIV vaccine efficacy trial. This is a rare and honest analysis which reveals the truth behind the scenes—errors occur even in the most rigorous and controlled settings of clinical trials. “Clinical trials occupy the seat for the highest level of evidence, so the idea that clinical trial data are imperfect can feel upsetting,” Laher says. “It would be great if clinical trials start reporting their data quality metrics,” Laher says.

Source: The North Africa Journal July 14, 2023 17:39 UTC