Center for clinical and translational research COVID-19 clinical trial committee: The development of a review and prioritization matrix during a pandemic.

The rate at which the coronavirus disease (COVID-19) spread required a rapid response across many, if not all, industries. Academic medical centers had to rapidly evaluate, prioritize, and coordinate the multiple requests for clinical trial participation. This involved redirecting resources and developing a collaborative system for assessment, decision making, and implementation. Our institution formed a team with diverse representation from multiple stakeholders to review and prioritize all research protocols related to COVID-19. To accomplish this, a prioritization matrix was developed to help determine the order in which the protocols should be placed for consideration by the treating clinician. The purpose of the team was to review the COVID-19 clinical trials in the pipeline, prioritize those trials that best met the needs of our patients, oversee training and resource needs, and lead the formulation of procedures for integration with clinical care. Resources from the Clinical Research Unit were then allocated to support the swift execution of such studies. This manuscript describes that process, the challenges encountered, and the lessons learned on how to make all clinical trials more successful in a complex and dynamic environment.

Thrombocytosis is associated with a significant increase in the cancer specific death rate after radical nephrectomy.

PURPOSE: We have previously reported that patients with advanced renal cell carcinoma and a normal platelet count of 400,000/mm. have a 64% increase in life expectancy compared with those with thrombocytosis. We determined whether thrombocytosis was predictive of death from renal cell carcinoma after radical nephrectomy was performed with curative intent for early stage disease. MATERIALS AND METHODS: We reviewed the records of 204 patients with renal cell carcinoma who underwent radical nephrectomy with curative intent between June 1993 and January 2000 at Emory University Hospital. Survival, pathological grade and stage were recorded from the Emory Winship Cancer Institute tumor registry. Platelet counts were recorded and any patient with at least 1 platelet count of greater than 400,000/mm. was classified with thrombocytosis. Those with a platelet count of 400,000/mm. were classified with a normal platelet count. RESULTS: There were 26 patients with thrombocytosis and 178 patients with persistently normal platelet counts. The overall and cancer specific death rate in the 26 patients with thrombocytosis was 50% and 42%, respectively. The overall mean time between nephrectomy and death was 12.1 months in this group. The overall and cancer specific death rate in the 178 patients with a normal platelet count was 15.2% and 7.3%, respectively. Mean time to death was 22.6 months in this group. Differences in the overall and cancer specific death rates were highly statistically significant as well as clinically significant. These differences remained significant after controlling for grade, stage and histological type of cancer. CONCLUSIONS: This study documents the association of thrombocytosis with decreased survival in patients with renal cell carcinoma. In those who undergo nephrectomy for early stage renal cell carcinoma with a perioperative platelet count of greater than 400,000/mm. the cancer specific death rate from renal cell carcinoma is greater than 5 times the rate in patients with a persistently normal platelet counts after radical nephrectomy. The platelet count appears to be a new and powerful independent prognosticator in patients with renal cell carcinoma who undergo radical nephrectomy for presumed localized disease.