Pulse: Industry Perspectives

Paying attention to rare disease markets

Tuesday, September 5, 2017

The Pulse on Global Trials by Matthew Howes

The market opportunity of rare diseases is tremendous. Experts predict global sales of drugs with orphan designations will reach $176 billion by 2020. Biopharma as an industry is collectively investigating some 450 different orphan drugs, demonstrating the strategic value inherent in the category. But with over 6,000 rare diseases affecting an estimated 350 million people around the world, they have only just begun to tap the full market potential.

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A critical need for timely site payments

Monday, August 28, 2017

The Pulse on Site Success by Christophe Berthoux

Research sites across the globe likely have felt the effects of delayed payments, inconsistent payment amounts and lack of explanation regarding what the payment was for. In a 2016 survey of Investigators conducted by DrugDev, getting paid “on time” was one of the top two burdens reported by sites. Receiving untimely payments not only produces financial stress to the site, it often leads to additional administrative load placed on staff members who must allocate resources to track down payments and deal with discrepancies.

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Key tips to give a strong study presentation

Monday, August 21, 2017

The Pulse on Study Conduct by Elizabeth Weeks-Rowe

Presenting information is an essential part of clinical research and is interwoven into every element of study conduct, from the key opinion leader revealing pivotal trial results at a large investigator meeting to the CRA presenting protocol information to investigational site staff during an initiation visit.

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Evidence-based site selection and study planning

Monday, August 14, 2017

The Pulse on Technology by Elisa Cascade

Any sponsor, CRO or third-party involved in site selection and study planning will tell you that data driven tools are the key to success. Thankfully, sponsors have a range of tools to choose from in today’s market that offer tables, charts, graphs, heatmaps, projections, scoring and in-depth reporting. The most important difference between these tools, however, is not the user interface, but rather the underlying data sources. So for sponsors, the question remains, “Are the tools responsible for successful study planning and site selection? Or should we worry about the data that feeds them instead?”

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Upfront planning crucial to process improvements and quality in clinical trials

Monday, August 7, 2017

The Pulse on Study Startup by Craig Morgan

If you fail to plan, you are planning to fail. These words ring true when it comes to study startup (SSU), especially as the clinical trials sector embraces planning as key to boosting study quality. With research showing a continually stagnating timeframe for conducting clinical trials and a trend toward overhauling study performance, quality improvement is moving to center stage. With the availability of workflow-based SSU tools (Figure 1), proactive planning, process optimization and quality improvements—as measured by audit-readiness and the likelihood of passing regulatory audits—are within reach.

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The call for patient feedback

Monday, July 31, 2017

The Pulse on Patient Recruitment by Ashley Tointon

Having a patient-centered approach is a positive trend in sponsored clinical trials as more companies reach out to seek input from patients. Pa­tient feedback can assist protocol developers in the creation of clinical trials that are more appealing to study volunteers. The input that patients are providing may be just as expected or it may be completely surpris­ing, yet incorporating the feedback into a fully developed strategy or protocol is not an easy task.

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Attractiveness of conducting clinical trials outside the U.S.

Monday, July 24, 2017

The Pulse on Global Trials by Matthew Howes

In the last decade, the pharmaceutical industry has been expanding clinical research outside familiar territories like the U.S. and EU. Countries like Australia, China, India and Russia have become hot locations for pharma companies to conduct their research activities, and it’s no wonder why. The benefits to expanding clinical research to more countries around the globe are clear. Trials can be completed six to seven months sooner, on average, in countries like China or India, and at a fraction of the cost compared to domestic markets.

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Opportunities to create a collaborative patient/professional relationship

Monday, July 17, 2017

The Pulse on Site Success by Christophe Berthoux

Increasing participation in clinical trials has long been a topic of discussion in the industry, and obstacles related to regulatory concerns, culture and communication are known to hinder outreach to the patient community. Fortunately, the focus on meaningful engagement has led to new ideas and opportunities to create dialogue between patients and professionals.

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Driving critical tenets of research

Monday, July 10, 2017

The Pulse on Study Conduct by Elizabeth Weeks-Rowe

Quality in clinical trials conduct is much more than a targeted goal to achieve. It drives the critical tenets of clinical research—patient safety, data reporting and statistical analysis. Quality should not be assigned a timeline, but should be considered a status to which we aspire daily. It should not be reserved solely for what is critical, but applied to seemingly mundane activities most often underestimated for impact.

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Vive le Mobile Revolution! But are clinical trial sites ready?

Wednesday, July 5, 2017

The Pulse on Technology by Elisa Cascade

In the past, the pharmaceutical industry has been reluctant to jettison old-fashioned methods in favor of new technologies. This has bolstered the industry’s critics, who argue that the old methods are to blame for the growing costs and timeframes of clinical development. However, this has begun to change over the past five years due to several factors, including regulatory authorities’ willingness to consider new approaches to clinical trial operations. As a result, technology is now being introduced into the industry at a rapid rate, with a high degree of trial use, but lower overall adoption1.

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