Olorunfemi, Odunayo1; Akinboro, Oladimeji2; Balasire, Oluwaseyi3; Vuyyalla, Sowjanya1
1 Department of Medicine, Rochester General Hospital, Rochester, NY, USA
2 Department of Medicine Montefiore Medical Center, New Rocelle, NY, USA
3 Department of Medicine, Meharry Medical College, Nashville, TN, USA
Introduction: Our study sought to describe the characteristics and outcomes of the clinical trials in thyroid disease submitted to the FDA over a 23 year period.
Methods: We extracted 13320 registered clinical trials from the FDA clinical trials database over the 23-year period from 1990-2013. We identified thyroid malignancies and described the characteristics and outcomes of those trials. Our primary outcome was if the trials reported results on at least oneo f their primary objectives.
Results: There were a total of 13 in thyroid cancer with a total of 449 enrollees over the 23-years. The average number of enrollees were 34[SD19]. Majority[46.2%] of the trials were National Institute of Health [NIH] sponsored. Among all the trials, 11[84.6%] were Phase 2 studies. While only 4[30.8%] of the trials were terminated, only 4[30.8%] of had a result available for their primary outcomes. Among those that reported a result for their primary outcome, the average time from trial completion to reporting of the results was 24[SD 16.5] months. There was no statistically significant difference in the enrollment for studies reporting a result on their primary outcomes vs those that had no results on their primary outcomes.
Conclusions: A review of clinical trials submitted to the FDA over a 23 year period shows that trials in thyroid cancers are few and mostly do not meet or report the results for at least one of their primary outcomes. More studies are required to clarify and ameliorate the dearth in thyroid cancer clinical trials.