Wireless Medical Blog
Can wireless connectivity save Big Pharma millions?
By Vaishali Kamat - Last updated: Monday, May 17, 2010As I strolled through the technical posters and exhibit stands at the Respiratory Drug Delivery (RDD) conference this year, I kept thinking about the hundreds of millions of dollars that pharmaceutical companies need to spend on new drug trials. With the FDA increasingly demanding more post-market data the costs are only going to increase unless something different is done. Knowing that a large portion of the cost is attributed to patient recruitment, and data gathering/ analysis, I couldn’t help but see the low hanging fruit – a different yet practical solution – that could drastically improve the current state of the art.
In an ideal world, clinical trial participants would be 100% compliant with the trial protocol, diligently reporting outcomes, and enabling straightforward proof of drug efficacy, assuming of course that the drug is fit for purpose. In real life however, trials significantly over-recruit, as participants often drop off, do not comply with protocol or just don’t bother reporting data. Compliance with paper reporting ranges between 11-20%. Moreover, correlating efficacy with compliance is a real challenge.
In the last decade pharmaceutical companies began embracing technologies such as Electronic Data Capture, which has somewhat streamlined data collection. However, the process is still far from automated and does not provide actual compliance information. Tracking participant compliance to established protocol, providing regular reminders for medication regimes, and automatically transferring data to a designated secure server, could significantly reduce clinical trial costs and could even speed up regulatory approvals and time to market.
The good news is that all this feasible today and the necessary technology is readily available. The answer lies in wireless sensors embedded within drug delivery devices. Cambridge Consultants’ first unveiled the Connected Inhaler concept at the RDD conference in 2009. The concept uses our Continua compliant Vena platform and demonstrates how wireless connectivity and availability of data can enable new business models centered on the patient.
This year at RDD, we demonstrated how the same connectivity solution could be added on to existing devices solely for use in clinical trials, without affecting drug delivery performance, drug stability or regulatory complexity.
Our ongoing discussions with a variety of partners is strong evidence that it won’t be long before the leaders break through the traditionally conservative mindset of the drug delivery devices market and forge ahead with such innovative solutions. The race is on to determine who will be first but it will be more interesting to watch how quickly the ‘fast followers’ are able to catch up.
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