Safety/Efficacy Featured Articles
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Lessons Learned From The Rise And Fall Of Scios
4/7/2017
When Roger Mills began his career in the medical profession, he never imagined he would one day end up working for a Big Pharma company or find himself in the middle of a controversy over attempts to bring a new cardiology drug to market. That journey would see a small company teeter on the brink of bankruptcy, experience the highs of a new drug approval and acquisition by a large company, and finally, the downfall and collapse of the approved medicine.
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Clinical News Roundup: Biopharm Seeks More FDA Input On Endpoints
3/24/2017
Clinical News Roundup for the week of March 19, 2017 with information on FDA, NIH, clinical trial applications, pharma’s reputation, and an algorithm to make trials safer and less costly.
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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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How Will Changes At FDA Impact Clinical Trials?
3/20/2017
The 21st Century Cures Act has been approved by both the House and Senate, and late last year was signed into law by President Obama. The 996-page bill includes changes to the way FDA regulates drugs, medical devices, and biologics. In 2017, we have seen a change in administrations and will likely see a change in leadership at the FDA. I took this opportunity to touch base with David Rosen, co-chair of the life science practice at Foley & Lardner LLP and a law practice consultant. In this Q&A, Rosen shares his thoughts on the new legislation, changes coming to FDA, and why the patient perspective needs to remain a primary concern of the drug development industry.
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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.
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Clinical News Roundup: Women Significantly Benefit From OB/GYN Trials
3/3/2017
Clinical news roundup for the week of February 26 with information on women and OB/GYN trials, Sanofi partnering with Science 37, benefit explanations tied to increased recruitment, digital tools, and patient recruitment in rare disease trials.
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Are You Conducting Proper CRO Oversight?
3/2/2017
Are my CROs doing what I hired them to do? That is a question you may have asked yourself many times. Even if you have conducted a thorough CRO search and selected the one that best meets your needs, there is no guarantee it is performing the tasks most important to your clinical trial.
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FDA Reports On 2016 Diversity Results
2/28/2017
In a recent blog post, John Whyte, director of professional affairs and stakeholder engagement at CDER, notes until the late 1980s, clinical trials were conducted primarily on men. But a lot has changed over the last 30 years. We now know that some drugs affect men and women differently. This is why it is important for sponsors to test drugs on the appropriate patient populations, especially when developing “novel drugs.”
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Finding The Right CRO For Rare Disease Trials
2/27/2017
CRO selection is a challenge for every company outsourcing clinical trials. When the trial you are about to launch is for a rare genetic disease and has 30 patients spread across multiple countries and continents, the challenges are multiplied. This was the situation for Cerenis Therapeutics, which recently launched a Phase 3 trial for patients having very low levels of high-density lipoprotein.
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GSK Uses Apple ResearchKit In Rheumatoid Study
2/21/2017
As the chief medical officer at GSK, Murray Stewart spends most of his time focused on patients. A recent PARADE (Patient Rheumatoid Arthritis Data from the Real World) study, launched last year, was the first time GSK attempted to use Apple ResearchKit in a clinical study. Within 48 hours, the company had over 200 downloads, and was hopeful they would not just receive data from patients, but insightful information.