What is it about?
The barriers to enrollment in a clinical trial, especially oncology trials are varied. Despite these barriers, patients who choose to consent and participate may fail screening due to multiple reasons and hence, are unable to get potential benefits of participating in a trial. High screen failure rates also lead to increased time, resources and costs during the conduct of a trial. There are few published studies which have reported different reasons for screen failure. However, no such studies have been conducted in India. Hence, we analyzed data of breast cancer patients who failed screening for participation in a clinical trial and tried to ascertain reasons for screen failure.
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Why is it important?
An increased number of screen failure patients in a clinical trial increases time and cost required for the recruitment. Also patients who chose to participate but failed screening are unable to get the potential benefits from participation in a trial. Assessment of reasons for screen failure can help reduce screen failure rates and improve recruitment. Reducing the number of screen failure patients will go a long way in controlling both time and cost.
Perspectives
India has a large patient pool for oncology studies, but the barriers to participation are also equally more. Hence data from such studies should be used to develop tools which can reduce screen failure rate. This will help our industry to be proactive and prepared to deliver high quality studies at reduced cost and time.
Dr Anuradha Kulkarni
Read the Original
This page is a summary of: Reasons why patients fail screening in Indian breast cancer trials, Perspectives in Clinical Research, January 2015, Medknow,
DOI: 10.4103/2229-3485.167100.
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