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RFID can speed time to market for new drugs
by improving the accuracy of clinical trials

03/21/11 | John R. Johnson | email

RFID usage is exploding in all industries. The technology has the ability to revolutionize the retail industry, manufacturers have real-time visibility into production facilities around the globe, and all kinds of social media apps are being developed that utilize RFID.

But the biggest sweet spot for RFID lies in the medical and pharmaceutical sector. Sure, it's cool to use RFID to retrieve pricing information about a product on the retail floor and to buy that product without standing in long lines. It's fun to track your ski runs at Vail through social media apps like EpicMix. But the solutions being developed for pharma and healthcare can save lives. What's more intriguing than that?

This week's issue examines how RFID is expediting drug development by simplifying the clinical trial process.

"It's a burgeoning area because one small error in their data could throw off the entire product roadmap for getting a product into production and accepted by the FDA," says Drew Nathanson, director of research operations at VDC Research. "Drug companies have billions invested in these products, so there is a lot at stake."

By the time a drug reaches the stage where it goes before the FDA approval, drug companies may have invested hundreds of millions -- if not billions -- into the development of the drug. It's essential to have all record keeping and trial results in impeccable order when drug development reaches the approval stage. But that doesn't always happen. To date, nearly all clinical trials have relied on bar coding to track results during each step of the trial. Like all industries, that can lead to slowed or flawed data collection and inaccurate results.

Enter RFID for clinical trials, which can not only collect data quicker and more accurately, but also track and trace samples from around the globe as they move through the clinical trial process. Joe Pleshek, CEO of Madison, Wisc.-based Terso Solutions, says that the last six months have seen a flurry of customers interested in RFID-enabled solutions for use in clinical trials. Terso produces temperature controlled cabinets and other products that can be used in those applications.

T.S. Rangarajan, an RFID expert and a principal consultant with Tata Consultancy Services, worked with a major provider of clinical trials from Switzerland on a pilot to examine the advantages of RFID technology instead of bar codes. Rangarajan notes that trial results need to be documented during each stage of the complicated trial process, meaning that drug firms must rely on numerous bar code reads, which are often inaccurate. For example, in a lab environment, bar codes can become smudged and be unreadable. Or, if the trial drug requires a temperature sensitive environment, bar codes might be unreadable because of frost or condensation build-up from refrigeration.

"Using bar codes was a very manual and tedious process for the type of data collection they needed," he says. "The primary reason they were contemplating the use of RFID was because of the obvious need for frequent verification of the bar code at each stage during the trials."

In addition, samples collected in the field have a very short shelf life, and typically need to be processed within 24 to 48 hours of arrival. Going beyond that window can jeopardize the authenticity of the clinical trial.

"There is generally very little time to process the sample within the lab," says Rangarajan. "They wanted to avoid the delays that were happening with bar code scanning by allowing the samples to reach the lab, let the scanners read them, and move on."

It's also crucial for clinical trial providers to possess a complete paper trail (or in this case, an electronic trail) for the samples they are processing in case they are audited. Clinical trials are monitored very closely in the U.S. and in Europe, "so they wanted a fool proof method of associating samples with the people from who they were collected because of the legal issues associated with compliance," says Rangarajan.

In the event of an audit, RFID would allow the clinical trial provider to quickly prove where the samples came from and where they were processed, and also to account for samples that were taken but were not tested or processed. That's critical considering that some clinical trials gather data from tests that are conducted around the world, in urban centers and more remote rural areas.

RFID technology can also be beneficial when the drug being tested requires a temperature controlled environment. RFID and sensor technology can alert clinical trial providers if a certain temperature range has been violated, therefore sending a red flag that the sample might need to be discarded. Without RFID, that sample could be entered into the collected data and skew the results.

"The biggest benefit they gain is having the visibility of the sample and that its current status can be seen from anywhere in the world," says Rangarajan. "They can actually can see where a particular sample is, just like how you track your FedEx package today. If you can track a sample through its lifecycle, that gives confidence to the drug company that the samples are being tested correctly."

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