{"id":494189,"date":"2024-01-23T16:10:30","date_gmt":"2024-01-23T21:10:30","guid":{"rendered":"https:\/\/platohealth.ai\/the-difference-between-screening-and-enrollment-in-clinical-trials\/"},"modified":"2024-01-23T16:18:14","modified_gmt":"2024-01-23T21:18:14","slug":"the-difference-between-screening-and-enrollment-in-clinical-trials","status":"publish","type":"post","link":"https:\/\/platohealth.ai\/the-difference-between-screening-and-enrollment-in-clinical-trials\/","title":{"rendered":"The Difference Between Screening and Enrollment in Clinical Trials","gt_translate_keys":[{"key":"rendered","format":"text"}]},"content":{"rendered":"

Clinical trial screening is one piece of the overall patient enrollment period. The screening phase immediately follows the recruitment period<\/a>, during which a potential candidate has gone through pre-screening<\/a>, has gotten their first visit scheduled with the research team and has learned more about the trial and about informed consent. Now, screening stands between that trial candidate and official enrollment. But what is the difference between screening and enrollment in clinical trials?<\/p>\n

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\"recruitment-enrollment-funnel\"<\/p>\n

What happens during clinical trial screening?<\/span><\/h2>\n

Screening visits require a deeper assessment of whether a patient meets the inclusion\/exclusion criteria in a protocol. Before screening can begin, the patient needs to sign the informed consent form<\/a> to signify that they understand the study\u2019s purpose, benefits, and risks, and they are voluntarily choosing to participate in the trial.
Once screening begins, the patient generally undergoes a series of evaluations, including a physical examination as well as any necessary lab tests or diagnostic tests such as blood tests and imaging. Screening ensures the patient is eligible to receive the investigational product safely and in a way that produces meaningful data to help researchers understand the efficacy of the product.<\/p>\n

When screening a patient, the research site also collects baseline data that can function as a reference point when assessing changes as each patient moves forward in the trial. Baseline data can include medical history and health parameters.<\/p>\n

How is a patient officially enrolled in a clinical trial?<\/span><\/h2>\n

A patient enrolls<\/a> in the clinical trial once they have successfully undergone screening, and once the study team confirms that the patient has met all inclusion\/exclusion criteria. Usually, the site team will verbally confirm with the patient that they have been enrolled and randomized, when applicable. <\/p>\n

If this is an open-label clinical trial, in which researchers and participants know which product or intervention is being administered, the patient will be informed which arm they were randomized to. If this is a double-blind study in which neither researchers nor participants know which product or intervention is being administered, the patient will not be informed which arm they were randomized to.<\/p>\n

How can sites and sponsors improve pre-screening and screening processes to increase enrollment in clinical trials?<\/span><\/h2>\n

Because the screening pipeline determines which patients actually enroll in a trial, it\u2019s critical to ensure that eligible patients aren\u2019t falling through the cracks during \u2013 and leading up to \u2013 this phase. Earlier (and secure) data-sharing<\/a> between sites and their sponsors on a digital platform can speed up the identification of factors affecting successful enrollment such as:<\/p>\n