Safety/Efficacy Featured Articles
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Fear And Mistrust Keep Patients From Trials
12/2/2016
African Americans constitute about 12 percent of the U.S. population, but represent just 5 percent of clinical trial participants. That figure is even worse for Hispanics, who constitute 16 percent of the population and represent only about 1 percent of trial participants. Are fear and mistrust keeping minorities from enrolling in clinical trials?
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How FDA Hopes To Get More Women In Clinical Trials
11/30/2016
Diversity is important in clinical trials, and one group that has been pushing for greater diversity is the FDA. The Office of Women’s Health in the FDA, established about 22 years ago, has been given the mission of advocating for the inclusion of women in clinical trials and analyzing data for the effects of gender. “The FDA has had to evolve,” says Marsha Henderson, assistant commissioner for women’s health at the FDA. “We have evolved with the science and with public expectations.”
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Helping Trump Prioritize His Clinical Trials Agenda
11/21/2016
Scrolling through my Facebook and Twitter feed in the days immediately following the presidential election, you would think the world had just ended. The next four years will certainly be a period of change. For many, change brings uncertainty and fear. But rather than speculate on what we may or may not see over the next four years, let’s focus on what we might hope to see, and what would be best for the industry.
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DrugDev Enters Patient Arena With SecureConsent Acquisition
11/18/2016
As an organization, clinical trial solution provider DrugDev has placed a focus on making the lives of site personnel easier. That mentality of servicing the site has primarily focused on interactions between sponsors and CROs and how those interactions can be improved. With its acquisition of SecureConsent, that focus now includes patients as well.
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Clinical News Roundup: ICH Looks To Revamp GCP Guidelines
11/18/2016
Clinical News Roundup for the week of November 14, 2016 with information on efforts of the ICH to revamp GCP guidelines, DrugDev’s acquisition of SecureConsent, and successful outcomes resulting from an adaptive trial approach.
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Clinical News Roundup: Artificial Intelligence Ready To Run Clinical Trials
11/11/2016
Clinical News Roundup for the week of November 7, 2016 with information on artificial intelligence running clinical trials, the UPS acquisition of Marken, efforts to track unpublished trial data, clinical success with the Zika virus, Takeda’s digital health efforts, and more.
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Lilly Makes It Easier For Physicians To Become Investigators
11/10/2016
As the global head of clinical innovation for Eli Lilly and Company, Katherine Vandebelt knows there are many things pharma needs to do better. No drug can make it to market without first navigating the clinical trials process, which creates a burden on the physicians involved. Therefore, it should come as no surprise to anyone involved in the process that many physicians will oversee one trial and then opt to no longer take part in them.
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Are Outdated Pricing Models Hurting Clinical Research?
11/8/2016
Two issues that always seem to throw a wrench into sponsor/CROs relationships are changes to staffing and pricing. Protocol changes can disrupt trials for CROs and cause price increases for sponsors. Staffing changes can create new learning curves, delay trials, and cause sponsors to feel they were misled. Are penalties an easy way to fix both?
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UPS Expands Clinical Life Science Opportunities With Marken Acquisition
11/7/2016
UPS has entered into a definitive purchase agreement to acquire Marken, a global, privately-held provider of supply chain solutions to the life sciences industry. The transaction, which provides UPS with growth opportunities across the life sciences customer base, is expected to close by December 31, 2016, subject to customary conditions and regulatory approvals.
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Clinical News Roundup: FDA Updates Guidance On Race/Ethnicity
11/3/2016
Clinical news roundup for the week of October 31, 2016 with information on FDA guidance related to race and ethnicity in clinical trials, DIA’s patient engagement study, Parkinson’s Disease Foundation funding research, age and thyroid cancer treatments, and Merck’s success with Alzheimer’s disease.