Drug design – the process of discovering new molecules that eventually become prescription medications – is complicated and costly. In fact, research from the Tufts Center for the Study of Drug Development points out that this multi-phased endeavor costs an average of about $2.6 billion.
The drug design process is a challenge in healthcare that calls for the better use of data at every turn. The utilization of connected digital devices can help, as gathering remote clinical information can enable pharmaceutical companies to collect more data, more efficiently, according to John Turnburke, senior vice president of business development at Validic. Here, he calls attention to four specific ways that pharmaceutical organizations can leverage data from mobile health and in-home clinical devices during the drug design process:
1. Identifying possible clinical trial participants. Contract research organizations (CROs), which conduct studies on behalf of prescription drug manufacturers, nurture communities of people who share a common disease state. These communities enable patients to support one another and CROs use these groups to identify potential clinical trial participants.
When community members use digital health devices and applications to share information, they can identify trends, view similarities or commonalities, and, in general, provide more specific support to one another. Additionally, the data from these connected devices can help CROs identify which patients are most appropriate for specific clinical trials, a task that is said to account for about 70 percent of the total costs of trials.
2. Collecting data during clinical trials. When clinical trials commence, researchers typically initiate a rigorous set of focused measurements to determine exactly how the molecule will metabolize. They also zero in on potential side-effects. As such, they need to constantly monitor participants' vital signs to verify if they are responding positively or negatively.
Digital health devices can significantly streamline this process. If trial participants collect this information via a mobile device that transmits data back to clinicians, the need to conduct costly in-person evaluations diminishes. As a result, participants do not need to drive to a clinic several times a week but can instead simply transmit their vital signs from home. In addition, the convenience makes it possible to shorten the duration of a trial, as the necessary information can be amassed quickly and more conveniently.
3. Developing a holistic view of patients' disease states. Pharmaceutical companies typically offer a medication that only treats a specific disease. However, the prescription drug is only one variable affecting clinical results and the patients overall health. For example, diabetic patients not only need to take their medications to manage their condition but also must pay attention to diet, exercise, nutrition and stress. Collecting and analyzing various lifestyle-related data via digital health devices can help researchers arrive at a holistic view of a patient. This makes it possible to pinpoint the combination of factors that will lead to overall improved health.
4. Monitoring long-term efficacy. After receiving Food and Drug Administration approval, pharmaceutical companies still need to verify that the new molecule is fully delivering on its promise. When patients use mobile devices to collect health data, drug makers can keep tabs on long-term effectiveness. Such surveillance can result in an understanding of the drug's real world, long-term value. As such, pharmaceutical companies can make adjustments or recalls, sooner rather than later – avoiding the costs associated with large-scale recalls or court settlements.
Leveraging digital health technologies in the drug design and testing process allows for not only a streamlined and more efficient creation process, but also for more innovation to take place in combining drug therapies with mobile prescriptions. Pharma is the next frontier in digital health innovation.