Pulse: Industry Perspectives

The key to drug development success is collaboration

Monday, September 12, 2016

The Pulse on Study Conduct by Elizabeth Weeks-Rowe

Bridging drug discovery to drug development is a fundamental tenet in clinical research conduct that requires strategic collaboration. Successfully bridging investigational site relationship discovery to site development requires the same critical collaboration from study startup to study conclusion, and all pivotal points in between. The investigational site/study team dynamic will positively or negatively drive site performance in a clinical trial, and successful stewardship is key to this outcome.

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The CRO-site relationship: Gaining interest and momentum

Tuesday, September 6, 2016

The Pulse on Site Success by Christophe Berthoux

A great deal of emphasis has traditionally been placed on the sponsor-site relationship and the sponsor-CRO relationship; however, given the complexities of the current clinical research environment, these relationships are being redefined. CROs have recognized the importance of developing new approaches in order to ease the administrative burden typically placed on sites.  

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The many roles that contribute to patient recruitment

Monday, August 22, 2016

The Pulse on Patient Recruitment by Ashley Tointon

Recruiting patients into a clinical trial takes careful planning and flawless execution from multiple sources. Although the site is often responsible for contributing the majority of patients needed to meet enrollment targets, there is not one single person or role that is ultimately responsible for patient recruitment. Principal investigators, study coordinators, clinical research associates (CRAs), sponsors, CROs, feasibility analysts, patient recruitment specialists and consultants all play a role.

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The meaning of a 483: An opportunity for growth or label to be feared

Monday, August 8, 2016

The Pulse on Site Success by Christophe Berthoux

An FDA Form 483 may not be new, but it still brings fear of the unknown, regardless of tenure, to the clinical research industry. The implications of receiving a Form 483 are perhaps perceived differently by stakeholders, and some sites lack clarity regarding the purpose and anticipated results surrounding a Form 483.

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The hunt for an HIV vaccine

Monday, August 1, 2016

The Pulse on Global Trials by Matthew Howes

In the 1980s, HIV was a death sentence. Today, three decades later, clinical research has produced therapeutic breakthroughs that have turned HIV into a chronic yet manageable disease. Drugs that approach the disease from different angles, in combination with each other, are able to reduce viral load—the amount of virus in the body—to levels that are undetectable.

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Develop a patient recruitment strategy the right way

Monday, July 25, 2016

The Pulse on Patient Recruitment by Ashley Tointon

When recruiting patients for clinical trials, multiple things can go wrong. The majority of us have likely encountered at least one horror story involving huge patient recruitment budgets that resulted in miniscule measurable results. These pervasive stories enable the continuation of a commonly held feeling of skepticism about the value of patient recruitment services. The “when things go wrong” story is passé and should be replaced with the “when things go right” story. One of the best ways to ensure patient recruitment success is to set up the program correctly from the start.

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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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