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Showing posts with label Research lounge. Show all posts
Showing posts with label Research lounge. Show all posts
Why FDA Drugs Kill People – Mind Control Report
Why do side effects not get discovered during clinical trials? Why do drugs get approved by the FDA, kill people have to be withdrawn from the market? Why do drug company constantly get sued over defective drugs? What’s wrong with pharmaceutical clinical trials?
How the FDA Approval Process Works
Why FDA Drugs Kill People
How the FDA Kills People
The 12 Facts Before Christmas about clinical resaerch
Eight Promises That Make Tomorrow Better Than Today..
You can be an analytical, data-driven, steely-eyed businessperson all you like, but business is ultimately about people. That means business is also about emotions: yours and those of the people you interact with.Want to make a huge difference in your life and in the lives of the people you care about, both professionally and personally? Promise yourself you’ll do these things every day:
1. “I will appreciate the under-appreciated.”
Some jobs require more effort than skill. Bagging groceries, delivering packages, checking out customers — the tasks are relatively easy. The difference is in the effort.All around you are people who work hard with little or no recognition. Vow to be the person who recognizes at least one of them every day. Do more than say “thanks” to a person who does a thankless job. Smile. Make eye contact. Exchange a kind word. Not only will you give respect, you’ll also gain the best kind of respect — the respect that comes from making a difference, however fleeting, in another person’s life.
2. “I will answer the unasked question.”
For a variety of reasons — maybe they’re hesitant, or insecure, or shy — people often ask a different question than the one they really want answered. (If you’re lacking in confidence, here are simple yet powerful ways to overcome your insecurity.) One employee might ask whether you think he should take a few business classes; what he really wants to know is whether you feel he has the potential to move up in the organization. He hopes you’ll say you do have potential… and he hopes you’ll share the reasons why. Or your husband might ask if you thought the woman at the party was flirting with him; what he really wants to know is if you still find him attractive. He hopes you’ll say you do… and he’ll love when you share the reasons why.
Behind many questions is an unasked question.
Pay attention so you can answer that question; that is the answer the other person doesn’t just want to hear… but needs to hear.
3. “I will not wait.”
You don’t have to wait to be discovered. You don’t have to wait for an okay. You don’t have to wait for someone else to help you. You can just do whatever you want to do.
Right now.
You may not succeed. But you don’t have to wait.
Don’t wait.
4. “I will give latitude instead of direction.”
You’re in charge. You know what to do. So it’s natural to tell your employees – or your kids — not only what to do but how to do it. In the process you stifle their creativity and discount their skills and intelligence. Letting another person decide how is the best way to show you respect their abilities and trust their judgment.In a command-and-control world, latitude is welcome freedom… and is a gift anyone can give.
5. “I will stop and smell my roses.”
You have big plans. You have big goals. You’re never satisfied, because satisfaction breeds complacency. So most of the time you’re unhappy because you think more about what you have notachieved, have not done, and do not have. Take a moment and think about what you do have, professionally and especially personally. At this moment you have more than at one time you ever thought possible. Sure, always strive for more… but always take a moment to realize that all the things you have, especially your relationships, are more important than anything you want to have.
Unlike a want, what you have isn’t a hope, a wish, or a dream. What you already have is real. And it’s awesome. And it’s yours.
Appreciate it.
6. “I will look below the surface.”
Sometimes people make mistakes. Sometimes they piss you off. When that happens it’s natural to assume they didn’t listen or didn’t care. But often there’s a deeper reason. They may feel stifled. They may feel they have no control. They may feel frustrated or marginalized or ignored or not cared for. If you’re in charge, whether at work or at home, you may need to deal with the mistake. But then look past the action for the underlying issues. Anyone can dole out discipline; vow to provide understanding and to actively helpanother person deal with the larger issue that resulted in the mistake.
7. “I will ensure love is always a verb.”
You love your work. When you’re working, that feeling shows in everything you say and do.You love your family. When you’re with them, does that feeling show in everything you say and do?
Hmm.
Love is a feeling, and feelings are often selfish. Turn your feelings into an action. Actively love the people you love. Show them you love them by words and deeds.When you make love a verb, the people you care about know exactly how you feel.
8. “I will be myself.”
You worry about what other people think. Yet no matter how hard you try, you can’t be all things to all people.But you can be as many things as possible to the people you love. And you can be the bestyou. So above all, always yourself. That’s the one thing you can always do better than anyone else.
How you can admit to crimes you didn’t commit?
In a surprising new study, researchers in Canada and Britain have shown how easily completely innocent people can be guided not only into thinking they committed crimes in their youth, but also in creating detailed memories of those crimes.Stephen Porter PhD is co-author and guided the study. He is a professor of psychology at the University of British Columbia, a registered forensic psychologist and Director of the Centre for the Advancement of Psychological Science & Law (CAPSL).Read and listen to the story from RCI.
Global oncology spending reached $100 billion in 2014
new report finds that early cancer diagnosis, treatment duration and effectiveness of therapies have improved alongside increased levels of spending on cancer drugs. The global spending on oncology medicines broke the $100 billion threshold in 2014, the IMS report.
“The increased prevalence of most cancers, earlier treatment initiation, new medicines and improved outcomes are all contributing to the greater demand for oncology therapeutics around the world,” says Murray Aitken, IMS Health senior vice president and executive director of the IMS Institute for Healthcare Informatics, who produced the new report.
One of the report’s key findings is that the cost of the global oncology market reached $100 billion in 2014 – an increase of $75 billion from 2009.
However, within the US, there has only been a modest increase of spending compared with the five largest European countries. Between 2010 and 2014, oncology grew from 13.3% of total drug spending to 14.7% in these European countries, compared with a rise from 10.7% of total drug spending to 11.3% in the US during the same period.
Another main finding is that clinical outcomes are improving for all major cancers. According to the report, 5-year survival rates have risen thanks to continuous improvements in detection and treatment. Two thirds of Americans diagnosed with cancer live for at least 5 years nowadays, compared with just over half in 1990.
The report predicts that these increases in survival will increase substantially thanks to new developments in “immuno-oncologic” and combination treatments, and suggests that biomarker-driven drugs and diagnostics will have a transformative effect on oncology.
“Innovative therapeutic classes, combination therapies and the use of biomarkers will change the landscape over the next several years,” Aitken says, “holding out the promise of substantial improvements in survival with lower toxicity for cancer patients.”
Access to new cancer drugs varies between nations
The report found that patient access to cancer drugs varies wildly across all markets, however. In 2014, patients in Japan, Spain and South Korea had access to fewer than half of the new cancer drugs launched globally in the past 5 years. Even in the wealthiest countries, drugs that are not reimbursed will only reach a tiny proportion of patients.
In the US, average treatment costs per month have increased 39% over the past 10 years. In the same period there has also been improvements in patient response (up 42%) and treatment duration (increase of 45%), which the report states reflect improved survival rates.
The report also observes that the costs of intravenous cancer drugs in the US rocketed up by 71% during 2012-13 as a result of increased outpatient facility costs.
Finally, the IMS reveal that discussion boards, followed by Twitter, have become the most dominant channels that patients use to engage with a variety of topics – from treatment options to financial concerns – during their cancer journey. The researchers assessed 6 months of social media discussions related to prostate cancer and found that the most frequently discussed topic was treatment options, followed by financial concerns.
A recent analysis published in Blood, the Journal of the American Society of Hematology, found that new, expensive blood cancer drugs – which can cost up to $100,000 per year – deliver high-value treatment.
“Given the increased discussion about the high cost of these treatments, we were somewhat surprised to discover that their cost-effectiveness ratios were lower than expected,” admitted senior author of that study, Peter S. Neumann, director of the Center for Evaluation of Value and Risk in Health at Tufts Medical Center in Boston, MA.
“Our analysis had a small sample size and included both industry- and non-industry-funded studies. In addition, cost-effectiveness ratios may have changed over time as associated costs or benefits have changed. However,” Neumann concluded, “the study underscores that debates in health care should consider the value of breakthrough drugs and not just costs.”
Linked publications from a single trial: a thread of evidence
Introduction
Trials was launched with the ambition of providing authors with the opportunity to provide all the necessary detail for a true and complete scientific record. It has long pushed for the communication of all outcome measures in health-related randomized controlled trials, as well as varying analyses and interpretations, and in-depth descriptions of what was done and what was learnt. An integral part of this was, of course, the publication of study protocols, which had rarely been possible in paper-based journals . A published protocol establishes precedence, allows more detailed discussion of methodological issues and can be referenced when reporting the main trial results .
The increasing publication of study protocols is undoubtedly one of Trials’ greatest successes . However, despite recent movements towards greater transparency in reporting research, concerns remain regarding the widespread discrepancies between trial publications and what was stated in the original study protocol . Indeed, there is strong evidence that selective outcome reporting, with manipulation of the outcomes and analyses reported, is a common problem in medical research . This serves to highlight the importance of researchers having access to all of the relevant information, to reliably evaluate bias or selective reporting in clinical trials.
However, while Trials regularly publishes the results of trials, primary trial reports are still predominantly published elsewhere. Although a results paper may reference a published study protocol, there is nothing to connect that report to subsequent publications; and no link from the protocol itself to the results article. This situation is further complicated by the ever-growing body of literature. A single clinical trial can result in multiple publications: the study protocol and traditional results paper or papers, as well as commentaries, secondary analyses and, eventually, systematic reviews, among others .
The advent of trial registration has helped to mitigate, to some extent, the lack of connectivity by providing a unique identifier associated with each trial record. However, while major medical journals typically capture the clinical trial number on or before publication, many do not followTrials’ example by publishing it in the abstract, as is recommended by CONSORT for Abstracts and the International Committee of Medical Journal Editors (ICMJE) . The reader thus has to identify related content through a literature search, using titles, authors and the abstract; details that will not necessarily remain consistent, as the articles may be published in different journals, with different authors, over many years.
Threaded publications
In 1999, Chalmers and Altman envisioned a solution. In their article in The Lancet, they wrote: ‘Electronic publication of a protocol could be simply the first element in a sequence of “threaded” electronic publications, which continues with reports of the resulting research (published in sufficient detail to meet some of the criticisms of less detailed reports published in print journals), followed by deposition of the complete data set’ . This was the first description of the threaded publications initiative.
Building on the concept of trial registration, the aim of the threaded publications initiative is to link all publications relating to a single clinical trial centrally, regardless of journal or publisher, using the clinical trial number. This means that no matter which article in the ‘thread’ researchers start from, they will be easily able to identify and gain access to all other publications relating to that clinical trial. In 2011, we began to put this linkage into practice within Trials; however, to achieve its fundamental aims, the project must go beyond a single journal or publisher.
It was in pursuit of this ambition that, in partnership with CrossRef, BioMed Central called a cross-publisher meeting to discuss how to build on the well-established digital-object identifier (DOI) and the more recent CrossMark tool, which provides information on the status of the associated article and an additional publication record, to achieve the threaded publications concept . The meeting spurred the formation of a working group to govern the development of the project. Chaired by BioMed Central, the working group includes representatives from CrossRef, BMJ,Canadian Medical Associate Journal, the Cochrane Collaboration, eLife, F1000, the Internal Standard Randomized Controlled Trial Number (ISRCTN) Registry, The Lancet, Origin Editorial, the Public Library of Science, Springer, The Wellcome Trust and Wiley, and is overseeing the development of the first phase in the threaded publications concept, Linked Reports of Clinical Trials.
Linked Reports of Clinical Trials
The Linked Reports of Clinical Trials project will adapt the existing CrossMark standard to capture additional metadata about an article, namely the clinical trial number, the trial registry and the relation to the primary trial report, and associate that information with the article DOI on publication. A query to this CrossRef database will then return all articles related to that clinical trial number. As all the metadata will be open access (CC0 license), with no copyright, it will be possible to access this article ‘thread’ either through the CrossMark interface or independently through an application programming interface (API).
A pilot evaluation of this system is set to begin towards the end of 2014, trialling how to adapt existing article workflows to capture these additional metadata prospectively and in an efficient and sustainable manner. For the initial pilot phase, only those articles for which the clinical trial number is currently required for publication by the publishers involved will be included; this includes study protocols and updates , statistical analysis plans , primary results papers and secondary analyses . Following successful implementation on this subset, the scope will be expanded to capture the clinical trial number for additional article types related to clinical trials, such as case reports of adverse events, commentaries and editorials.
Conclusion
The medical literature is vast and it is impossible to keep up with the deluge of new research articles. With ongoing concerns regarding manipulation of the outcomes and analyses reported in medical research, it is increasingly important that researchers are able to easily identify and access all publications relating to a specific clinical trial, in order to obtain the complete picture and to evaluate bias or selective reporting reliably. Recent developments and innovations within the threaded publications initiative and the Linked Reports of Clinical Trials project demonstrate progress towards the ideal of making all trial information readily available.
Abbreviations
CONSORT: Consolidated Standards of Reporting Trials; DOI: Digital-object identifier; ICMJE: International Committee of Medical Journal Editors; ISRCTN: Internal Standard Randomized Controlled Trial Number; API: Application programming interface.
Competing interests
DGA, CDF and JMG are Editors-in-Chief of Trials; DRS is an employee of BioMed Central Ltd, which publishes Trials.
Authors’ contributions
DRS wrote the first draft of the manuscript. DGA, CDF and JMG were involved in review and critical revision of the content before publication. All authors read and approved the final manuscript.
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Hi,I,m Basim from Canada I,m physician and I,m interested in clinical research feild and web development.you are more welcome in our professional website.all contact forwarded to basimibrahim772@yahoo.com.
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