Applied Clinical Trials Blog

Monthly Archives: January 2010

Partnering in China, Asia-Pacific

—May Ling Chan, Voisin Consulting, corresponding for Applied Clinical Trials The Asia-Pacific region has many relatively untapped resources: it is home to one third of the world’s population, collectively the region’s economy is growing at a fast pace (particularly in China, Korea and India), and accordingly it has one of the fastest expanding pharmaceutical markets. Against this [...]
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Ding Dong, Avon’s Calling

It’s safe to say that Avon’s done a lot of things right during their 124 years. That they’ve been able to thrive for that long is testament to the fact. And now they’re achieving success in their next venture that’s proving a savvy, Internet-based recruitment model for research.  It’s called the Love/Avon Army of Women, or [...]
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PRO: Power to the People

On the heels of its announcement that Quintiles has chosen it to be its preferred provider for ePRO solutions, invivodata held a Webinar yesterday offering its take on the FDA’s final guidance in Patient Reported Outcomes (PRO).  Jean Paty, PhD, co-founder and Senior Vice President, Scientific, Quality and Regulatory Affairs at invivodata, said, “This is a [...]
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Put Your Money Where Your Molecules Are

Today, we’re linking to a blog from Erik Greb with our sister blog PharmTechTalk. Erik offers his opinion on biopharmaceutical innovation in the United States.
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Bias Can Undermine Statistical Tests

  The presence of bias error may reduce the power of statistical tests, and if bias error does exist, you must acknowledge it and be careful when drawing conclusions. That’s the take-home message of a poster presentation made at the Radiological Society of North America meeting, held in Chicago early last month. The authors, Drs. Gobert Lee and [...]
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Flat or Fallen Growth for Research

While the information contained in a study published in JAMA yesterday is not something we haven’t heard before, it merits attention because it’s located in one collected place and, well, it’s JAMA. The study authors declare that NIH funding is down; NME approvals are down; pharma budgets are larger for late-stage trials vs. drug discovery [...]
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Writing Proposals: The Competing Goals of CROs and Sponsors

A recent CBI conference, Contracting for CROs, brought to the surface lingering issues that exist in the CRO–Sponsor relationship—particularly those pertaining to the proposal process. While sponsors want to view proposals in a standardized manner and CROs want to seize the opportunity to break the mold, there simply is not enough room for both. Ravin Warnakulasuriya, Vice [...]
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China on Their Minds

It’s no secret that in recent years China has been attracting drug companies to its shores. After all, it’s an emerging market. What one might call “hot.” And in the past few months it seems a week doesn’t go by without a story on one of the major pharmaceutical companies and their activities in the [...]
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Dos and Don’ts of DMCs

When responsible for safety monitoring in a clinical trial, there are likely to be challenges faced, ethical issues, and grey areas.  Whether you yourself are a part of a data monitoring committee (DMC) or may one day do business with one, there are several key things to pay attention to. Potential Challenges Offering their advice on the [...]
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Five Golden Rules for the New Year

The arrival of a new year always provides a wonderful opportunity for a fresh start and a new beginning. Once the festivities and holidays are over, it’s an ideal time to re-evaluate your personal and professional lives, as well as setting new goals and priorities for the year ahead. We asked Dr. Johanna Schenk, one of [...]
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