Drug Safety/Pharmacovigilance Featured Articles
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Iroko Uses Event Monitoring System To Power Phase 3 Trial Of VIVLODEX
6/13/2016
In a recently completed Phase 3 trial, efficacy was demonstrated in patients with osteoarthritis pain who were treated with VIVLODEX, a low-dose SoluMatrix NSAID product. The Medication Event Monitoring System (MEMS) was used in the study to accurately track when patients required additional pain-relieving medication and to show that patients using VIVLODEX required less rescue pain medication.
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Genome Sequencing - The Key To The Cancer Moonshot?
6/10/2016
Though the announcement may seem recent, it was actually in October of last year when Vice President Biden boldly announced the “moonshot to cure cancer,” a personal passion fueled by his son’s death from the disease. Half a year later, this tall-order still has the industry – and world’s – attention, remaining the cause of consistent speculation and debate.
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Are You Familiar With The Framework For First-In-Human Testing?
6/7/2016
Although first-in-human dosing is a critical event in the clinical development pathway, Roger Mills believes few clinical trial personnel are familiar with either the theoretical or practical aspects of early human studies. A paper written by Jonathan Kimmelman titled “A Theoretical Framework for Early Human Studies: Uncertainty, Intervention Ensembles, and Boundaries” lays out some of those aspects.
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IN CASE YOU MISSED IT: Clinical Leader Top 3 Articles For May 2016
6/5/2016
Below are my top three articles downloaded on Clinical Leader for the month of May 2016. In case you missed them, please take this opportunity to see what everyone else was learning about Merck’s efforts to be a sponsor of choice, FDAs decision on Eteplirsen, and BMS’ success in clinical trials for Opdivo.
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ASCO To Take A Closer Look At Patient-Reported Outcomes In Clinical Trials And Cancer Care
6/2/2016
While the annual meetings of the American Society of Clinical Oncology (ASCO) can almost always be counted on to generate news about scientific breakthroughs in understanding and treating cancer, the theme for this year’s conference goes beyond that conventional approach. ASCO 2016 Annual Meeting will prominently feature discussions about how clinicians can best integrate recent advances, and particularly how to best assess the impact on real-world patients.
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France Tragedy Update: Bial & Biotrial At Fault; EMA Reviews Guidelines
6/1/2016
After the clinical tragedy in France in January, the French Health Ministry has found blame with the two companies involved in the trial, noting Bial and Biotrial were at fault on several counts. The EU has guidelines in place to ensure that does not happen again.
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BMS’ Opdivo Trials: What They Teach Us About Successful Studies
5/17/2016
It’s hard to ignore the news around immunotherapies to treat cancer. Opdivo is a Bristol-Myers Squibb (BMS) medicine that has been approved by the FDA for patients with previously treated advanced non-small cell lung cancer (NSCLC), metastatic melanoma, and renal cell carcinoma. Opdivo also provides a textbook lesson for sponsor companies on how to conduct a successful clinical trial.
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Clinical News Roundup: Industry Seeks FDA Guidance On mHealth Technologies
5/13/2016
Clinical Leader news roundup for the week of May 8, 2016, with articles on FDA guidance regarding mHealth technologies, Bitcoin improving transparency in trials, software to change the future of drug discovery, the growing use of wearables and social media in trials, and more.
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Will Disruptive Innovations Enhance Patient Outcomes?
4/29/2016
Disruptive innovation is a hot topic in clinical trials. So is patient centricity. While some innovations will help sponsors more effectively manage the drug development process, some are also poised to have a significant impact on patients taking part in studies. In this Q&A article, Melva Covington of Sanofi and Ross Weaver of Clinical SCORE discuss innovation, FDA mandates, and industry efforts to get patients more involved in clinical trials.
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Clinical News Roundup: FDA Rejects Evidence For Muscular Dystrophy Drug
4/28/2016
Clinical Leader news roundup for the week of April 25, 2016, with articles on the FDA rejecting a Duchenne muscular dystrophy treatment, Lilly, Merck, and Pfizer sharing patient recruitment success stories, machines making clinical trials more successful, using cannabis to treat epilepsy, metaform prolonging the effects of old age, and more.