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Pharma sees great RFID opportunities for clinical trials

By Emilie Reymond , 02-May-2007

The pharma industry sees great opportunities in using Radio Frequency Identification (RFID) technology during clinical trials, a new survey has revealed.

The survey published last week found that industry players, including contract research organisations (CROs), drug makers and technology vendors, expect RFID to help save time and money during the running of clinical studies. The study, conducted by ChainLink Research, an RFID and supply chain research firm, revealed three main areas of clinical trials where industry was anticipating great take up in the use of the technology. The first was for monitoring dispensing of placebo versus active compounds. Secondly, the survey participants said that the technology could be useful for tracking the correlation of dispensed drugs to patients' outcomes, and finally using RFID could help monitoring the state of products, for example making sure temperature sensitive products are kept in the right conditions. "Temperature sensors could be integrated to RFID tags and programmed to record temperature changes," Bill McBeath, chief research officer at ChainLink Research, told Outsourcing-Pharma.com. He stressed that RFID has got even greater potential to prevent mistakes as these are areas that currently rely on manual data capture, prone to errors and inefficiencies. "We found that industry participants saw in what we call a 'single version of the truth' (SVoT) great potential in terms of facilitating accurate data sharing and reducing time to market," said McBeath. With the increasing number of players and steps in the running of clinical trials - due largely to outsourcing to CROs and Contract Manufacturers (CMOs) - synchronising on a SVoT is seen as solution to help coordinate activities while working with the same data. According to the study, the data could be integrated into existing information systems, creating a 'single system of record' in critical data that could be shared by all participants. Although McBeath stressed that it was still too early to tell exactly how much time could potentially be saved, he insisted that the main benefit was the prevention of human mistakes in data recording. He also said that ChainLink found no respondents who are currently using RFID technology for clinical trials although they were all optimistic as to its potential. Another interesting finding of the survey, said McBeath, was that vendors of solutions tend to under-report the actual adoption of RFID technology in general, not only for clinical trials. "Our survey found that vendors' estimates were lower, which is surprising," said McBeath. "I guess that one of the reasons could be that they have overestimated RFID adoption in the past and have been disappointed and this could now have an effect on their estimates." The RFID market is estimated to grow at 20 per cent annually and this figure is even higher in the pharma industry, where the market for RFID tags is set to increase from $90m (€70m) in 2006 to $2.1bn in 2016 mainly driven by the demand for more convenient and anti-counterfeit solutions in pharma packaging - "smart packaging" - to ensure product quality and usability, and improve supply chain efficiency and security. Furthermore, a forecast report published last year suggested that the market for smart pharma packaging growth will be driven by the need for new clinical trial compliance and brand protection measures. The report said that several companies recently developed a range of novel RFID products. Such products include IMC's eCAP RFID technology, developed so that researchers could track medication usage during clinical trials without active patient input, by using an RFID "smart tag" embedded into a standard medication bottle cap, which records the time at which the bottle is opened by the patient to remove their prescribed dose, thus logging the patient's medication use. "However, there are challenges and the penetration of RFID technology in the clinical trial market will be very slow as we are dealing with a hybrid system between a closed-loop application and a case of open supply chain," said McBeath. A closed-loop application is when the technology can be re-used as the data does not need to be transmitted among external parties. It is opposed to the situation where there is an open supply chain and the tag is being transported to multiple parties. "Here, it is a hybrid system where multiple players have to invest in the technology which means there is a notion of interoperability that comes into play," said McBeath. He also cited the existing technical challenge of tracking what doses are administered to which people during a trial, as tags have not been used for individual doses so far. Finally, the financial aspect with the high level of investment was also a hurdle and could represent a barrier to future adoption growth.

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