Pfizer Inc. (NYSE: PFE) has announced an update of its clinical trial data access policy that will simplify and broaden access to information.
Dani Saade's insight:
It is one principle of the investigation with humans and clinical trials to give enough access to the results of the trials to the patients that have participated on it. I think it is a possitive thing that Pfizer makes it easy for patients to have this information because one big issue is that is not easy to understand for most of them the medical terms.
SC issues notice to Centre PATH on clinical trials Jagran Post The petitioner alleged that there were serious failures on the part of PATH (Program for Appropriate Technology in Health (PATH)) and Indian Council of Medical Research (ICMR) in...
Want data on drugs? Look for clinical study reports KFGO German researchers found that so-called clinical study reports produced by pharmaceutical companies had complete information on 86 percent of study outcomes that are relevant to patients.
India was once hailed as a fertile ground for clinical trials with a large drug-naïve population. Today, the international community, and its own apex court, is unconvinced.
On September 30, the Supreme Court directed the Union health ministry to halt clinical trials in 162 cases where it had given approval until it provided assurances on safety regimes. It has given two weeks to the ministry before announcing a formal ban on clinical trials in the country. Nearly 40 trials involving the US National Institutes of Health are also on hold.
The industry has already shrivelled. McKinsey had projected the clinical trials industry in India to reach $1 billion by 2010, but it was under $500 million in 2012.
As India struggles to clean up its regulatory mess, it should heed the latest study published in PLOS Medicine which shows that clinical trial outcomes are more complete in unpublished reports than in published sources (which contain less information about the benefits and potential harms of an intervention).
The Indian clinical trial registry says those conducting trials “are expected to regularly update the trial status” but the reality is far from it. This is a global phenomenon, says the PLOS study.
Now that the health ministry is forced to submit a safety regimen, it may be a good idea to take a long-term view and make it mandatory for all institutions and drug companies to make trial data public.
Clinical Trials Continue, but Only at a Crawl New York Times WASHINGTON — The federal government has continued to enroll critically ill people in clinical trials at the National Institutes of Health since the government shutdown began last week,...
IBNLive Notice to Centre on unethical clinical trials Deccan Herald The Supreme Court on Monday sought the Centre's response on a public interest litigation (PIL) alleging that unethical clinical trials of human papilloma virus (HPV) vaccines were...
Data-sharing will benefit drug development, say EMA officials PharmaTimes Access to full, appropriately de-identified datasets from clinical trials can benefit the biopharmaceutical industry by improving the efficiency of drug development,...
I am not sure if skipping protocols to put drugs in market as soon as possible is the best solution to desperate pacients. It might work for those patients with no other hope, but I think that protocols are stablished with a good criteria and that are ment to be for some reason, I dont think that is a good solution, it would be better to keep going on clinical trials as always and follow steps.
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