ASH Clinical News September 2015 | Page 35

CLINICAL NEWS blood samples were obtained from 56 healthy adult volunteers, which were then driven to a flight site an hour away from the hospital. Half of the samples were loaded onto the drone, and half remained stationary on the ground. The samples loaded on the drone then flew on a mile loop and stayed in the air from six to 38 minutes. All samples were then driven back to the laboratory where they underwent 33 common blood tests. The researchers did not detect much of a difference between the samples that had been flown on the drones and those that stayed on the ground. The overall concordance was 97 percent, and the length of the drone flight had no impact on the blood sample results. Only one test, for total carbon dioxide, had results that varied. According to Timothy Amukele, MD, PhD, a pathologist at Johns Hopkins who was involved in the study, said, “If we now have a cheaper way to move samples, it is a good thing, especially for patients who are hard to reach, whether they live in rural areas or places without good roads.” Next steps for this study include applying this concept to a pilot study with real patients in real clinical settings. Source: Amukele TK, Sokoll LJ, Pepper D, et al. Can unmanned aerial systems (drones) be used for the routine transport of chemistry, hematology, and coagulation laboratory specimens? PLoS One. 2015 July 29. [Epub ahead of print] FDA Proposes New Quality Monitoring Protocol to Prevent Drug Shortages The U.S. FDA, in conjunction with the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research, issued a draft T:7” Table 6: Grade 3/4 Adverse Reactions Reported in ≥2% Patients and With a ≥1% Difference in Proportion of Patients Between the REVLIMID/dexamethasone and Placebo/dexamethasone groups System Organ Class/ Preferred Term REVLIMID/Dex# Placebo/Dex# (N=353) (N=350) n (%) n (%) Eye Disorders Cataract 6 (1.7) 1 (0.3) Cataract Unilateral 5 (1.4) 0 (0.0) Psychiatric Disorder Depression 10 (2.8) 6 (1.7) Venous and Arterial Thromboembolism [see Boxed Warning, Warnings and Precautions (5.4)] Deep vein thrombosis (DVT) was reported as a serious (7.4%) or severe (8.2%) adverse drug reaction at a higher rate in the REVLIMID/dexamethasone group compared to 3.1 % and 3.4% in the placebo/dexamethasone group, respectively in the 2 studies in patients with at least 1 prior therapy with discontinuations due to DVT adverse reactions reported at comparable rates between groups. In the NDMM study, DVT was reported as an adverse reaction (all grades: 10.3%, 7.2%, 4.1%), as a serious adverse reaction (3.6%, 2.0%, 1.7%), and as a Grade 3/4 adverse reaction (5.6%, 3.7%, 2.8%) in the Rd Continuous, Rd18, and MPT Arms, respectively. Discontinuations and dose reductions due to DVT adverse reactions were reported at comparable rates between the Rd Continuous and Rd18 Arms (both <1%). Interruption of REVLIMID treatment due to DVT adverse reactions was reported at comparable rates between the Rd Continuous (2.3%) and Rd18 (1.5%) arms. Pulmonary embolism (PE) was reported as a serious adverse drug reaction (3.7%) or Grade 3/4 (4.0%) at a higher rate in the REVLIMID/dexamethasone group compared to 0.9% (serious or grade 3/4) in the placebo/dexamethasone group in the 2 studies in patients with, at least 1 prior therapy, with discontinuations due to PE adverse reactions reported at comparable rates between groups. In the NDMM study, the frequency of adverse reactions of PE was similar between the Rd Continuous, Rd18, and MPT Arms for adverse reactions (all grades: 3.9%, 3.3%, and 4.3%, respectively), serious Myocardial infarction was reported as a serious (1.7%) or severe (1.7%) adverse drug reaction at a higher rate in the REVLIMID/dexamethasone group compared to 0.6 % and 0.6% respectively in the placebo/ dexamethasone group. Discontinuation due to MI (including acute) adverse reactions was 0.8% in REVLIMID/dexamethasone group and none in the placebo/dexamethasone group. In the NDMM study, myocardial infarction (including acute) was reported as an adverse reaction (all grades: 2.4%, 0.6%, and 1.1%), as a serious adverse reaction, (2.3%, 0.6%, and 1.1%), or as a severe adverse reaction (1.9%, 0.6%, and 0.9%) in the Rd Continuous, Rd18, and MPT Arms, respectively. Stroke (CVA) was reported as a serious (2.3%) or severe (2.0%) adverse drug reaction in the REVLIMID/dexamethasone group compared to 0.9% and 0.9% respectively in the placebo/dexamethasone group. Discontinuation due to stroke (CVA) was 1.4% in REVLIMID/dexamethasone group and 0.3% in