A comparison of screening methods in two early phase oral leukoplakia clinical trials

Abstract

Objectives/Introduction Clinical trial accrual for oral dysplasia is difficult in the U.S. and elsewhere. Patients with dysplastic oral leukoplakia progress to frank invasive carcinoma at a rate of 5-37% over 5 years. We compared two clinical trial screening efforts to hopefully devise better accrual strategies to these types of clinical trials. Methods For the first trial we identified 244 patients with dysplastic oral leukoplakia in our university database and a media campaign. Patients were notified, screened by examination and biopsy. For the second clinical trial we established a preneoplastic lesions clinic and teaching and communications network with regional oral health care professionals. Results Only one of 244 patients accrued to the first clinical trial through an organized screening effort based on database/medical records review. The second clinical trial accrued 16/30 screened patients through redirected efforts in teaching, communications and a preneoplastic lesions clinic. Conclusion We conclude that significant difficulties resulted from medical record /database review of leukoplakia patients as a screening method for leukoplakia clinical trial entry. We feel that persistent direct contact and education of health care professionals who are likely to examine leukoplakia patients improved accrual to the second clinical trial.