scholarly journals Magnitude and Pattern of Placebo Response in Clinical Trials of Oral Antihyperglycemic Agents: Data From the U.S. Food and Drug Administration, 1999–2015

Diabetes Care ◽  
2018 ◽  
Vol 41 (5) ◽  
pp. 994-1000 ◽  
Author(s):  
Arif Khan ◽  
Kaysee Fahl Mar ◽  
Joshua Schilling ◽  
Walter A. Brown
Keyword(s):  
Clinical Trials ◽  
Drug Administration ◽  
Food And Drug Administration ◽  
Placebo Response ◽  
Oral Antihyperglycemic Agents ◽  
Antihyperglycemic Agents ◽  
The U.S

Comments on the Draft Guidance on “Adaptive Design Clinical Trials for Drugs and Biologics” of the U.S. Food and Drug Administration

2010 ◽  
Vol 20 (6) ◽  
pp. 1125-1131 ◽  
Author(s):  
Werner Brannath ◽  
Hans Ulrich Burger ◽  
Ekkehard Glimm ◽  
Nigel Stallard ◽  
Marc Vandemeulebroecke ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Drug Administration ◽  
Adaptive Design ◽  
Food And Drug Administration ◽  
Draft Guidance ◽  
The U.S

scholarly journals The Clinical Trials Transformation Initiative: Methodology supporting the mission

2018 ◽  
Vol 15 (1_suppl) ◽  
pp. 13-18 ◽  
Author(s):  
Amy Corneli ◽  
Zachary Hallinan ◽  
Gerrit Hamre ◽  
Brian Perry ◽  
Jennifer C Goldsack ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Drug Administration ◽  
Food And Drug Administration ◽  
Public Private Partnership ◽  
Private Partnership ◽  
Key Stakeholders ◽  
Duke University ◽  
Fit For Purpose ◽  
Evidence Gathering ◽  
The U.S

The mission of the Clinical Trials Transformation Initiative, a public–private partnership co-founded by the U.S. Food and Drug Administration and Duke University, is to develop and drive adoption of practices that will increase the quality and efficiency of clinical trials. The Clinical Trials Transformation Initiative works collaboratively with key stakeholders, implements “fit-for-purpose” evidence-gathering projects, and develops actionable recommendations and tools to address the challenges faced by the clinical trials enterprise. In pursuit of its mission, The Clinical Trials Transformation Initiative follows an innovative and collaborative, five-step methodology: (1) state the problem and identify impediments to research, (2) gather evidence to identify gaps and barriers, (3) explore results by analyzing and interpreting findings, (4) finalize solutions by developing recommendations and tools, and (5) drive adoption through disseminating and implementing recommendations and tools. This article describes each step of the Clinical Trials Transformation Initiative's methodology, with a specific focus on describing the evidence-gathering activities.

scholarly journals THE STATE OF THE NATION: A 50-STATE COVID-19 SURVEY REPORT #9: WILL AMERICANS VACCINATE THEMSELVES AND THEIR CHILDREN AGAINST COVID-19?

2020 ◽  
Author(s):  
Roy H. Perlis ◽  
David Lazer ◽  
Katherine Ognyanova ◽  
Matthew Baum ◽  
Mauricio Santillana ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Drug Administration ◽  
Food And Drug Administration ◽  
District Of Columbia ◽  
The State ◽  
Phase Iii ◽  
Phase Iii Clinical Trials ◽  
Survey Report ◽  
The U.S

At least 5 companies have launched Phase III clinical trials of COVID-19 vaccines, the final step before seeking approval from the U.S. Food and Drug Administration (FDA). According to NIAID director Anthony Fauci, vaccines may be widely available in the U.S. by spring 2021 if these trials are successful.But should these vaccines become available, will Americans accept them? Between July 10 and July 26, we surveyed 19,058 adults in all 50 U.S. states and the District of Columbia. We asked about the likelihood that they would seek vaccination for themselves, and for their children. We also asked about the factors that would influence their decision making.We find that, overall, 66% of adults would be somewhat or extremely likely to vaccinate themselves; 66% would be somewhat or extremely likely to vaccinate their children. These rates vary markedly between states, as shown on the figure below.

HIV

2018 ◽  
Author(s):  
Joshua M. Sharfstein
Keyword(s):  
Public Health ◽  
Drug Administration ◽  
Food And Drug Administration ◽  
Research Process ◽  
National Institutes Of Health ◽  
Health Agencies ◽  
Act Up ◽  
The U.S

The emergence of AIDS in the early 1980s caused a profound crisis for federal health agencies, particularly the National Institutes of Health (NIH) and the U.S. Food and Drug Administration (FDA). Activists in ACT UP, charging that these agencies were failing patients with AIDS, initiated a series of escalating protests. NIH officials, led by Dr. Anthony Fauci, began to talk with the advocates and make major changes in the research process. However, over at the FDA, a protest involving the arrest of hundreds of AIDS activists undermined the agency’s public health image. Eventually, under a new commissioner, the FDA earned back the trust of activists.

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