The impact of operational trial approaches on representativeness: Comparison of decentralized clinical trial participants, conventional trial participants, and patients in daily practice.

Decentralized clinical trial (DCT) approaches - in which trial activities are conducted at participants' homes - have the potential to improve representativeness. We present a study that compared the demographics and cardiovascular risk factors of participants from a DCT (ASCEND) and a conventional trial with a similar trial objective (POPADAD) to those of patients in daily practice. We adjudicate that there are relevant differences when comparing the participants of the conventional trial and the DCT, with the latter providing better representativeness in terms of age, insulin use, smoking status, and body mass index, whereas conventional trial participants were more representative in terms of biological sex. Differences in these characteristics were not explained by the eligibility criteria, but are considered attributable to the operational trial approach.
Competing Interests: Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Amos J. de Jong reports financial support was provided by Van Leersum Grant, KNAW Medical Sciences Fund. Mira G.P. Zuidgeest reports financial support and travel were provided by Innovative Health Initiative, SCOPE, DIA, EMA ACT-EU. Helga Gardarsdottir reports financial support was provided by Innovative Health Initiative. CEH is employed by the University of Copenhagen at the Copenhagen Centre for Regulatory Science (CORS). Novo Nordisk A/S and H. Lundbeck A/S have provided CORS with funding for research projects. Neither of the companies was involved in any aspect of the described work. The other authors declared no competing interests for this work. - CEH If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
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