In a decentralized trial (DCT), the patient does not have to come to the research site.
Instead, a study nurse comes to the patient's home and performs everything the protocol requires: drawing blood, recording an ECG, completing questionnaires, and more. In some cases the study physician visits as well. All of this is possible today thanks to smart technologies.
COVID-19 was the turning point. Almost overnight it became clear that trials had to continue even when sites were closed and patients could not come in. Since then, with advances in AI and updates in global regulation, decentralized trials have rapidly become the emerging standard.
Above all, this model makes it possible to reach patients who until now were left outside research, breaking down barriers of distance, mobility and access.
But before getting there, the companies developing the drug or device need to ask themselves a few questions. Are you truly prepared to design a trial in a decentralized model? How will you collect and verify data remotely, including the work of CRAs in the field? And how will you manage so many parties at once from a distance, CROs, sites and patients? Because if reality forces you into this model, it is far better to discover it in advance, not in the middle of the trial.
Decentralized trials are no longer the future. They are the present. The only question is whether you will lead the change, or chase it.