In a clinical research, patients are the most important key to a study. Subject retention is vital for data integrity, and lack of subject participation can have costly delays for the Sponsor. Since research sites spend a great deal of time and effort finding qualified subjects, they should also be equipped with reasons subjects withdraw to help prevent this from happening.
In ACRP’s Monitor Journal, Volume 26: Issue 4, an interesting piece by Carmen R. Gonzales, JD was published regarding this topic. The article, “Study Withdrawals: Follow the Reason to Find the Solution,” stated the most common reasons for subject withdrawal include Personal Reasons, Health and Safety, Non-compliance, Lost to follow-up and Randomization errors.
In considerations of these, consider the following examples as thought exercises for reducing their occurrence:
- Personal Reasons
- This is sited as the primary reason for subjects leaving a study. Personal reasons can include death of a loved one, relocation, loss of income, marriage/divorce or change in job. If the research staff is aware of the subject’s personal problems that are effecting study participation, they can offer assistance. For instance, if the subject started a new job and can not make day appointments the coordinator may be able to offer evening or weekend appointments to retain the subject.
- Health and Safety
- A thorough medical history review at screening can help identify health problems the subject may have throughout the study. If the study medication is known to cause weight gain, enrolling a patient who struggles with obesity may not be the best decision as this patient may withdraw later in the study if they are unhappy with the side effect.
- As stated in the article, study fatigue (when patients tire of their study duties) is the main reason for non-compliance. If the study is particularly lengthy, the study team should discuss the patient’s willingness to comply with all study related procedures stressing the length and rigorous requirements prior to the subject enrolling. Subjects may tire over time of taking study medication daily or returning for monthly follow-up visits.
- Lost to follow-up
- Subjects who are lost to follow-up typically become the responsibility of the research coordinator. It is her job to start contacting the patient right after the missed visit. Standard practice is calling three times before declaring the subject lost to follow-up. Attempting to call at different hours in the day may help. Leaving a friendly message with words of encouragement is also a good idea. To prevent lost to follow-up due to phone number or address change, confirm this information at each visit.
- Randomization errors
- Knowing inclusion/exclusion criteria prior to enrolling a subject can help prevent randomization errors which can lead to subject withdrawal. If history of seizure disorder is an exclusion criteria, it would be important to dig a little deeper if the subject was on an anti-seizure medication.
What are your experiences with handling the issue of study withdrawals? How do you ensure subject retention? Share your thoughts below!
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