Decentralised clinical trials (DCT) are clinical trials in which patients take part from home for most or all of the trial, instead of travelling to a hospital for every visit. A DCT platform is the software that makes this possible. It provides online consent, video visits with the trial doctor, readings from devices worn at home and delivery of the medicine to the patient's door.
Why do this? Many people who could join a trial live far from the few hospitals that run trials. Travelling every two weeks costs them a day's wages and the fare. So many patients refuse, or drop out halfway. A trial that comes to the patient can recruit faster and keep more patients until the end.
Here is a typical case. A farmer who lives two hours from Coimbatore joins a trial of a new diabetes medicine. He first signs up on the trial's app. The app checks his identity with an identity verification service. A trial doctor explains the trial on a video call, and he signs the consent form with an electronic signature. In India, consent for some patients must also be recorded on audio and video, and the platform stores that recording. The medicine is couriered to his home. He wears a glucose sensor on his arm, and its readings reach the trial team every day, through remote patient monitoring wearables. Once a month, a nurse visits his home to take blood. Every week, he answers a short questionnaire in Tamil through eCOA.
Most trials are not fully remote. They are hybrid. The patient visits the hospital for the first visit, for scans and for the final visit, and does the rest from home. The DCT platform keeps track of which visit happens where.
Running a trial at home raises its own questions. The trial team must be sure that the person answering is the patient. A delivered medicine must stay at the right temperature, as in any cold chain. And the hospital's trial doctor must still review every reading, because the doctor stays responsible for the patient's safety.
Some drug companies also find patients through a doctor community platform, which tells doctors about trials that their patients could join. The idea of measuring the body at home is explained in remote patient monitoring.