The clinical trials industry has been slow to adopt technology, despite the abundance of new technologies that have emerged over the past decade and the rate of adoption by consumers. In the early 2000s, clinical trials began moving from paper and forms processing to Electronic Data Capture (EDC). The resultant increases in data accuracy and efficiency have been significant and, as the EDC systems evolved and study managers became more adept at deploying them, have continued transforming clinical trials to provide significant improvements in the execution and effectiveness of studies. In retrospect, many argue that the introduction of EDC was the last major technological enhancement to the clinical trials processes.
The iPhone will be 8 years old this June, and Android phones are a little more than 6 years old. In just that short time, you’d be hard-pressed to find someone that doesn’t own a cell phone. In fact, almost 2/3 of American adults own a smartphone. Moreover, 62% of smartphone owners have used their phones to research information about a health condition.[1] Yet despite the prevalence of smartphones and mobile devices, as recently as 2013 only 35% of patient-reported outcome (PRO) or clinical outcome assessment data (COA) data is captured digitally.
The clinical trials industry is notably risk-averse, and the risk-aversion carries over into the use of technology. Any change that may risk patient safety or run afoul of regulatory oversight is viewed skeptically. Industry analysts clamor for broadening the use of technology to help reduce the cost and duration of clinical trials and to improve their effectiveness. Yet despite the obvious benefits of using technology, ranging from more accurate and timely data to providing better data to support product differentiation, there has been little movement in implementing technology into the process.
As the FDA comes under continuing and increasing pressure to define its positions on the use of technology and social media, and more importantly to get its arms around how technology can help it more quickly approve safer treatments, the rate of introduction of technology into clinical trials must and will increase. Two of the trends that will most affect clinical trials are mobile computing and social media.
Mobile Computing and Data Gathering
Smartphones, and more recently, wearables, hold tremendous promise for making clinical trials better and more efficient. Mobile Health, or mHealth, solutions are expected to be an $8 billion market by 2019. The benefits of incorporating mobile devices into clinical research activities range from identifying potential study participants to gathering information directly from a subject in real-time from a wearable device.
Monitoring and diagnostic devices like cardiac-monitors, glucose monitors, and blood pressure monitors that connect to smartphones are becoming more commonplace, and make it easier than ever to collect data. Apple was recently awarded a patent for ear buds that can monitor a person’s vital signs while they listen to their music. Hundreds of apps and devices are available that can track heart rate, blood pressure, body temperature, sleep habits, and other critical patient data.
All of this data poses challenges to both clinical research and to regulators. For the researchers, the risk of “data overload” increases as more data is generated. Researchers can get caught in a cycle of accumulating more subject data, but not knowing if all of that data is necessary, useful, or reliable. Regulators must grapple with privacy issues, striking a delicate balance between securing a subject’s medical information and enabling accessibility to authorized processes.
There’s no doubt that the inclusion of mHealth solutions in clinical research will continue to gain momentum. The benefits are simply too great to ignore. The key will be to implementing them securely and in such a way as to provide valuable data while making it easy for subjects to comply.
Social Media’s Influence on Clinical Trials
From study design to subject recruitment and beyond, social media is playing an increasingly important role in clinical trials. For example, researchers are using crowdsourcing – obtaining needed services, ideas, or content by soliciting contributions from a large group of people, and especially from an online community – to obtain subject input on protocol design, on the premise that subjects will have a better experience and that the barriers to trial entry will be reduced.
But there’s a downside to how social media impacts research. Clinical trials have long held to a central principle: Researchers and subjects must both be “blinded” as to who is getting the experimental drug and who is getting a placebo or standard therapy. Social media has lifted the veil on drug trials, and study subjects routinely go online to exchange their experiences and to search for more information. Researchers worry that online conversation could unravel the carefully built constructs of a clinical trial. They worry that subjects may drop out of a study if they suspect they aren’t getting the drug being tested, or may report symptoms inaccurately because of the influence or suggestions of others in the trial.
Although there are clear examples of how social media can be implemented effectively, most researchers are waiting for clear guidance from the FDA before committing to a social media strategy. The is a significant opportunity to improve funding by improving enrollment rates and getting trials started sooner for those that successfully embrace and implement social media.
Summary
In just a few years, the technology landscape has changed dramatically. Many industries are recognizing this new landscape and are adopting strategies to benefit from it. The seemingly unlimited access to the Internet from almost anywhere, the proliferation of mobile devices and platforms, and the ability to capture data from any person provides tremendous opportunities for organization to connect to and interact with consumers.
The ability of the clinical trials industry to incorporate these new technologies is lagging. Clearly, there are tremendous benefits to identifying how these new technologies can positively impact clinical trials and implementing them effectively. But several obstacles still remain; FDA guidance must be more clearly defined, privacy and data security risks must be identified and mitigated, and studies must adapt to embrace the influence and of social media on study validity. Once these hurdles are cleared, the industry must find ways to ensure these and future technological advances can be incorporated into a process that will mean better, safer, and more inexpensive treatments that are submitted and approved much sooner.
[1] U.S. Smartphone Use in 2015, http://www.pewinternet.org/2015/04/01/us-smartphone-use-in-2015/