Most clinical trials require several visits at the study center. There are at least tree different types of study visits.
The first appointment at at the study center enables the doctor to assess wether you are suitable for participation. He or she will check several inclusion criteria and exclusion criteria that are clearly defined for each study. Before you are are enrolled in a clinical study, the doctors will explain the planned trial and will provide you with a written information sheet (“Patient Information”). You will learn about the required visits, about risks and benefits and about diagnostic procedures and treatments that are part of the study. You then need to sign the “Informed Consent Form” before your data and measurements can be used for scientific purposes. I many cases, a questionnaire will be used to capture your personal and health-related data. Sometimes, assessments and tests can follow (e.g. ECG, ultrasound, lung function testing) or biological samples are obtained (e.g. blood, urine, phlegm). In therapeutic studies that evaluate new treatment options, you are likely to receive the new drug (“Investigational Product”) that should be taken according to the doctor’s instructions.
Further appointments for study visits are booked in intervals of several weeks or months. The aim of theses consultations is to capture and document any health related changes. Ususally, you are asked to attend the study center for the appointments because further assessments, tests or sample collections are planned. In treatment studies, you may receive a new package of the investigational drug, while you have to hand in the old box.
End of trial visit
Most studies have pre-defined endpoints, for example if the new drug is not working as well as expected, or after one year of study participation. At this endpoint, an “End of Trial” visit is commonly performed, which again may include a physical examination, diagnostic test or other assessments. Some studies require a follow up by telephone after some years, if long term effects of drugs are in the focus of interest.