Pulse: Industry Perspectives

All for one and one for all: A call for a Three Musketeers approach to online profiles

Monday, May 22, 2017

The Pulse on Technology by Elisa Cascade

We all know there is an issue surrounding investigator participation in industry-sponsored clinical trials. Tufts University puts the figure for doctors declining to return for a second study at approximately 40%. At the same time, the number of global clinical trials continues to rise and increase in complexity. We’ve all read articles and attended conferences that expound the passionate view that investigators who commit their time and expertise need our help and encouragement. But if that’s the case, why do we as an industry fail to address the administrative burdens driving them away?

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The illusion of safety in study startup

Monday, May 15, 2017

The Pulse on Study Startup by Craig Morgan

Risk is our constant companion, and as clinical trials grow in complexity, so do risk-based challenges to bring new therapies to market at an ever-increasing pace. The continued reliance on Excel, which lacks project- and risk-management functionality, has created an illusion of safety often fueling the rescue study industry.

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Best and worst digital campaigns for patient recruitment

Monday, May 8, 2017

The Pulse on Patient Recruitment by Ashley Tointon

Recently, I was asked to discuss aspects of my best and worst digital campaigns for patient recruitment. Having completed so many digital campaigns, it is difficult to discern the best and worst, as they all had different parameters. Looking back retrospectively, distinct markers of good digital planning were determined primarily by two factors—strategy and execution.

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Patient advocacy in clinical research

Monday, May 1, 2017

The Pulse on Global Trials by Matthew Howes

Earlier this year, the FDA approved the first artificial pancreas for type 1 diabetes. The advancement is remarkable not just for the technology alone, but for how it came to be.

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Social media tips for research sites

Monday, April 24, 2017

The Pulse on Site Success by Christophe Berthoux

When sites are juggling multiple studies, it can be easy to push social media efforts to the backseat. However, this may deter from opportunities to expand clinical trial awareness and potentially bringing new business to sites. Fortunately, a site can implement tools and processes to allow for social media interaction, while maintaining the balance between keeping up with administrative workloads and providing patient care.

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Perfection’s role in a clinical researcher’s job performance

Monday, April 17, 2017

The Pulse on Study Conduct by Elizabeth Weeks-Rowe

The pursuit of, or expectation of, perfection in a clinical researcher’s job performance is a flawed ideology, rife with disappointment for anyone shouldering this impossible burden. As my father, R Stuart Weeks, M.D., used to say, “The pursuit of perfection prevents progress.”

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Free up sites to focus on patients, not payments!

Monday, April 10, 2017

The Pulse on Technology by Elisa Cascade

At a conference a few months ago, I spoke with a clinical trial investigator who complained that he still received paper checks in the mail from some sponsors and CROs, often with little or no information as to which protocol or trial procedure it referred to. It got me thinking. Why are we making this so hard for sites? Site personnel aren’t payments experts. They don’t want to spend time tracking down payments. They don’t have the technology expertise to care about how the payments are done. They just want their money deposited in their bank account on time, and with the associated documentation that explains what the payment is for. This is standard across other industries, so why should it be different for clinical trials?

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Why the cloud is pivotal to speeding clinical trials

Monday, April 3, 2017

The Pulse on Study Startup by Craig Morgan

Clinical trials are growing in complexity, complicated further by the convolution of demand, outsourcing and globalization. According to a recent study by KPMG, within the pharmaceutical industry the return on R&D expenditure has fallen from an industry average of approximately 20% in the late 1990s to just 10% today, while the average cost of developing a drug has risen during that period at a rate of 7.4% higher than inflation, due largely to the cost of conducting clinical trials. The drug discovery process is incredibly inefficient, complex, bureaucratic and, above all else, expensive—with only one out of every 10 drugs that start trials being approved by the FDA.

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The importance of providing education and awareness surrounding biosimilar products

Monday, March 13, 2017

The Pulse on Site Success by Christophe Berthoux

It has been seven years since the passing of the Biologics Price Competition and Innovation Act, a provision of the Affordable Care Act that created the approval pathway for biosimilars in the U.S. To date, four biosimilar products have been approved by the FDA, compared to 23 products in the European Union where biosimilars have been in play since 2007.

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