More Trials & Tribulations for Clinical Monitoring

Clinical trial litigation is on the rise in the drug arena, and the effects could soon spread to the device industry. The Legal Times (Washington, DC) has reported that lawsuits are increasing and often pursue every person and institution in their paths. If device manufacturers want to avoid legal action, they need to protect themselves by making sure they’re not cutting corners.

The first step is to hire the proper staff to monitor clinical trials, says Steven Mayo, president of Austin, TX–based Emissary International, a contract research organization. "America seems to be in a lawsuit craze, and the number of high-profile lawsuits seems to be increasing," says Mayo. "The class-action lawsuit trend is a negative [development] that’s really affecting [the device] industry."

 

 
Mayo says inexperienced firms that don’t use CROs tend to make mistakes.

Lawsuits can be filed for everything from patient safety during clinical trials to adverse events after a product is approved. "There have been some high-profile mistakes made in the industry," says Mayo. "Those activities are going to raise questions in the public mind regarding device quality in the marketplace. Any time that’s brought into question, there’s a horde of lawyers ready to take advantage of any weakness."

Spending a little extra money to avoid that horde could save a company millions of dollars in future court costs. Mayo says that the device industry sometimes cuts corners by failing to use contract research organizations (CROs). CROs work with multiple clients and trials, and they can transfer their experience to other companies that are developing similar devices.

"When companies don’t use CROs, they try to train their own people in midtrial," says Mayo. "They lose the advantage of experience and tend to make mistakes. Those mistakes can be translated into poor-quality data and poor monitoring of activities. The data aren’t complete, accurate, or well-controlled."

Having a well-trained staff or using a qualified CRO is key when conducting a trial, according to Bill Morton, president of Medical Device Consultants Inc. (North Attleboro, MA). "There are also training courses offered by a number of organizations on how to properly manage and monitor clinical trials."

 
Morton says it is
important to have a well-trained staff or use a CRO when conducting a clinical trial.

Installing the right people to manage trials will not only avoid possible legal action; it may also prevent scrutiny from FDA. "Over the last several years, FDA has indicated that the device industry is going to face increased scrutiny," says Mayo. "The industry has a sort of cowboy image of getting by with less-than-stellar clinical research."

Mayo adds that industry tends to think that device trials are completely different from drug trials, and that they don’t need the same scrutiny. This is not the case, he warns; FDA tends to treat them the same.

"The advice I give any company is to do good-quality work. Make sure everyone understands the regulations and knows the expectations," says Michael Hamrell, president of Moriah Consultants (Yorba Linda, CA). "What’s most important isn’t necessarily avoiding litigation, but having data that are acceptable to FDA."
Before embarking on the clinical development program of a new device, Mayo offers companies two pieces of advice:

• Consult with a CRO or someone who has at least 10 to 15 years of experience. Bring the person into the company as a consultant or an employee. Don’t try to form a clinical research department solely from your self-grown staff.

• Take advantage of technologies such as electronic capture and project management systems. These will help you collect quality data and help you have a better grasp of what’s happening in your studies.

What does the future hold for device companies and potential litigation? "My suspicion is that a lot will depend on the outcome of the lawsuits with Merck," says Morton. "That outcome will have a major effect on both drug and device trials." In mid-August, drug company Merck & Company, Inc., was found liable for more than $250 million after a jury found that its painkiller Vioxx caused a death. However, the company is appealing.

With all the recent attention given to adverse health events in both the drug and device industries, device companies will probably face more challenges in the future. "The clinical trial process is getting more complicated, and it is harder to develop a new device than it was in the past," says Mayo. "The industry has to recognize that the trend is going in that direction."

 By Maria Fontanazza

Copyright ©2005 Medical Device & Diagnostic Industry

Originally published October 2005