Precision medicine (PM) offers opportunities for reducing the costs, burdens, and time associated with drug development. We examined time, number of trials, indications tested, and patient burden needed to achieve first U.S. Food and Drug Administration license for all five novel anticancer PM drugs and all 10 novel non-PM drugs receiving U.S. Food and Drug Administration approval during 2010–2014. The 15 drug portfolios encompassed 242 trials: 87 for PM drugs and 155 for non-PM drugs. Embase and MEDLINE databases were searched for all prelicensure clinical trials, and data on time, patient numbers, indications tested, and total treatment-emergent grade 3–5 adverse events were measured from the first trial of each drug. We did not find patterns suggesting greater efficiencies in PM compared with non-PM. Gains in efficiency for PM drug development may be offset by challenges with recruitment.
Introduction: Feedback devices for cardiopulmonary resuscitation (CPR) currently register compression rate, depth, recoil and land marking. There remains a gap in determining the impact of peripheral vascularization, blood pressure, and blood flow as a result of quality CPR compressions. Methods: Our team designed a closed-loop CPR mannequin model that represented the vascularization of a human, including peripheral lower limbs. A disposable, ultrasound bandage (Flosonics Flopatch™) was applied to measure the blood flow. The model consisted of a CPR mannequin and feedback software, pressure monitoring device, patient monitor, Polyvinyl chloride (PVC) tubing and connectors, siphon bulb, 3D printed parts and wood for stabilization, Kelly clamps, and water mixture to replicate blood. A full cost breakdown and set-up is provided. Results: 28 Basic Life Saving-trained individuals tested the device both clamped and unclamped to peripheral vasculature. CPR was performed for 5 minutes at 60bpm to mimic human heart rate with siphon bulb limitations. Findings demonstrate that pulse pressure mean was 69.9mmHg clamped and 65.0mmHg unclamped (p = 0.03), consistent with expected values anticipated during effective compressions. Blood flow velocity was statistically insignificant, and cannot be inferred on due to inconsistencies with the ultrasound bandage. Conclusions: The CPR vascularization prototype was effective in replicating blood pressures of a human adult circulatory system, including peripheral vasculature. There remains limitations to state the model was effective for replicating blood flow velocity with the Flopatch™, further testing is required. The use of Kelly clamps was effective in restricting blood flow to tube sections.
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