Pulse: Industry Perspectives

The importance of the monitoring visit report

Monday, July 18, 2016

The Pulse on Study Conduct by Elizabeth Weeks-Rowe

The monitoring visit report serves a spectrum of integral purposes specific to each monitoring visit type. It is the medium by which all findings identified at monitoring visits, and the status of findings from previous monitoring visits, are documented. It provides conceptual proof of training delivery for initiation visit conduct, and a logistical, clinical and developmental summary recommendation of the investigational site following the pre-study assessment. The closeout visit report signifies closure of investigational sites with submission and signature. The monitoring visit report is the full confirmation of monitoring processes at investigational sites.

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Patient-centricity v. patient recruitment: One in the same?

Monday, July 11, 2016

The Pulse on Site Success by Christophe Berthoux

It is no surprise that delays in clinical trial timelines can largely be attributed to issues with patient recruitment and retention. Research has shown that nine out of 10 clinical trials eventually meet their enrollment goals; however, reaching these goals usually increases timelines by double what was originally intended. A 2013 study from the Tufts Center for the Study of Drug Development found that most sponsors and CROs rely on a limited number of traditional recruitment methods and have yet to embrace newer, non-traditional strategies, such as social media campaigns.

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The issue of patient retention in clinical trials

Monday, June 27, 2016

The Pulse on Patient Recruitment by Ashley Tointon

Recent discussions in the clinical trials arena among patient recruitment professionals have centered around accurately defining and understanding the difference between patient retention and patient adherence. Although both are important to the success of a trial, they may fall in distinct work streams that can easily be confused. 

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Don’t be hasty in clinical research decisions

Monday, June 20, 2016

The Pulse on Study Conduct by Elizabeth Weeks-Rowe

The ability to use good judgment and make sound decisions in clinical research is based on experience, communication and execution. Decision making is influenced by such factors as the familiarization with regulations that govern clinical research, successful management of investigational site relationships and corrective and preventative action with issues that affect patient safety and credible data (informed consent, protocol deviations, safety reporting).

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A key to site success is a patient-centered approach

Monday, June 13, 2016

The Pulse on Site Success by Christophe Berthoux

Our industry is inundated with new buzz words and concepts related to innovation, site centricity, patient centricity, patient affairs and patient engagement. It is commonplace to see new job titles and functions created to develop operational processes around these concepts. As clinical research sites, we have focused on understanding the patients we serve face-to-face every day. While the concept of patient centricity may once have been called “patient recruitment” or “patient retention,” these terms include the same elements as those found in the phrase “patient as a participant” emphasized today.

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Marginalization of millennials: Changing the clinical research landscape

Monday, June 6, 2016

The Pulse on Global Trials by Matthew Howes

Millennials, those born between 1980 and 2000, are the subjects of an inVentiv study conducted earlier this year. The report, Millennial Mindset: The Collaborative Clinician, explores the changing expectations of clinicians and how they prefer a collaborative approach to nearly all aspects of their practice.

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Diverse populations—and transparent data—necessary for recruitment

Tuesday, May 31, 2016

The Pulse on Patient Recruitment by Ashley Tointon

Medicines affect various populations differently, so it is essential to have a diverse population when recruiting for clinical trials. Although specific patient recruitment tactics can be successfully deployed to reach certain sub-groups, there is a pervasive population disproportion in clinical trial participants. Such an understanding is the initial step to conquering the problem of minority recruitment. Once the gap is identified, the next and most difficult step is to implement actions designed to close the gap. 

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The power of mentoring in the CRA career

Monday, May 23, 2016

The Pulse on Study Conduct by Elizabeth Weeks-Rowe

Achieving a full circle career experience in clinical research is powerful. Error and accomplishment contribute to a full developmental process, and they demonstrate stepping beyond personal fears to achieve lifetime goals and hit that proverbial stride. My experience is proof of the positive influence that targeted mentoring can have on a fledgling career.

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Can clinical trials be reinvented?

Monday, May 16, 2016

The Pulse on Site Success by Christophe Berthoux

Over the last few years, I have been involved in several initiatives related to strengthening the sustainability and reducing the burden of sites around the globe. This momentum is growing through associations working on behalf of sites such as the Alliance for Clinical Research Excellence and Safety (ACRES), the Association of Clinical Research Professionals (ACRP), the Society of Clinical Research Sites (SCRS), the Collaborative Institutional Training Initiative (CITI), TransCelerate and others.

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Clinical research and the Zika virus

Monday, May 9, 2016

The Pulse on Global Trials by Matthew Howes

Zika, the latest public health threat, has been hot media buzz for a while now. What began in early 2015 in Brazil has spread to neighboring parts of Latin America, as well as islands in the Pacific. In January 2016, the World Health Organization (WHO) said the virus was likely to spread throughout most of the Americas by the end of the year. Will public awareness and fear of the disease spreading translate into rapid action on the part of clinical research? Probably not.

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