When a patient comes into a facility for a clinical research study, it can look and feel a lot like going to a regular appointment with your doctor. For example, you check in at a front desk, fill out paperwork, someone checks your vitals signs, maybe you have bloodwork done, you meet with a doctor to see how things are going, you may be given medications or changes to your medications.
While there are a lot of similarities, the key difference is that medical treatment is intended to benefit and help you while using accepted procedures and products, whereas clinical research is intended to learn about a medication to potentially help patients in the future. This key difference drives how patients are monitored and followed up with by the clinic. This difference also affects what you as a patient can expect from the clinic and what the clinic expects of you.
For example, say you go to your doctor because you are not feeling well. The doctor may prescribe you pills with medication and tell you to come back in if you are not getting any better. You pick up your prescription, take the pills, and if you feel better you never go back to the doctor.
On the other hand, if you are given pills as part of a clinical trial or clinical research study, the clinic may stay in touch regularly by phone or have you come back to the clinic regularly to see how you are doing. Even when you are almost done taking the pills and possibly feeling much better, why is the clinic still asking you to come back for another visit?
In regular medical care, the medical community generally knows what works to treat a specific condition, so the doctor does not necessarily need to see you again unless you let the doctor know you are still feeling bad. But with clinical research, it is not yet known if someone will get better or by how much. So it is important for you to go back to the clinic for the follow up visits so the doctors can see how you are doing now compared to before. What you report to the study doctor, as well as the results of other tests/assessments may do, will inform the study team if and how well the particular treatment works or not.
There are many other differences between clinical research and medical treatment, which you can see on the FDA’s website here: https://www.fda.gov/ForPatients/ClinicalTrials/ClinicalvsMedical/default.htm