Has anybody ever asked you to remember a certain event, and you reply that you can’t even remember what you had for lunch yesterday? This kind of exchange points to the challenges many of us have with recall. Accurately remembering details after a period of time has passed can be challenging – even more so if you’re not feeling well.
That’s why the electronic tracking and delivery of symptom improvement information by patients in pharmaceutical trials is so important. It simplifies the entry of information by trial participants, can remind patients at regular intervals to enter information, and immediately sends that data to the trial sponsor. This process, of course, is dependent upon an available and reliable network that will get the information where it needs to go.
That’s why ERT selected Vodafone as its M2M business partner. ERT is a leading provider of high-quality patient safety and efficacy endpoint data collection solutions for use in clinical drug development. The company caters to pharmaceutical companies and contract research organizations that aim to better understand the effects of new treatments by collecting information from trial participants.
Clinical trials are conducted globally, and ensuring every patient and clinical investigative site can enter and send critical data regularly and reliably can be challenging, as connectivity is not uniform across the world. Partnering with Vodafone has given ERT greater flexibility and reliability in data connectivity across the globe, helping to increase end user satisfaction with the company’s electronic clinical outcome assessment (eCOA) system.
“Vodafone’s strength is in international capability,” said Scott Dixon, ERT’s vice president of marketing and corporate strategy. “Vodafone, with its global reach and footprint, allows us to expand our service offering around the world.”
Other clinical trial data collection companies fail when they go into a new region, Dixon said, but that’s not the case for ERT because it has partnered with Vodafone, which offers clear worldwide connectivity. Because Vodafone has a global network footprint, ERT doesn’t have to manage multiple local providers and SIMs. In fact, over the next three years, ERT will deliver thousands of tablets embedded with the Vodafone M2M SIM to clinical research sites across North and South America, Europe, Asia, and Africa.
Clinical trial participants with Vodafone-connected tablets, and other wireless devices including smartphones, use these technologies to record information about their symptoms and experiences. (ERT and Vodafone also collect and transmit data from medical devices like glucometers and the like.) Those wireless devices connect with ERT’s study management and patient data portal over the secure Vodafone global M2M network where all patient trial data is then available for review.
Having trial participants enter symptomatic data or collect data directly from connected devices through Bluetooth or cloud-based integrations rather than on paper – which is the traditional method, makes for more efficient processes and more accurate trial results. It lessens patient burden and helps prevent what the industry refers to as parking lot syndrome, Dixon explained, which is what happens when trial participants wait to fill out their diaries until they are in their cars just before a visit at the clinical research site.
Leveraging M2M technology and mobile devices and programs in clinical trials also drives more accurate results because it allows the organization to send patients reminders asking about their health status. That, Dixon said, can be especially helpful in trials involving asthma patients or people who suffer from migraines, as just two examples, because an asthma attack or a headache can be debilitating. So checking in with the patient at various intervals asking if he or she has a particular symptom helps ensure the individual experiences are recorded in real-time and alerts are delivered to site staff so decisions can be made prior to an in-person visit.
All of the above can save both time and money for pharmaceutical companies, which spend an average of approximately $3.6 billion to get a single drug to market, Dixon said. Electronic entry and M2M means pharmaceutical companies and their partners don’t have to over recruit patients for their trials, and can collect trial data faster and more efficiently. As a result, he said, they can avoid sinking more money into projects that don’t have promise, and they can expedite efforts to get effective drugs to market.
“Vodafone’s M2M technology is helping to transform lives,” said Andrew Morawski, Vodafone’s head of M2M for the Americas. “We’re delighted to work with ERT to enhance the effectiveness of clinical studies and make it easier to develop safe and innovative treatments for patients.”
Edited by Ken Briodagh