Apr 27, 2007This article was originally published by RFID Update.
April 27, 2007—Developing new drugs takes a lot of time and a lot of money. RFID can help save both, especially during the clinical trials phase, according to a study released this week by ChainLink Research.
"I believe RFID technology is ready. The challenge is more in the clinical trial process. It's a cultural issue," Bill McBeath of ChainLink Research told RFID Update. "The expense to pharmaceutical companies is in changing processes as much as it is in RFID equipment and tags. The single drug doses used in trials are very expensive to develop, so the cost of RFID is relatively small."
ChainLink's study, "RFID in Clinical Trials - Accelerating the Process," is based on interviews and surveys of industry professionals. ChainLink found no respondents who are actually using RFID for clinical trials, but uncovered possible uses for the technology and belief in its value.
"Clinical trials are very data intensive. You need to accurately manage data on who is receiving what items in the trial, and you're also collecting data about the manufacturing process," said McBeath. "Data is fed to the FDA for the approval process, and also to determine the best way to manufacture. There is potential value in using RFID to collect the data more accurately."
RFID could be especially useful for recording drugs and placebos issued to participants, monitoring delivery conditions, and tracking batches of materials and compounds. These uses rated highest when respondents were asked if they saw potential value in using RFID for specific applications.
"People do see the value in RFID, even though they're not using it," said McBeath. "For each use case we presented, only 10 to 12 percent of respondents said they saw little or no value in using RFID."
Tracking batches of materials and formulations and making sure they are stored in proper temperature and environmental conditions is already a large challenge, according to McBeath, who said the challenge will grow as more drug activity is outsourced to contract researchers, a growing trend.
ChainLink suggested that RFID could also be used to record when drugs are issued to participants and even when they are taken. Respondents saw strong value in these applications, especially since inconsistencies in when drugs are taken can negatively impact trials.
However McBeath cautioned monitoring applications may be impractical because participants in the trial would need RFID reading devices. The most practical potential clinical trial applications involve tracking at the raw material, compound, and dispensing levels.
The business case in the drug discovery industry is more favorable for RFID material tracking than it is in most others, because drug development requires multimillion dollar investments and takes years to complete. An RFID infrastructure could be a relatively small incremental expense.
"One of the areas pharmaceutical companies focus on most aggressively is the time from the discovery of a compound to its delivery to the marketplace. Materials are typically in the pipeline for eight to 10 years. Companies want to compress that cycle. One of the ways to do that is by eliminating mistakes," said McBeath.
"RFID has some potential to compress the cycle. I don't want to overstate it -- it won't save years, but maybe weeks. And each week is worth a lot."
The pharmaceutical industry is one of the largest and most innovative users of RFID technology, but clinical trials are not usually cited as a priority. RFID is also commonly used in labs, but typically for asset and sample tracking, not for test data management. Clinical trial applications may emerge considering the general open-mindedness ChainLink discovered regarding the potential benefits of RFID and the expected increases in RFID investments by pharmaceutical companies (Health Industry Insights recently predicted a tripling in RFID investment -- see Analyst Outlines Hurdles to RFID Adoption). Clinical trials are also good RFID candidates because information and materials are tightly controlled and may only be exchanged with a few research partners, alleviating the need for industry standards.
The clinical trials report is the third in a series of ChainLink Research reports on RFID in the pharmaceutical industry. Executive summaries for all are available from the company's Web site.
