clinical-trial   62

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Demand cancer drugs that truly help patients
Already this year, the US Food and Drug Administration (FDA) has approved or extended the use of several cancer drugs that have yet to show they will prolong life or improve its quality. Unfortunately, there is no guarantee that such benefits will be demonstrated over time, and these drugs, like most cancer treatments, increase the risk of side effects such as diarrhoea and susceptibility to infection.

In my view, regulators should ensure that drugs benefit patients before allowing them to persist on the market.
Design  healthcare  cancer  clinical-trial  efficacy 
19 days ago by PieroRivizzigno
When is crossover desirable in cancer drug trials and when is it problematic? | Annals of Oncology | Oxford Academic
The use of crossover, as a design feature of randomized trials, is common, with reports indicating that up to 22% of all randomized controlled trials utilize this feature
healthcare  crossover  clinical-trial 
7 weeks ago by PieroRivizzigno
Press Announcements > FDA approves first cancer drug through new oncology review pilot that enables greater development efficiency
This is the first approval that FDA has granted as a part of two new pilot programs announced earlier this year that collectively aim to make the development and review of cancer drugs more efficient, while improving FDA’s rigorous standard for evaluating efficacy and safety.
new  clinical-trial  approval-process  healthcare 
12 weeks ago by PieroRivizzigno
Will Real World Performance Replace RCTs As Healthcare's Most Important Standard?
Randomized control trials – RCTs – rose to prominence in the twentieth century as physicians and regulators sought to evaluate rigorously the performance of new medical therapies; by century’s end, RCTs had become, as medical historian Laura Bothwell has noted, “the gold standard of medical knowledge,” occupying the top position of the “methodologic heirarch[y].”
clinical-trial  digital-health  trial 
november 2018 by PieroRivizzigno
How one pharmaceutical company is reinventing the clinical trial - STAT
Clinical trials are as essential today as drug discovery for bringing new drugs to market. But while new tools and technologies have helped advance techniques for new drug discovery, we’ve seen far less innovation in clinical trials. The process continues to be weighed down with regulatory paperwork, medical jargon, and participants’ time-intensive trips to trial sites.
healthcare  clinical-trial  trial  Jansen  Scripps  digital-health 
september 2018 by PieroRivizzigno
STAT 509: Clinical Trial
"This course is a survey of statistical methods and study design issues related to the testing of medical treatments. There are 19 lessons in this graduate level course"
statistics  biostatistics  clinical-trial  experiment-design 
september 2018 by arsyed
The Future Of Clinical Trials: The Promise Of AI And The Role Of Big Tech
Testing new drugs is a slow, expensive, and manual process. Artificial intelligence has the potential to disrupt every stage of the clinical trials process — from matching eligible patients to studies to monitoring adherence and data collection.
clinical-trial  digital-health  AI 
august 2018 by PieroRivizzigno
Should Tech Entrepreneurs Aspire To Fix Clinical Trials Or Reinvent Them?
To fix or to reinvent?  That’s the question many would-be innovators ask as they contemplate potential applications of technology to health. 
healthcare  clinical-trial  RCT  issue  redesign  Adaptive  silicon  David  Shaywitz  Forbes 
may 2018 by PieroRivizzigno
Software-Enabled Clinical Trials – Andrea’s Blog
Today, only 5% of the US population participates in clinical research. With the rise of new software tools that make research faster, cheaper, and more accessible and with a forward-looking FDA digital health team, the time is ripe for a clinical trial paradigm shift.
healthcare  digital-health  clinical-trial  taxonomy 
may 2018 by PieroRivizzigno
New Tech Tonics Podcast: Glen de Vries – A Series Of Quite Fortunate Events
Today, we’ll hear from Glen about the series of quite fortunate events that led to Medidata’s formation, the challenges he faced in breaking into a traditional conservative space, and the opportunities he sees at the intersection of precision medicine, digital health, and value based care. Listeners interested in learning more about Glen’s story are encouraged to listen to this interview with Glen on Janelle Anderson’s always-insightful Human Proof of Concept podcast.
healthcare  clinical-trial  silicon-randomized-trial 
may 2018 by PieroRivizzigno
CRI - Pancreatic Cancer Immunotherapy - Cancer Research Institute
Several approaches to immunotherapy for pancreatic cancer have shown promise in early clinical trials. These treatments can be broken into 7 main categories: checkpoint inhibitors/immune modulators, therapeutic vaccines, adoptive cell transfer, monoclonal antibodies, oncolytic viruses, adjuvant immunotherapies, and cytokines.
healthcare  cancer  pancreas  immunotherapy  clinical-trial 
april 2018 by PieroRivizzigno
Clinical trials test how Amazon’s Alexa can fit into healthcare | LinkedIn Premium Report, Healthcare | Pulse | LinkedIn
At least four clinical trials are examining the role that voice assistants like Amazon’s Alexa and Microsoft’s Cortana can play in improving health outcomes for patients, according to a LinkedIn analysis of ClinicalTrials.gov.
conversational-interface  clinical-trial  healthcare  digital-health  cancer 
april 2018 by PieroRivizzigno
Most medical practices are not parachutes: a citation analysis of practices felt by biomedical authors to be analogous to parachutes
In a 2003 paper in BMJ, the authors made the tongue-in-cheek observation that there are no randomized controlled trials (RCTs) of parachutes. This paper has been widely read, cited and used to argue that RCTs are impractical or unnecessary for some medical practices. We performed a study to identify and evaluate claims that a medical practice is akin to a parachute
parachute  clinical-trial  healthcare 
march 2018 by PieroRivizzigno
Why isn’t my doctor putting me forward for new cancer treatments? | Cancer raises many questions | The Guardian
When research breakthroughs hit the news, it can be frustrating for people with cancer if their treatment doesn’t keep pace. But there are many reasons doctors might opt for a more cautious approach, says David Cox
clinical-trial  cancer  guardian  immunotherapy  healthcare 
march 2018 by PieroRivizzigno

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