Originally printed in The Portsmouth Herald (.PDF)
May 3rd, 2010: At a recent gathering of bio/medical professionals in Portsmouth, the question arose above a hush, “Why do we need to bother with clinical trials, is anyone really paying attention? We’re a small company, just getting started. Who cares?”
This topic was front and center for the New Hampshire Bio/Medical Council’s first “Best in Bio” power panel. The fact is, clinical trials are the only way you know what’s going on. Since this is such a complex, but necessary evil, the New Hampshire Bio/Medical Council assembled a panel to discuss this topic in detail.
Jackie Eastwood, co-founder of TissueLink, now Salient Surgical, moderated. She explained that more than 87,000 clinical trials are currently in process with the United States government. Most average 288 patients per trial, 61 percent being for medical devices only. The cost is staggering, about $26,000 per patient for drug trials alone. A necessary cost of doing business if you’re launching anything that touches a patient. Aside from cost, one of the biggest problems is that the people delivering the trials, called investigators, sometimes participate in only one trial in their career. This means that there is not a lot of training or experience accumulated per trial.
John Schwope is the president and founder of Simplified Clinical Data Systems in Milford. His company offers a SaaS (software-as-a-service) that hosts and manages clinical trial data at a world-class data center at Pease Tradeport in Portsmouth. With his roots in workflow, Schwope lent his expertise to a medical company for their clinical trials over a decade ago. His process was so successful that it became a highly specialized hosted software business. He would tell you that his job is to, “Collect, manage, clean, and process your data before it goes to the FDA.”
In fact, they are regulated by the FDA, so they really have to stay on their toes.
“We are experts in (Code of Federal Regulations Title 21), Part 11 and started before Part 11 was even deployed.” Their claim to fame is collecting data quickly and cleanly and clean-as-a-whistle data is what the FDA wants to see.
The other guest speaker was Cynthia Owens, vice president and co-founder ofAsentral, an Institutional Review Board for ethics in clinical research. Although it’s wonderful to know that there are review boards of experts who want to maintain ethical standards for patient trials for the health care industry, the boards are mostly made up of volunteers. She said that 65 percent of all investigators have been involved in clinical trials for less than one year with little training before being put on the job to gather data for a trial ultimately being approved (or not) by the FDA.
Even scarier is the up-trend for research mills, where patients are paid up to $3,000 per study. The risk is that the financial incentive and opportunity to receive free health care can be used to coerce the low-income demographic. The independent Institutional Review Board’s job is to make sure this doesn’t happen, for ethical reasons.
The third expert was Dr. Peter Madras, a former associate professor of surgery at Harvard Medical School, and chairman of the Massachusetts Board of Registration in Medicine. He retired from the active practice of surgery in 2001, and is currently on the research staff at Lahey Clinic, plus Director of New Technology at Pluromed and chairman of Asentral, Institutional Review Board.
Dr. Madras remarked that 10 years ago it cost $1 million per day for each day a pharmaceutical company had to delay a new drug getting to market. That was then, now it’s probably doubled. He describes the central institutional review board as “the wolf guarding the hen house.” It takes eight to nine years to bring a new drug to market and it’s super expensive. You can imagine that for the marketing department, clinical trials seem tedious, expensive, and time consuming. Then, don’t forget, FDA approval. Companies want to get products to market fast so they can begin to recoup their investment. Safety protocols early on can prevent lawsuits and even death of a patient later.
After a few high-profile patient deaths, the spotlight was cast on the potential conflict of interest when the hospital or universities were also acting as their own review board.
When a particular case was investigated involving Duke University and Johns Hopkins years ago, their institutional review boards failed to respond to repeated FDA inquiries.
This created a surge in two things: central/independent review boards and following policy to the letter of the law. This way, ethical integrity for clinical trials could be better maintained using an outside source. Independent review boards such as Asentral, located in Salisbury, Mass. are thriving. They have a star team of experts with credentials a mile long like Cynthia Owens with experience in hundreds of studies, and Dr. Madras, a 30-year veteran.
With Web-savvy software tools and reporting offered by Simplified Clinical Data Systems, plus independent institutional review boards, clinical trials for medical device and pharmaceutical companies can be done cleanly, ethically, and without concern should the FDA come knocking. Why bother? Because our lives depend on safe and sound health care.
For information on the NH Bio/Medical Council, visit: www.nhbiomed.org.
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Catherine Blake, President
Sales Protocol International
cblake@salesprotoocol.com
www.salesprotocol.com