THE IMPORTANCE OF CONTROLLED CLINICAL TRIALS DEMONSTRATED—ONCE AGAIN

PEDIATRICS ◽  
1989 ◽  
Vol 84 (4) ◽  
pp. 693-693
Author(s):  
Student
Keyword(s):  
Clinical Trial ◽  
Heart Attack ◽  
Major Part ◽  
Telephone Interview ◽  
Heart Rhythm ◽  
Controlled Clinical Trials ◽  
Heart Attacks ◽  
Blood Institute ◽  
National Heart Lung ◽  
Major Clinical Trial

Two drugs used to treat heart rhythm irregularities in more than 200,000 Americans increased the risk of heart attack and death in a major clinical trial, Federal health officials said today. The Food and Drug Administration said it was immediately advising doctors to stop prescribing the drugs, Tambocor and Enkaid, for mild or moderate heart rhythm irregularities, or arrhythmias. The National Heart, Lung and Blood Institute said that more than twice as many patients getting the drugs suffered heart attacks or death as those taking dummy pills, making it necessary to suspend a major part of the test three years early. "Absolutely, unequivocally, this trial was a success because we have identified two drugs of a type that are more dangerous than the disease they are supposed to treat," Dr. Killip said in a telephone interview.

scholarly journals Streamlining statistical reproducibility: NHLBI ORCHID clinical trial results reproduction

JAMIA Open ◽  
2022 ◽  
Vol 5 (1) ◽  
Author(s):  
Arnaud Serret-Larmande ◽  
Jonathan R Kaltman ◽  
Paul Avillach
Keyword(s):  
Clinical Trial ◽  
Peer Review Process ◽  
Application Programming Interface ◽  
Data Repository ◽  
Practical Implementation ◽  
Media Audiences ◽  
Blood Institute ◽  
National Heart Lung ◽  
Application Programming ◽  
Clinical Trial Results

Abstract Reproducibility in medical research has been a long-standing issue. More recently, the COVID-19 pandemic has publicly underlined this fact as the retraction of several studies reached out to general media audiences. A significant number of these retractions occurred after in-depth scrutiny of the methodology and results by the scientific community. Consequently, these retractions have undermined confidence in the peer-review process, which is not considered sufficiently reliable to generate trust in the published results. This partly stems from opacity in published results, the practical implementation of the statistical analysis often remaining undisclosed. We present a workflow that uses a combination of informatics tools to foster statistical reproducibility: an open-source programming language, Jupyter Notebook, cloud-based data repository, and an application programming interface can streamline an analysis and help to kick-start new analyses. We illustrate this principle by (1) reproducing the results of the ORCHID clinical trial, which evaluated the efficacy of hydroxychloroquine in COVID-19 patients, and (2) expanding on the analyses conducted in the original trial by investigating the association of premedication with biological laboratory results. Such workflows will be encouraged for future publications from National Heart, Lung, and Blood Institute-funded studies.

National Heart, Lung, and Blood Institute cardiovascular clinical trial perspective

2020 ◽  
Vol 224 ◽  
pp. 25-34
Author(s):  
Gail D. Pearson ◽  
George A. Mensah ◽  
Yves Rosenberg ◽  
Catherine M. Stoney ◽  
Katherine Kavounis ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Blood Institute ◽  
National Heart ◽  
National Heart Lung
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