Parents’ decision whether or not to enrol their infant in a clinical trial: towards a patient centred approach? A qualitative study

Background: Clinical trials are the cornerstone of drug evaluation but are difficult to perform in children since obtaining written informed consent from both parents is very challenging. We aimed to identify determinants of parents’ decision whether or not to enrol their child in a clinical trial. Methods A Grounded Theory qualitative approach was used, based on semi-structured interviews with parents who had to give their consent to enrol their child some years before in the TOSCANE study, evaluating the occurrence of chorioretinitis. An interview guide based on bibliographic references, expert consultations and work meetings with the TOSCANE investigators was used during video interviews, conducted until saturation was reached. Interviews were audio-recorded, transcribed anonymously into text format, and double coded before analysis. Results Between April 2020 and April 2021, 18 interviews (nine consenting and nine non-consenting parents) were conducted. Saturation was reached after 16 interviews. The important determinants of parents’ decision, already described in the literature and which could result either in consent or refusal, were: investigator perceived to be human and competent, parents’ personality, parents’ working in healthcare, strong preference for one of the treatment groups, good health of the child, opinions regarding research. New determinants, such as mothers’ guilt about toxoplasmosis transmission, were identified and mostly associated with non-consent. Conclusion Parents' decisions depend on a set of determinants related to family history, personality, and perception of the disease and research, none of them predominating. These determinants suggest that a patient-centred approach could be adopted along with the adequate training of investigators, which requires future assessment.