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A comparison of screening methods in two early phase oral leukoplakia clinical trials
Author(s) -
Rosas RR,
Cole KA,
Darrah L,
Rohrer MD,
Rhodus NL,
Ondrey FG
Publication year - 2012
Publication title -
oral diseases
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.953
H-Index - 87
eISSN - 1601-0825
pISSN - 1354-523X
DOI - 10.1111/j.1601-0825.2012.01934.x
Subject(s) - medicine , clinical trial , leukoplakia , oral leukoplakia , dysplasia , accrual , randomized controlled trial , oral medicine , dermatology , cancer , dentistry , accounting , earnings , business
Oral Diseases (2012) 18 , 720–723 Objectives/Introduction: Clinical trial accrual for oral dysplasia is difficult in the United States 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 and screened by examination and biopsy. For the second clinical trial, we established a preneoplastic lesions clinic and teaching and communications network with regional oral healthcare 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 healthcare professionals who are likely to examine leukoplakia patients improved accrual to the second clinical trial.