P.Mean: Monitoring refusals and exclusions in a clinical trial (created 2008-05-01)

Stage 1: A volunteer could makes an initial contact, but does not set up a first appointment, cancels the first appointment, or fails to show up at the first appointment.
Stage 2: At the initial appointment, the volunteer reviews the details of the study and does not want to join the study.
Stage 3: After the consent form is signed, the volunteer gets some medical tests done. These tests show that the patient is ineligible for the trial.

Monitoring refusals and exclusions in a clinical trial (created 2008-05-01 with major update on 2008-05-29).

Someone sent me an email asking about the work that Byron Gajewski and I have done on monitoring accrual patterns in clinical trials. She had been doing something similar at her job and wanted to see if we could collaborate.

In her situation, the major issue was

the number of patients who made an initial contact but did not keep their first appointment,

the number of patients who kept the appointment, but refused to sign the consent form once they realized what the study was about, and

the number of patients who did sign the consent form, but who did not meet the inclusion criteria once the initial screening was done.

This webpage was originally published at the StATS website, which is currently unavailable. There is a dispute about the ownership of these pages, so I am only able to include a brief excerpt from this page.

This work is licensed under a Creative Commons Attribution 3.0 United States License. This page was written by Steve Simon and was last modified on 2008-11-26. Need more information? I have a page with general help resources. You can also browse for pages similar to this one at Category: Accrual problems in clinical trials.