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 […]
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 […]
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) […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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) […]
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 […]
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) […]
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. […]
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) […]
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) […]
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 […]
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 […]
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) […]
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. […]
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) […]
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 […]
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) […]
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) […]
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) […]
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) […]
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 […]
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 […]
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) […]
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 […]
