Clinical Operations Featured Articles
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Should We Rethink Randomized Clinical Trials?
8/1/2017
If we want to accelerate the drug development process, is it time to reconsider randomized clinical trials? That was the main question asked at a recent colloquium that included industry leaders from pharma networks, academia, patient groups, major medical centers, and the FDA.
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How Do Top Companies Audit Their CROs?
7/17/2017
How do top performing companies audit their CROs? When speaking to clinical executives, I found this to be one of their top concerns. At the inaugural Clinical Leader Forum, we brought together a panel of experts to discuss the topic.
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Bayer Uses Lessons From Past Trials To Beat Liver Cancer
6/23/2017
It has been approximately 10 years since Bayer’s medicine Nexavar was approved for the treatment of advanced hepatocellular (liver) cancer. Despite all of the research and money put into this effort since then, there has not been another drug approved for this disease. However, in April 2017, patients did finally see a new treatment (Stivarga) approved by FDA.
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Lupus Research Alliance Enhances Clinical Trials for Patients
6/16/2017
The Lupus Research Alliance is the largest non-profit health organization raising money for research into the cause, cure, treatment, and prevention of Lupus and its complications. The research programs funded are typically collaborations with hospitals, medical schools and universities, as well as pharmaceutical companies from around the world. While treatments are available, Farber notes they are far from perfect. This has led the Lupus Research Alliance to step up its efforts to improve clinical trials and get ned medicines to patients.
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SCRS Drives Site Payment Solutions
6/7/2017
Earlier this year, site payment issues were front and center at the European Site Solutions Summit that took place in Barcelona. The Summit, presented by the Society for Clinical Research Sites (SCRS), provides a forum for clinical stakeholders to discuss opportunities to improve clinical trials. In this Q&A, Dan Milam, VP of Global Engagement for SCRS, discusses the Summit, the issue of site payments, and what progress is being made.
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Site Payments Still A Global Problem
6/1/2017
Collecting payments has long been an issue for clinical sites, especially those without the financial resources to withstand payment terms of 90 to 120 days. At the SCRS Global Site Solutions summit last fall, I even heard site personnel state they will pay less attention to studies where the sponsor or CRO does not make payments in a timely manner. We know that 40 percent of sites have cited slow payments as a primary operating concern. Financial stress at sites may even be negatively impacting the success of clinical trials.
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Can A New Outsourcing Approach Improve Clinical Trials?
4/25/2017
For companies wanting to outsource their trials but also harbor concerns over CRO size and staffing, is there a solution? One group thinks they have come up with the answer. Four companies have come together to form a consortium designed to provide pharma with a dedicated team of trial experts focused on making studies more efficient and cost effective. Current members of the alliance include FMD K&L, inSeption Group, Pyxa Solutions, and OneSource Regulatory, with a plan to add more members in the future.
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Proposed Tax Change Would Impact Clinical Research
4/11/2017
Pharma companies that conduct clinical research inhouse essentially get a 100 percent tax break on the expenses incurred from that research (about 70 percent of which are normally wages). If they instead outsource that research to a CRO, they may claim only 65 percent of eligible expenses. The CRO gets no tax break, so that 35 percent difference simply disappears. If a group of congressmen get their way, that situation might soon change.
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AstraZeneca Strives For Greater Trial Transparency
3/22/2017
In February 2017, trial transparency provider TrialScope announced the launch of its Trial Results Summaries Portal that was developed in partnership with AstraZeneca. The Portal is a publicly accessible website where clinical trial sponsors can inform and educate trial participants and the general public about trial results in a non-promotional and non-biased venue.
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Open Source Data: Fact Or Fiction
3/3/2017
At the recent Data & Technology in Clinical Trials conference, I had the pleasure of listening to Aneesh Chopra speak. Chopra is the president of NavHealth and formerly served as assistant to President Barack Obama and Chief Technology Officer of the United States. His speech was electrifying, dynamic, and set the room abuzz.