Enrolling by Invitation Clinical Trials
During the process of enrolling by invitation, participants are being or will be selected from a predetermined population of clinical trial participants. All clinical trials have particular participation guidelines. In order to determine which patient volunteers meet these guidelines and will be invited to enroll in a given clinical trial, researchers apply inclusion/exclusion criteria. These criteria are composed of social or medical standards which determine if a patient is fit to enter a trial. Inclusion/exclusion criteria are determined by a number of factors, including the following:
- Disease Type
- Disease Stage
- Previous Treatment History
- Other Medical Conditions
Inclusion/exclusion criteria are not used to reject participants. Researchers simply use the criteria to identify and keep appropriate participants safe during the trial. This process of extending invitation, based on the evaluation of these factors, is vital to ensuring reliable results are gathered and the trial is a success.
During this stage of a clinical trial, potential participants will also undergo informed consent, meaning they will learn key facts about the clinical trial before deciding whether or not to participate. Doctors and nurses involved in the study will explain the details. This process will continue throughout the study, providing information for patients the entire time.