Enlarged care for the community

The second focus of the position paper is the concept of ”enlarged care“. This refers to the general conditions, such as hygienic, and nutritional, in which the participants will live during the trial. It is the duty of the trial’s sponsor to ensure that its participants have access to the best possible care, and their living conditions throughout the trial are such to ensure optimal response to treatment and resistance to study adverse events.

When conducting trials in resource-limited settings it is necessary to look at some aspects and guarantee that they are accounted for before the trial starts. One such aspect is nutrition, and water supply. It goes without saying that if participants do not have access to a sustainable diet they will not react well to a therapy. Also, the participants’ family need to be looked after in terms of treatment and livelihood to avoid sharing of medication, food or other necessities. These factors threat to lessen the benefits of study treatment to the participant but also to compromise the legitimacy of the research and the credibility of its results.