Relationship between news media coverage of medical research and academic medical centers and people volunteering for clinical trials

2006 ◽  
Vol 32 (2) ◽  
pp. 196-198 ◽  
Author(s):  
Gary Mans ◽  
Christopher Stream
2018 ◽  
Author(s):  
Ann M Davis ◽  
Lawrence P Hanrahan ◽  
Alex F Bokov ◽  
Sarah Schlachter ◽  
Helena H Laroche ◽  
...  

BACKGROUND Electronic health records (EHRs) are ubiquitous. Yet little is known about the use of EHRs for prospective research purposes, and even less is known about patient perspectives regarding the use of their EHR for research. OBJECTIVE This paper reports results from the initial obesity project from the Greater Plains Collaborative that is part of the Patient-Centered Outcomes Research Institute’s National Patient-Centered Clinical Research Network (PCORNet). The purpose of the project was to (1) assess the ability to recruit samples of adults of child-rearing age using the EHR; (2) prospectively assess the willingness of adults of child-rearing age to participate in research, and their willingness (if parents) to have their children participate in medical research; and (3) to assess their views regarding the use of their EHRs for research. METHODS The EHRs of 10 Midwestern academic medical centers were used to select patients. Patients completed a survey that was designed to assess patient willingness to participate in research and their thoughts about the use of their EHR data for research. The survey included questions regarding interest in medical research, as well as basic demographic and health information. A variety of contact methods were used. RESULTS A cohort of 54,269 patients was created, and 3139 (5.78%) patients responded. Completers were more likely to be female (53.84%) and white (85.84%). These and other factors differed significantly by site. Respondents were overwhelmingly positive (83.9%) about using EHRs for research. CONCLUSIONS EHRs are an important resource for engaging patients in research, and our respondents concurred. The primary limitation of this work was a very low response rate, which varied by the method of contact, geographic location, and respondent characteristics. The primary strength of this work was the ability to ascertain the clinically observed characteristics of nonrespondents and respondents to determine factors that may contribute to participation, and to allow for the derivation of reliable study estimates for weighting responses and oversampling of difficult-to-reach subpopulations. These data suggest that EHRs are a promising new and effective tool for patient-engaged health research. INTERNATIONAL REGISTERED REPOR NA


2012 ◽  
Vol 40 (3) ◽  
pp. 467-481 ◽  
Author(s):  
Richard S. Saver

Conflicts of interest have been reduced to financial conflicts. The National Institutes of Health’s (NIH) new rules for managing conflicts of interest in medical research, the first major change to the regulations in over 15 years, address only financial ties. Although several commentators urged that the regulations also cover non-financial interests, the Department of Health and Human Services declined to do so. Similarly, the Institute of Medicine’s (IOM) influential 2009 Conflict of Interest Report focuses almost exclusively on financial conflicts. Institutional policies at academic medical centers and guidance from professional bodies and medical journals also primarily emphasize financial ties. Even broadly worded rules are applied more readily to financial ties than non-financial interests, such as the regulations that restrict institutional review board (IRB) members with conflicting interests from participating in protocol reviews.


Stroke ◽  
2016 ◽  
Vol 47 (suppl_1) ◽  
Author(s):  
Elan Guterman ◽  
Zachary D Threlkeld ◽  
Wade S Smith ◽  
Jay Chol Choi ◽  
Anthony S Kim

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.


JAMA ◽  
2005 ◽  
Vol 294 (11) ◽  
pp. 1367 ◽  
Author(s):  
Jordan J. Cohen ◽  
Elisa K. Siegel

Author(s):  
Nathaniel J Rhodes ◽  
Atheer Dairem ◽  
William J Moore ◽  
Anooj Shah ◽  
Michael J Postelnick ◽  
...  

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.


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