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Big Clinical Trials Falling to the Wayside in Era of Personalized Medicine

Big clinical trials may be falling to the wayside in light of a new era in health care, according to a recent Wall Street Journal report. Personalized medicine, in which a patient's care can essentially be customized based on genetic makeup, has signaled a shift in medical research. Click here for […]

more info 06/04/2018View Related Articles
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Follow-up Studies are MIA for FDA Approved Drugs

A recent study was conducted, examining drugs approved by the Food and Drug Administration (FDA) between 2005 and 2012 on the basis of a single pivotal trial. Researchers sifted through medical literature searching for follow-up, or post-approval studies - this is what they found. Subscription […]

more info 05/10/2017View Related Articles
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Observational Studies Fill a Void Left by RCTs

Real world evidence has received a reputation for sounding better than it performs - especially when compared to randomized trials. However, new data sources, study designs, and analytics are giving RWE new credibility. Read more here on page 24. (Source: Thomas Reinke, Managed Care pg 24, 1/2017) […]

more info 01/20/2017View Related Articles
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Medical Studies Omitting Info on Adverse Outcomes

A new analysis conducted by a team of British researchers, estimates approximately half of published medial studies on new treatments are leaving out information on adverse effects. The researchers analyzed 28 journal articles and cross-checked that data with more than 500 clinical studies. With out […]

more info 01/03/2017View Related Articles
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Big Data Survey Report

SCORR Marketing and Applied Clinical Trials recently released their survey report on big data and its impact on drug development services. The report also includes information on who supplies big data to the industry, database network participation, concerns and stakeholder utilization and […]

more info 12/19/2016View Related Articles
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O’Neill as FDA Commissioner = Rx for Bad Health

One of the people President-Elect Donald Trump is currently considering, for the Food and Drug Administration (FDA) Commissioner, Jim O'Neill, is neither a scientist or a physician, as were the majority of past commissioners of the FDA. Instead, O'Neill, a former policy adviser at the Department of […]

more info 12/13/2016View Related Articles
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ISPOR Webinar: How to be Pragmatic About Pragmatic Trials

Join ISPOR's complimentary informational webinar on Tuesday, December 13, 2016 between 3-4 PM ET (20:00 GMT), where expert presenters address the following questions and issues:Why pragmatic clinical trials (PCTs) are becoming increasingly important When they should be utilizedWhat can be learned […]

more info 12/08/2016View Related Articles
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What is so Controversial About RWE?

The U.S. House of Representatives has overwhelmingly passed the 21st Century Cures Act, moving it on to the Senate for approval. A very important and controversial piece of this legislation includes the use of real world evidence in the approval process. Patient advocacy groups say this will help […]

more info 12/02/2016View Related Articles
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Unpublished Clinical Trial Results – What You Don’t Know Won’t Hurt You

According to a new online tool, nearly half of all clinical trials conducted by big drug manufacturers during the last decade have not been published, but it doesn't stop there. An investigation by STAT found than many universities and medical centers have also been violating federal law by failing […]

more info 11/08/2016View Related Articles
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Patient Risk Preference to be Used in Clinical Trial Design

A recent project collaboration between RTI Health Solutions, the Medical Device Innovation Consortium (MDIC) and the Michael J. Fox Foundation for Parkinson's Research (MJFF) represents the first time patient preferences on benefits and risks have been used as an explicit means to set significance […]

more info 10/25/2016View Related Articles
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80% of China’s Clinical Trial Data Fraudulent!

A recent investigation of 1622 new drugs submitted to China's State Food and Drug Administration (CFDA) has found that 1308 of those applications should be withdrawn for containing fabricated, flawed, or inadequate data from clinical trials. Find out more here. (Source: thebmj, October 2016) […]

more info 10/20/2016View Related Articles
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Biden Announces Changes in Cancer Moonshot Clinical Trials

Cancer researchers welcome new changes to the 'Cancer Moonshot' initiative, recently announced by the U.S. Vice President, Joseph Biden. The new measures aim to help cancer patients navigate the clinical trials process allowing them to find clinical trials more easily and quickly and increase […]

more info 09/20/2016View Related Articles
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Nearly Half of All Clinical Trials Involving Kids Go Unpublished – Why?

New research suggests nearly half of all clinical trials involving kids go unfinished or unpublished. Why would companies not publish results? Why would researchers stop short of the finish line? Learn more here. (Source: Ivan Oransky and Adam Marcus, STAT, 8/19/16) […]

more info 08/22/2016View Related Articles
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OPDIVO Highlights the Importance of Comparative Efficacy

OPDIVO, a Bristol-Myers Squibb's immunotherapy drug, recently failed to demonstrate a clinical improvement compared to chemotherapy in patients with newly-diagnosed lung cancer. This led to a dramatic drop in the company's stock and emphasized the growing importance of comparative efficacy research. […]

more info 08/19/2016View Related Articles
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ERT Named Finalist in Technology Award

The Massachusetts Technology Leadership Council recently named Insights Cloud a finalist for the Innovative Healthcare Technology of the Year award. Learn more about Insights Cloud and this award here. (Source: ERT, 2016) […]

more info 08/05/2016View Related Articles
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Technology – Helping Match Patients to Clinical Trials

A number of new companies are now helping providers match patients to clinical trials using technology. Froedtert and the Medical College of Wisconsin recently announced a partnership with IBM doing just this. Find out more here. (Source: Beth Kutscher, Modern Healthcare, 6/6/16) […]

more info 06/07/2016View Related Articles
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Are Formulary Decision Makers Data Needs Being Met for Specialty Drugs?

This study targeted pharmacists and physicians involved with formulary decision making in order to assess the level of satisfaction of specialty drug formulary decision makers with regards to the strength of current available data sources and unmet needs regarding clinical, economic, and unpublished […]

more info 04/12/2016View Related Articles
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PCSK9 Inhibitors – Does the Benefit Outweigh the Cost?

The results of the GAUSS-3 trial were recently presented at the American College of Cardiology 65th Scientific Session & Expo and were published online in the Journal of the American Medical Association. How did the PCSK9 inhibitor perform among patients with statin intolerance? Was it found to […]

more info 04/05/2016View Related Articles
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Data & Technology in Clinical Trials – A State of the Industry Report

Eli Lilly, DrugDev Advisory Board and eyeforpharma conducted a State of the Industry' survey to investigate how pharma is currently leveraging data and technology and how this will change over the next 2 years? Download your copy today, here. (Source: eyeforpharma) […]

more info 03/08/2016View Related Articles
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When do You Start Your Pipeline Research?

Don't miss, "Accessing Pre-Approval Product Information - Making the Most of Your Pipeline Research" on Feb 17, 2016. This AMCP webinar will examine the elements of pipeline research and best practices for health care decision makers. […]

more info 02/11/2016View Related Articles
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Will Redefining Health Economics Contribute to Better Healthcare Systems?

Download Martin A. Morgenstern's '"Redefining Health Economics: How it Can Contribute to Better Healthcare Systems?" here. (Source: SSRN, 2/8/16) […]

more info 02/11/2016View Related Articles
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RWE – You’re Only as Good as Your Data

As healthcare continues shifting from volume to value the common saying, "you're only as good as your data" couldn't be more relevant. Take a look at the new ways Astellas is bringing better value to customers and patients - with real-world evidence as a key component, here. (Source: Dr. Jeffrey […]

more info 02/11/2016View Related Articles
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ERT Unlocks Innovation Through Collaboration

ERT's new Innovation Lab is intended to bring companies, big and small, together to collect data for clinical trials in a more streamlined way. Read more about why this is such a big deal here. (Source: Jessica Bartlett, Boston Business Journal, 2/5/16) […]

more info 02/09/2016View Related Articles
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How Important is Health Economic Modeling in a HTA Submission?

One area of a HTA submission that has always been incredibly technical is the Health Economic modeling, but how important is it? Read more here. (Source: Samad Azad, 1/29/16) […]

more info 02/07/2016View Related Articles
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5 Things You Should do with EQ-5D Data?

EQ-5D is the most widely used measure of patient reported outcomes (PROs) around the world, but are often under-reported, and inadequately analyzed. For anyone collecting or reporting EQ-5D data, here are some recommendations. Read more. (Source: Nancy Devlin, Office of Health Economics, 1/29/16) […]

more info 02/02/2016View Related Articles
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Top Journal Editors, Transparency Resistance, and Outcomes Switching

The New England Journal of Medicine and the Annals of Internal Medicine, have recently come under fire for their conflicted interests and resistance to transparency which is contributing greatly to the contamination and mistrust of medical literature. Read more. (Source: HealthNewsReview, 1/25/16) […]

more info 01/27/2016View Related Articles
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Do Observational Studies Exaggerate RT Benefits in Breast Cancer?

 “A meta-analysis of the randomized trials yielded a 15% to 20% reduction in the hazard for disease-specific mortality and about a 10% reduction in overall mortality for radiotherapy following breast-conserving surgery or mastectomy...In contrast, observational studies showed about a 35% reduction […]

more info 01/23/2016View Related Articles
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Download: Evidence 2016 Essential Payer Insights

Using real world evidence in clinical trials is critical to the success of patient recruitment and payer engagement programs. Through more stakeholder collaboration, we can help patients access the right treatment for them. How can we achieve this in practice? How do we overcome pricing and funding […]

more info 01/19/2016View Related Articles
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A Look at the New Economics of Today’s Drug Pricing

Leela Barham considers the impact of the many influences on medicines pricing today, ranging from government regulation to patient-group pressure. Read more here. (Source: Leela Barham, pharmaphorum, 1/8/16) […]

more info 01/11/2016View Related Articles
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How Can You Design More Effective Phase IV Studies?

Want to design and carry out more effective Phase IV trials studies? Learn from companies like Genentech and Sanofi about lean protocol design, opportunities for savings and considering the patient voice, in this FirstWord report, Harnessing the Power of Phase IV Observational Studies, now available […]

more info 12/08/2015View Related Articles
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