Pulse: Industry Perspectives

Compassionate use and the impact on clinical research

Monday, April 11, 2016

The Pulse on Global Trials by Matthew Howes

Requests for compassionate use of drugs not yet approved by the FDA have been making headlines, and experts predict this trend will continue. Last year, the FDA received 1,262 expanded access requests from drug companies, on behalf of patients, to use unapproved drugs outside of clinical trial programs.

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Getting the most from a central advertising campaign

Monday, April 4, 2016

The Pulse on Patient Recruitment by Ashley Tointon

There are few Patient Recruitment and Retention (PRR) tactics that are more controversial than the central advertising campaign. Although central advertising can cover several different mediums such as television, print, radio and online, most users fall into one of two groups: the “it worked” group or the “it didn’t work” group. This dichotomy is pronounced regardless of factors unique to each clinical trial, and hamper efforts to broaden the use of advertising for clinical trials. There are many factors that drive these strong opinions, including cost, the communication of expectations and the accountability of the study sites.

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Standing out and succeeding as a new CRA

Monday, March 28, 2016

The Pulse on Study Conduct by Elizabeth Weeks-Rowe

The young woman who stepped into the aisle had an earnest vibrancy about her. She was engaged in a lively phone conversation that continued even while she arranged luggage in the overhead bin and took her seat next to me. Boarding an airplane was secondary to her exciting conversation. From what I could gather, she and some colleagues had resolved a major issue during their business trip. She had performed well and received special recognition from her employer.

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Keep your eye on site industry innovation, focus on growth

Monday, March 21, 2016

The Pulse on Site Success by Christophe Berthoux

Dr. Jeffrey Adelglass

I am pleased to have the opportunity this month to thank CenterWatch and our readers for the opportunity to share my views on the exciting changes in the site community over the last two and a half years. It is with great pleasure that I transition the Pulse column to Christophe Berthoux, CEO of the global site management organization, Synexus, as a contributing writer. [Read More]

Logistics issues in clinical trials

Monday, March 14, 2016

The Pulse on Global Trials by Matthew Howes

Most industry experts estimate that supply chain logistics for clinical trials account for 20 to 25% of total R&D costs. There is evidence that those estimates are growing. EvaluatePharma reports that logistics services are experiencing a growth rate of 12%, which is faster than the more stable overall market growth of 2 to 2.5%. With rising cost pressures from payers and policy makers worldwide, it is surprising that more attention has not been paid to this increasingly dominant factor in clinical development.

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Making the most of media outreach

Monday, March 7, 2016

The Pulse on Patient Recruitment by Ashley Tointon

Due to the proliferation of clinical research studies and shortened timelines for recruitment, more studies depend on outreach activities to fill the gap between the number of participants needed in a research study and the number of participants a site can recruit within their own network. Media outreach is a ubiquitous tactic occasionally deployed to fill this gap, but it is often met with mixed results. 

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Effectively presenting critical study endpoints in an abbreviated timeframe

Monday, February 29, 2016

The Pulse on Study Conduct by Elizabeth Weeks-Rowe

A response to any message must be carefully crafted, considered and reconsidered before being sent, as we all know. One cannot reach into cyberspace and easily recall a transmission. Once the message is received, words therein are part of the proverbial audit trail critical to research documentation. This is why I hovered indecisively over my keyboard after reading a frustrating email from a co-worker that signaled an impending issue.

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Creating your personal secret sauce for site success

Monday, February 22, 2016

The Pulse on Site Success by Jeffrey Adelglass

We have a particular client that likes to refer to our enrollment successes as our “secret sauce.” They frequently ask us, “What makes you tick? What motivates your site to achieve enrollment targets both on time and early in some cases?” My response is that the secret sauce recipe includes the internal motivation and characteristics that drive the site team to meet these challenges, but must be stirred well with characteristics of the CRO and Sponsor that encourage site involvement.

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Patient recruitment and retention tactics vary

Monday, February 8, 2016

The Pulse on Patient Recruitment by Ashley Tointon

Patient recruitment and retention tactics vary as much as the protocols they support. While the primary focus is on the recruitment of individuals into clinical trials, sometimes it’s difficult to keep people in a clinical research study after they have signed up. Understanding why people drop out, when they typically drop out and uncovering the root cause is the basis for many retention strategies. 

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The CRA life: Dedication, passion, adaptability

Monday, February 1, 2016

The Pulse on Study Conduct by Elizabeth Weeks-Rowe

To achieve a level of expertise in a clinical research role, dedication that exceeds standard performance is required. It requires a passion for innovation, the willingness to work outside your position or comfort zone, and the ability to adapt what you’ve learned to align with regulatory standards. 

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