Introduction: Keeping Up - Pharmaceutical Executive

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Introduction: Keeping Up
While technology has grown in leaps and bounds, clinical-trials education has been left behind.


Successful Clinical Trials Management


Jeannette Park
Did you know that the first clinical trial was carried out between 605 and 562 B.C.? According to HealthandAge.com, King Nebuchadnezzar II ordered his subjects to follow a strict diet of meat and wine for three years. It wasn't until four children in his court convinced him to allow them to switch to bread and water instead that an endpoint was reached. After ten days, those in the bread-and-water group appeared resplendent—better nourished than those who had followed the meat and wine regimen.

Fast forward to the 21st century. The clinical-trials landscape has changed, to put it mildly. Instead of issuing royal decrees, pharma companies have compliance oversight procedures, policy guidelines, voluntary codes of conduct, and a host of rules. And with a scarcity of willing volunteers, pharma has to work harder to educate the public about ongoing clinical trials. In this competitive and fragile environment, individual drug companies aren't just keeping track of themselves—they're also keeping close track of their competitors.

A 2005 KMR Group study laid a foundation for companies to understand how well they perform relative to their peers as well as provide insight into those factors most influencing productivity. The study found that clinical-operations productivity is generally increasing within the industry, most recently at an annual rate of seven percent. Successful Clinical Trials Management takes a closer look at how fast the clinical-trials environment is changing, and what companies can do to keep up.

The KMR study found that sites in Asia are enrolling a greater number of patients per site than those in North America and Western Europe. The team at A.T. Kearney discusses how pharma companies are in fact taking advantage of offshore opportunities, but they argue that pharma uses incomplete data to choose the best country in which to conduct a trial. Their solution? Use data-driven analysis to better identify offshore clinical-trials opportunities.

Speaking of data, the study indicated that companies that rely on technology are more productive. William Claypool of Phoenix Data Systems sees this growing trend and discusses how the increasing use of electronic data capture (EDC) makes it easier to manage data and complete trials, particularly in complex disease areas like neurology and oncology.

David S. Zuckerman of Customized Improvement Strategies has similar sentiments when it comes to trial design. Making protocol easy enough to execute, he suggests, ensures a successful outcome.

Finally, Todd Betanzos, senior associate of Dallas-based Sedgwick, Detert, Moran, & Arnold, talks about the implications and outcomes for pharma companies when trial participants don't want a study to end.

If Nebuchadnezzar and his court had dreamed of even half the health concerns we have today, they would have known that it is impractical to subsist on meat and wine, or even bread and water. And instead of royal decrees, they might have tried a little education about risks and benefits to help them stimulate enrollment. In that sense, at least, not much has changed in clinical trials

Jeannette Park is Pharmaceutical Executive's special projects editor. She can be reached at

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