Action Items

The healthcare revolution: Innovation is out

Sunday, May 15, 2016

The healthcare transforma­tion, though not without its challenges, has made remarkable progress as of late. The industry is working at breakneck speed to avoid the default future that many of us expected just a few years ago. The term “innovation” has become somewhat of a cliché. In fact, inno­vation can really no longer even be applied to healthcare. It no longer fits. Innovation indicates making changes to something established, yet the very nature of healthcare today is change.

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Finding investigators and patients for faster trials

Friday, April 15, 2016

In the January issue of The CenterWatch Monthly, I wrote about using insurance claims and electronic health records (EHR) to understand patient availability for clinical trials. Combined, these sources can tell you if enough patients meet the criteria, enabling redesign and better planning.

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Refocusing on risk mitigation in starting clinical trials

Friday, April 1, 2016

While risk management efforts in drug development have focused mostly on post-marketing drug safety, the clinical trials process has its own mix of potential risks waiting to derail a company’s multimillion dollar development programs. These risks include patient enrollment issues, site staffing shortages, drug supply logistical problems, and regulatory delays. Risk-based challenges are escalating as clinical trials become more global and complex, and as market pressures keep rising for new therapies at an ever-increasing pace.

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High risk of ignoring individual patterns of medication adherence

Tuesday, March 15, 2016

Hundreds of millions of dollars are spent ensuring operational quality in clinical trials includ­ing site compliance, accuracy of data entry and enrollment targets. Meanwhile, one of the most vul­nerable aspects of the process—whether or not study participants are taking the investigation com­pound—receives surprisingly scant attention.

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A new class of best practices for clinical trial monitoring

Tuesday, March 1, 2016

Until recently, real-time study vis­ibility into milestone drivers such as enrollment, data quality and patient compliance was virtually im­possible to obtain. Spreadsheets have served their time as the go-to manual computation and compilation tool. With the growth in the number of clinical systems per trial, spreadsheets can no longer keep up with the data aggregation and insight needed to minimize risk and cost. The minute data is entered into a spreadsheet, it begins cooling.

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Understanding feasibility for faster clinical trials

Friday, January 1, 2016

Do you hate to be late? Most people do, but CenterWatch surveys of investigative sites show the majority have delays. A root cause is increasing eligibility cri­teria (up 58% in the last decade). It is no wonder that sites say recruit­ment is the biggest cause of delay; with more criteria, fewer patients qualify.

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