As the first installment of the two-part series on digital health's impact on pharma, CEO Ryan Beckland addresses subject recruitment and patient data.
The recruitment and enrollment process for clinical trials for drug development is a major challenge for pharmaceutical companies. In fact, this phase alone consumes about one-third of the time allocated to the average clinical trial, and most trials significantly extend their timelines due to the inability to find enough patients. According to a Tufts study, each additional day can cost a company $37,000 in operational costs and $1.1 million in lost revenue. However, digital health devices—such as wearable technologies—provide new and better options to enhance subject recruitment for clinical trials. The following factors and use cases highlight their value.
Participants want them and will use them. In 2015, Biogen, PatientsLikeMe and Fitbit worked together to conduct a study to investigate whether patients with multiple sclerosis found it useful to track their activity using FitBits. Within 24 hours of launching the study, the companies had enrolled 248 patients, and 77% of them completed the study and follow-up survey. According to Jane Rhodes, Ph.D., senior director of new initiatives, Innovation Hub at Biogen, “The process was remarkably seamless and showed us there was a significant population of patients who were willing to self-quantify and share their mobility data.”
They can help identify new areas for research. At Icahn School of Medicine at Mount Sinai in New York, a team used Apple’s ResearchKit framework to develop their free Asthma Health app. Fifty thousand people downloaded the app and the study enrolled more than 8,600 participants within six months without any direct, in-person contact with researchers. In fact, only 13 percent of those who enrolled lived near the study site. Kara Dennis, managing director of mobile health at Medidata Solutions, highlighted the popularity of the framework: “We’re working with a number of sponsors who are excited to recruit patients using ResearchKit…Mobile health technologies – including wearables, sensors and apps – can help reduce the number of visits to sites and make the trial experience easier and more comfortable for patients.”
They offer a constant stream of data. By using wearable devices in clinical trials, consumers can passively track their health data 24/7, which ensures accuracy and optimizes the use of real-time data that is captured in the context of participants’ daily activities. This method of passive data collection enhances trial adherence and provides higher quality data, insights into individual and population trends, and contextual information related to prescription therapies. Proteus Digital Health is one company focused on providing such insights regarding medication adherence.
They expand the depth of clinical data. Wearable devices coming to market over the next year will collect even more biometric data as biosensors advance—promising to expand the type of data researchers can ultimately collect and analyze. Examples include the continuous measurement of pulse transit time, as well as sleep data—each of which could be applied to a number of research scenarios.
The use of wearable technologies in clinical trials to enhance subject recruitment will continue to support cost-savings and maximize efficiencies—and potentially revolutionize how pharmaceutical companies conduct such trials to obtain optimal results.
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