Pulse: Industry Perspectives

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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Rising demand for CRAs

Monday, June 26, 2017

The Pulse on Study Startup by Craig Morgan

Demand for Clinical Research Associates (CRAs), professionals whose main function is to monitor clinical trials, is expected to grow 1.52% annually by 2018, which results in many sponsors and CROs finding themselves in a never-ending recruitment cycle for qualified CRAs.

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Communicate, motivate and activate for successful patient recruitment

Monday, June 19, 2017

The Pulse on Patient Recruitment by Ashley Tointon

Recruiting patients for clinical trials is not as straightforward as it may seem. Identify­ing patients that match the inclusion and exclusion criteria can be an immense task on its own, yet it is not simply the identification that leads to successful enrollment. In order to collect optimal data, it is imperative to communicate, motivate and activate those patients who are willing to invest their time as participants.

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Publication bias and clinical trial outcomes reporting

Monday, June 12, 2017

The Pulse on Global Trials by Matthew Howes

Last month, the world’s leading funders of medical research and international non-governmental organizations agreed to set forth new standards that will require all clinical trials they fund or support to be registered, and the results disclosed publicly within mandatory timeframes. The aim is to dramatically improve both the quality of therapies available to patients, as well as the quality of research that leads to new breakthrough. But the question remains: Will it be enough?

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