I recently discussed both the merits and needs for the use of mobile technologies in clinical trials. Recruiting patients via social media is now a reality and has been a topic of discussion in many forums, including mainstream medical journals. There is no question that online patient support groups serve unique purposes. There are regulatory issues involved in this arena.
However, new regulatory frameworks need to be developed in the age of digital and mobile trials with considerations to technology and patient populations. To be more specific, mobile technologies have unique issues to address. Crowdsourced clinical studies have been recognized as an emerging aspect of clinical research for years. Even funding for medical research has found its way to the masses. Regardless of changes in the paradigm of conducting trials, patient safety must always remain a priority of study designers and investigators (whether organizational or subject investigators). The subject of health literacy is extremely important today. It is recognized as a major determinant of patient engagement. Health literacy is a critical factor in pharmaceutical and device labeling and is paramount to user experience of a mobile health app of any kind.
Improving patient recruiting, retention, and data collection should be the priorities of any mobile technology in this space. I am going to discuss why we can and need to adopt mobile technologies for clinical trials now.
1. Corporate giants are paving the way. Apple’s ResearchKit is a pioneering effort to accomplish many objectives. Its present offerings will not cure heart cancer (though arguably, if optimally utilized in association with other tools by both providers and patients it might prevent them). What it will do is to markedly increase awareness and enthusiasm of the public as well as the health care provider community to participate in clinical trials. ResearchKit’s present apps are primarily geared for wellness, with monitoring via smartphone sensors initially, but the satisfaction of participating in research and the sense of empowerment that participants will experience will pay huge dividends with regards to more disease-oriented research down the line. In addition, and not to be minimized, it will facilitate the adoption of mobile technology in general in the wellness and health care arenas.
2. The technology is here. One might intuitively think that a clinical trial mobile app might simply consist of a technology limited to data and symptom entry. But the dynamics and workflows of all phases of a clinical trial make that a recipe for poor recruiting and lack of patient engagement and thus retention. Parallel 6 is a company which utilizes patented technology in its end to end mobile clinical trial technology for improving both the recruiting and retention of study subjects. In addition, pharmaceutical companies are realizing the power of crowdsourced studies. This is illustrated by the partnership deal between Genentech and 23andme. These kinds of partnerships themselves spawn proliferation of mobile clinical trials.
3. Traditional evidence-based medicine is no longer considered infallible. As I have previously reported, there are significant cracks in the foundation of evidence-based clinical trials. Some of these cracks may be due to well-publicized gender bias possibly related to recruitment practices (see below). These biases have been recognized by the FDA and stressed as a priority of attention in the recruiting of study subjects. Social media as a source of study subject recruitment has multiple appealing aspects. It can facilitate recruitment of patients with rare diseases who reside in widely dispersed geographical regions. One study found that patients who are actively engaged in the use of social media for health care information are 60 percent more likely to have participated in a clinical trial compared to the general population. Clinical trial recruitment via social media can potentially decrease gender bias, leveling the clinical trial subject playing field. Amy Ohm, the CEO of Treatment Diaries, a large and successful online cross-disciplinary collection of support groups states that 73 percent of the site’s participants are female.
4. Traditional clinical trial research is becoming financially unfeasible. The cost of clinical trials is discouraging both sponsors and health care enterprises from conducting traditional clinical trials. The cost of even a market approved medical device trial for a new indication is tens of millions of dollars. The cost of clinical research nurses and coordinators has become prohibitive for institutions except those most famous or endowed. Although most research today is sponsor-driven, research by physicians in smaller hospitals and organizations is cost-prohibitive. Mobile technology can potentially assist in this regard. Even clinical research organizations (CROs) are looking to decrease costs and improve efficiency. The cost reduction projected for each phase of a trial in multiple disease state areas with the use of mobile technologies has been estimated in a recent report by the Department of Health and Human Services. “In Phase 1, the highest savings are $0.4 million (immunomodulation and respiratory system). The savings range from $0.5 million (cardiovascular) to $2.4 million (hematology) studies in Phase 2. In Phase 3, the highest savings that can be expected from the adoption of mobile technologies is $6.1 million (pain and anesthesia). Finally, the range of savings in Phase 4 studies is $0.7 million (genitourinary system) and $6.7 million (respiratory system).”
5. Mobile can improve trial safety and efficiencies in clinical workflow. With the collection of more data in real-time, the improved efficiencies produced with mobile technology might theoretically improve patient satisfaction, study subject retention, and the aforementioned cost to study sponsor and investigators. In addition, earlier reporting of adverse events might translate to safer patient outcomes. I truly look forward to pharmaceutical and medical device companies, CROs, payers, and health care institutions saving money which can be better utilized with the use of mobile technologies for clinical trials.
David Lee Scher is a cardiac electrophysiologist and a consultant, DLS Healthcare Consulting, LLC. He blogs at his self-titled site, David Lee Scher, MD.
