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Report from Montreal: Operational Excellence in Clinical Trials Summit

by Dan McDonald

At the Operational Excellence in Clinical Trials Summit meeting in Montreal in September, I had the privilege to serve as keynote speaker and a panelist for several discussions. The conference brought together industry thought leaders in the area of patient engagement, study feasibility, and clinical study conduct.

My presentation focused on the gap that exists between leading-edge approaches to patient engagement – frequently featured in industry trade journals and conferences – and the actual day-to-day approaches to patient engagement taking place in the industry. In the session, I referenced the growing presence of consumer, retail, and technology companies in the health care space. Specifically, how these companies have created efficient pathways for consumer engagement and the delivery of goods and services. Expectations are being set with younger generations and this is largely at odds with the experience the clinical research industry is delivering to its patient partners.

I shared news and trends related to technology companies increasingly owning the relationship with the consumer. In that, they are finding new and efficient ways of driving change and the consumer is getting used to that. A warning is called for – who is to say that these organizations and the environments they have created will not bypass us if we continue down the slow and steady path? As an example, a 2017 survey by Accenture found that eight out of 10 Americans would welcome some aspect of virtual health care, but only one in five providers are meeting that need. Furthermore, light metrics show that 30 percent of millennials do not have a primary care physician, or subscribe to our 100+-year-old brick and mortar health care system.

The news is not all bad from my perspective. Some cool things are going on in our industry in terms of innovative approaches to patient engagement. The disruptive innovations conference “D-Pharm” in late September in Boston highlighted many of the companies that are operating in this space. Some are high tech and some are field based, but there are some very innovative things going on out there to move the focus of trials away from the study site. Examples include ELLIGO, physIQ, Science 37, Deep 6 AI, Saama Technologies, etc. These advances are helping our industry figure out ways to decentralize research away from the study site, which is making trial participation easier for people, while helping to drive down cost. Unfortunately, though, adoption rates are very low. Large biopharmaceutical companies are piloting the use of these technologies, but only on a small fraction of their studies – maybe five in 200. So while there is plenty of hype around their use, the fact is, any sort of mass migration is years off.

To bring the gap to life, I shared the results of Imperial’s survey of front-line clinical operations personnel at sponsor companies.

The survey, which concluded last year, examined the attitudes and behaviors of clinical operations personnel most responsible for patient recruitment and retention at their organization. The findings demonstrated that the most sophisticated approaches to patient engagement might be in the piloting stage with sponsor companies, but in general, adoption was very low, in favor of approaches that are more traditional. For example, when we asked sponsors which types of strategy they used most, traditional recruitment materials (think posters, flyers, brochures) were higher than any other approach. The second was the use of medical community outreach programs.

The presentation concluded by ending where we started – a discussion about the future of patient engagement and where our survey respondents saw things going in the next five years. The audience agreed with our findings – that the use of smartphones and wearables to capture patient clinical data had the largest likelihood of affecting the space. Likewise, both our respondents and the audience saw an increasing role for labor-intensive, but much needed, at-home study support by visiting nurses. In aggregate, the post-presentation discussion and other sessions ultimately lead most attendees to one conclusion: The industry is making advances in how we engage patients, but the concern is whether those advances are fast enough to satisfy patients/consumers who are growing accustomed to instant information and same day services. Time will tell.

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