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On Randomized Trials and Medicine - Insight
If we had more proper randomization and tracing of these various approaches, we’d have more dexamethasones at hand. The WHO is leading some randomized trials at the moment, but we have little to none going on in the United States.As we learn more about some effective clinical practices, it’s getting harder to do novel ones: ethically, we cannot withhold known best practices from patients. It’s possible that we have found ourselves stuck at a local optimum, but much less than the upside potential we might have had, had we tried proper randomization from the beginning, when we had little to no idea what worked anyway, we could have conducted randomized trials. We should have.. This oversight will go down as yet another major failure of our health infrastructure and response to this pandemic.
On Randomized Trials and Medicine - Insight
Clinical trials for non-pharmaceutical interventions in health are relatively rare because there is little to no money to be made from recommending them. Conversely, drugs which require trials to go on the market are sponsored heavily by pharmaceutical companies.
Industrial n-of-1
The N-of-1 trials propose replacing large-scale trials of whole groups with methodical study of individual patients. However, the requirement to provide specific treatment to different subgroups of patients will make clinical trials more complex, so the industry needs to redesign how it interacts with patients. CROs will need to establish expert teams to structure and run precision-medicine-oriented trials for their sponsor clients.
Funding Trends for Clinical Trials in ClinicalTrials.gov | Research, Methods, Statistics | JAMA | The JAMA Network
In 2005, registration of trials became required for publication in major journals. Registration is also required for trials that meet the definition of an “applicable clinical trial” from the US Food and Drug Administration Amendments Act 801 and that were either initiated after September 27, 2007, or initiated on or before that date and were still ongoing as of December 26, 2007. There are legal repercussions if sponsors or principal investigators do not register accurately.
We hypothesized that the number of NIH-funded trials has decreased. We investigated trends in funding of trials using the NIH-built database, ClinicalTrials.gov, with a focus on NIH and industry funding.
Manufacturing the truth: from designing clinical trials to publishing trial data (PDF Download Available)
During the development of a new drug, manufacturers sponsor
(or act as authors of ) articles on the clinical trials of the new
drug, and these articles are submitted to medical journals.
Publication of these articles acts as an essential tool for
advertising to the medical community who will be the future
prescribers of the new drug. Richard Smith, a former editor of
The BMJ, considered that medical journals are “an extension
of the marketing arm of pharmaceutical companies” (4). To
illustrate, at an estimated cost of up to US$ 836,000, Merck &
Co. purchased 900,000 reprints of the VIGOR trial article from
the NEJM to circulate to doctors to promote Vioxx® (5,6).
Wilson (7) argues that in the public interest, the potential for
capture of medical journals represented by this commercial
role must be acknowledged and addressed.
