Academic medical centers, private industry, and clinical trials: how do we achieve fairness, objectivity, and balance?

2006 ◽  
Vol 18 (3) ◽  
pp. 233-235
Author(s):  
Raymond T. Foster
Keyword(s):  
Clinical Trials ◽  
Academic Medical Centers ◽  
Private Industry ◽  
Medical Centers ◽  
Academic Medical

Abstract WMP9: National Trends in the Use of Endovascular Stroke Treatment at Academic Medical Centers (2009-15)

Stroke ◽  
2016 ◽  
Vol 47 (suppl_1) ◽  
Author(s):  
Elan Guterman ◽  
Zachary D Threlkeld ◽  
Wade S Smith ◽  
Jay Chol Choi ◽  
Anthony S Kim
Keyword(s):  
Clinical Trials ◽  
Ischemic Stroke ◽  
Acute Ischemic Stroke ◽  
Temporal Trends ◽  
Academic Medical Centers ◽  
Stroke Treatment ◽  
Negative Results ◽  
Medical Centers ◽  
Academic Medical ◽  
The Impact

Objective: To characterize temporal trends in the use of endovascular treatment (EVT) for acute ischemic stroke at academic medical centers in response to recent clinical trials. Background: Although endovascular devices for stroke were first cleared for marketing in 2004, initial clinical trials in 2013 failed to demonstrate efficacy and subsequent clinical trials beginning in 2014 were strongly positive. The impact of these data on practice patterns at academic medical centers, which perform most EVTs, is unknown. Methods: We identified all acute ischemic stroke hospitalizations at academic medical centers that were members in the University HealthSystem Consortium from October 2009 to July 2015 using International Classification of Disease, 9th revision codes 433.x1, 434.x1, and 436 for stroke and procedure code 39.74 for EVT. We compiled quarterly data on the number and proportion of stroke hospitalizations using EVT and we used segmented log-linear regression to identify temporal trends and to evaluate changes in trends at prespecified time points corresponding to the quarter in which pivotal trials were first reported. Results: From 2009-15, we identified 357,973 acute ischemic stroke hospitalizations at 161 medical centers. The proportion of stroke hospitalizations using EVT was 1.5% in 2009 and grew by 25% a year (95% CI 21% to 29%) to reach 3.1% in 2013. After negative results from the initial trials were reported in 2013, EVT use hovered between 2.5% and 2.7% (1% relative change per year; 95% CI -9% to +8%; p=0.004 for change in trend) until 2014 when the first positive trials were reported and EVT use jumped at a growth rate of 151% per year (95% CI 101% to 212%; p<0.001 for change in trend) to reach fully 4.7% of all stroke hospitalizations by 2015. Conclusion: The previously steady growth in EVT flattened in 2013, coincident with the initially negative results from clinical trials, but has dramatically increased since positive trials were first reported in 2014.

scholarly journals Multicenter point prevalence evaluation of the utilization and safety of drug therapies for COVID-19 at the onset of the pandemic timeline in the United States

2021 ◽  
Author(s):  
Nathaniel J Rhodes ◽  
Atheer Dairem ◽  
William J Moore ◽  
Anooj Shah ◽  
Michael J Postelnick ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Drug Therapy ◽  
Supportive Care ◽  
The United States ◽  
Primary Objective ◽  
Point Prevalence ◽  
Medical Centers ◽  
Academic Medical ◽  
History Of ◽  
Secondary Objective

Abstract Disclaimer In an effort to expedite the publication of articles related to the COVID-19 pandemic, AJHP is posting these manuscripts online as soon as possible after acceptance. Accepted manuscripts have been peer-reviewed and copyedited, but are posted online before technical formatting and author proofing. These manuscripts are not the final version of record and will be replaced with the final article (formatted per AJHP style and proofed by the authors) at a later time. Purpose There are currently no FDA-approved medications for the treatment of coronavirus disease 2019 (COVID-19). At the onset of the pandemic, off-label medication use was supported by limited or no clinical data. We sought to characterize experimental COVID-19 therapies and identify safety signals during this period. Methods We conducted a non-interventional, multicenter, point prevalence study of patients hospitalized with suspected/confirmed COVID-19. Clinical and treatment characteristics within a 24-hour window were evaluated in a random sample of up to 30 patients per site. The primary objective was to describe COVID-19–targeted therapies. The secondary objective was to describe adverse drug reactions (ADRs). Results A total of 352 patients treated for COVID-19 at 15 US hospitals From April 18 to May 8, 2020, were included in the study. Most patients were treated at academic medical centers (53.4%) or community hospitals (42.6%). Sixty-seven patients (19%) were receiving drug therapy in addition to supportive care. Drug therapies used included hydroxychloroquine (69%), remdesivir (10%), and interleukin-6 antagonists (9%). Five patients (7.5%) were receiving combination therapy. The rate of use of COVID-19–directed drug therapy was higher in patients with vs patients without a history of asthma (14.9% vs 7%, P = 0.037) and in patients enrolled in clinical trials (26.9% vs 3.2%, P &lt; 0.001). Among those receiving drug therapy, 8 patients (12%) experienced an ADR, and ADRs were recognized at a higher rate in patients enrolled in clinical trials (62.5% vs 22%; odds ratio, 5.9; P = 0.028). Conclusion While we observed high rates of supportive care for patients with COVID-19, we also found that ADRs were common among patients receiving drug therapy, including those enrolled in clinical trials. Comprehensive systems are needed to identify and mitigate ADRs associated with experimental COVID-19 treatments.

Unplanned Reoperation and Implant Revision After Total Wrist Arthroplasty

Hand ◽  
2020 ◽  
pp. 155894471989881 ◽  
Author(s):  
Taylor M. Pong ◽  
Wouter F. van Leeuwen ◽  
Kamil Oflazoglu ◽  
Philip E. Blazar ◽  
Neal Chen
Keyword(s):  
Risk Factors ◽  
Implant Removal ◽  
Academic Medical Centers ◽  
Implant Design ◽  
Factors Associated ◽  
Medical Centers ◽  
Total Wrist Arthroplasty ◽  
Academic Medical ◽  
Related Risk ◽  
Wrist Arthroplasty

Background: Total wrist arthroplasty (TWA) is a treatment option for many debilitating wrist conditions. With recent improvements in implant design, indications for TWA have broadened. However, despite these improvements, there are still complications associated with TWA, such as unplanned reoperation and eventual implant removal. The goal of this study was to identify risk factors for an unplanned reoperation or implant revision after a TWA at 2 academic medical centers between 2002 and 2015. Methods: In this retrospective study, 24 consecutive TWAs were identified using CPT codes. Medical records were manually reviewed to identify demographic, patient- or disease-related, and surgery-related risk factors for reoperation and implant removal after a primary TWA. Results: Forty-six percent of wrists (11 of 24 TWAs performed) had a reoperation after a median of 3.4 years, while 29% (7 of 24) underwent implant revision after a median of 5 years. Two patients had wrist surgery prior to their TWA, both eventually had their implant removed ( P = .08). There were no risk factors associated with reoperation or implant removal. Conclusion: Unplanned reoperation and implant removal after a primary TWA are common. Approximately 1 in 3 wrists are likely to undergo revision surgery. We found no factors associated with reoperation or implant removal; however, prior wrist surgery showed a trend toward risk of implant removal after TWA.

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