Recruitment and retention in clinical trials of the elderly.
Special considerations for recruiting older patients
Why this item may be useful
This article describes strategies used to increase recruitment in a Veterans Affairs (VA) Administration clinical trial of two antiepileptic drugs. Strategies included modifying inclusion criteria by lowering the eligibility age from 65 to 60 years, replacing five trial sites that had poor recruiting records, and extending the patient recruitment period by 3 months. These strategies added approximately 100 patients to the study.
The most common reason for non-participation was refusal of family members to allow the patients to enroll. Other factors that prevented enrollment included comorbidities, transportation barriers, denial of a seizure diagnosis, and unwillingness of nursing and assisted living facilities to administer study medication. Retention was primarily influenced by side effects, frequent hospitalizations, and admission to residential facilities.