remote sampling and virtual clinical trials: a glance into the future
When Nebuchadnezzar was King in Babylon, he tried to force Daniel and three companions to eat the royal diet of wine and meat. Daniel refused and the King let him eat nothing but vegetables and water. After ten days, Daniel looked better nourished than his three friends. The King changed the royal diet. This was probably the first clinical trial.
In 1747, ship doctor James Lind tried an experiment on men with scurvy. He divided them into groups and gave each group a different remedy - such as vinegar, cider, sulfuric acid mixed with alcohol, and oranges. The men who received two oranges a day were ready to get back to work in a few days. Shortly thereafter every ship carried oranges or limes to prevent scurvy.
Since then clinical trials have evolved into complex randomized, double-blind experiments, carefully regulated to prevent patient harm and assess efficacy. But while the scientists are concerned about patient safety, patient inconvenience is also an issue. Patients have to drive miles on their own time to research centers or laboratories for tests. They have to sit in uncomfortable chairs in waiting rooms, bored and restless and thinking about what they could be doing at home. These considerations create issues around adherence, compliance, and subject retention and can potentially cause participants to drop out of studies.
Now there's a new concept: the virtual, siteless clinical trial. Participants do not have to travel to distant centers. They do their own testing at home. They report outcomes to the scientists using smartphone apps and the technologies of telemedicine.
One of the most difficult aspects of clinical studies has always been finding the requisite number of appropriate patients. That just got much easier. No matter where they are, the new technique can enroll them. Geography is not a problem. And the time necessary to comply with the study is minimal compared to standard clinical trials.
One very important advance that can significantly streamline the new wave of virtual clinical trials is microsampling. Instead having blood collected in a laboratory or clinic, participants themselves draw 10, 20, or 30 µl from a drop of blood, obtained by finger-stick. The blood is collected in containers that are then mailed to the center. The result: less pain, less stress, less time, and less blood. And patients prefer it.
Welcome to the modern era of clinical trials that not only advance medicine and knowledge, but make their subjects' lives easier as well.
Topics: Clinical Trials