What Happens During a Clinical Trial?

Most clinical research studies proceed through the following stages.

Pre-Screening

Clinical trials employ different methods of recruiting study participants. The research center can review its existing databases of patients or medical charts to determine potentially eligible patients. Other recruiting methods include advertising in mass media (newspaper, radio, television, or Internet), public workshops, free health screenings, or forums.
The study staff then asks potential participants a series of questions to confirm participants' willingness to engage in the clinical study and verify whether they meet the criteria for participation or not.

Participant Information and Consent Form (PICF)

Once you pass the pre-screening, you will be scheduled for an appointment at the research site and meet with a member of the research team. Prior to initiation of any clinical screening procedures, you will be asked to sign a PICF. This document provides a detailed overview of the study, the possible risks and benefits, emergency contacts, and your rights as a research participant. The informed consent process also allows asking any questions you might have about participating in the study. You will receive a copy of the signed PICF to take home and keep for your records.

Screening Visit

After you have given consent to participate in the clinical trial and signed the PICF, you will be assigned screening procedures. They are designed to determine if you meet the specific inclusion and exclusion criteria for the clinical research study you decided to join. The screening process includes completing questionnaires and answering a series of questions about your medical history, current and previous treatments. To confirm that you meet the study’s requirements, you will have to undergo a physical exam, electrocardiogram (ECG), blood and urine tests to assess your general health. The investigational product is not usually received during the screening visit.

Study Visits (Treatment Visits)

Upon satisfying the study eligibility criteria (which include acceptable laboratory and medical test results), you will be asked to come to the clinic for a series of study visits, also called “treatment visits”. Some of these visits may be conducted virtually. Study participants start receiving the investigational product or the comparator product (sometimes a placebo) during treatment visits. The frequency and duration of visits vary for every study.

End of Study Visit

The End of Study visit occurs once you are no longer receiving investigational treatment. This stage requires the same or similar tests conducted before receiving the first dose of the investigational product. The research team will also discuss your follow-up treatment options (which may include standard of care treatment for your condition or open-label extension study of the investigational product). Please note that you may be asked to return to the research site for a follow-up safety visit if required.

Follow-up Safety Visit

The number of follow-up safety visits and intervals may differ according to the type of study. The purpose of this stage is to make sure that you are not experiencing any persistent side effects from the investigational product or the overall study participation.
 

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