The new site for clinical trials: Your home

Ben Comer Senior Manager, Health Research Institute, PwC US September 14, 2018

New digital tools and services can help biopharmaceutical companies overcome the delays and bottlenecks endemic to drug research and development and can improve patient experiences and retention during clinical trials. Making trial participation more convenient and relevant to patients can help bring new drugs to market more rapidly and distinguish products in competitive therapeutic areas.

While the biopharma industry has begun to adopt new tools, such as artificial intelligence for data analyses and devices for digital data capture, most companies aren’t using technology to enable trial participation outside a testing facility, despite the cost savings, added convenience for patients and other potential advantages.

The background

Consumers increasingly want to receive healthcare services at home, according to HRI research.
The traditional clinical trial process requires that patients travel to testing sites, which can prevent participation and slow trial enrollment.
The physical location of a research center is the third most important factor influencing a patient’s decision to participate in a clinical trial, behind the trial’s potential risks and benefits, and its purpose, according to the Center for Information and Study on Clinical Research Participation (CISCRP).
The average duration of a study is one year, including an average of 6½ visits to a medical center. Site-less trials could eliminate many, if not all of these visits.
Using lower-cost facilities and in-home testing can reduce per-trial costs by $4.3 million in Phase 2 trials, and $9.1 million in Phase 3, depending on therapeutic area, according to a US Department of Health and Human Services analysis.
Among R&D executives surveyed by HRI, only 8 percent had conducted a trial that included remote clinical data collection outside of a medical facility, although 30 percent of executives representing the largest biopharmaceutical companies reported using remote data collection.

The data

HRI impact analysis

Ninety-one percent of pharmaceutical and life sciences executives surveyed by HRI said patients will increasingly manage their health at home over the next 10 years through pharma patient engagement services such as drug adherence programs and health management apps. Of those that haven’t used remote data collection for trials, 25 percent said they will consider trial protocols with remote data collection in the next two years. Seventy-nine percent of executives from the largest companies said they would.

Biopharma R&D won’t be able to shift to fully remote trials overnight, but the transition is happening; taking steps now to build organizational support for new trial designs, protocol feasibility, patient identification and overall stakeholder management and communication is critical. These companies need to consider novel trial designs with platforms that use artificial intelligence and data sets generated in the real world, using digital devices.