The pharmaceutical industry has a profit problem. Large companies in the sector have seen the ROI on R&D projects drop by 69 percent since 2010, with the price to bring new drugs to market surging from US$1.5 billion in 2016 to nearly US$2 billion in 2017, according to Deloitte. But trimming R&D isn't an option—without new products, pharma companies wither and die.
Large pharma companies report a 69 percent drop in ROI on R&D projects since 2010.
One solution is speed, meaning clinical drug trial projects that are completed faster and more efficiently—but still safely. To achieve that, some companies are turning to new tech and agile delivery approaches. Novartis AG's new CEO is pushing to implement scrums into projects. GlaxoSmithKline (GSK) and Sanofi are looking to artificial intelligence (AI) and data projects to boost R&D productivity. Last year, GSK launched a US$43 million joint AI-driven drug discovery project with the startup Exscientia.
The benefits of new tech tools and project management approaches go beyond speed—they can also make clinical trials more patient-centric and racially diverse, says Belinda Tan, PhD, co-founder and chief medical officer, Science 37, Los Angeles, California, USA.
Science 37's clinical trial conducted via smartphone app
PHOTO COURTESY OF SCIENCE 37
In October, the startup completed a yearlong clinical trial sponsored by AOBiome Therapeutics. It was conducted via a smartphone app through which participants submitted data. The project team took an iterative approach to developing how patients would use the app and optimizing the trial's app-based workflows, Dr. Tan says. Because outreach to prospective participants was conducted via social media and enrollment was conducted through the app, the process of finding nearly 400 participants for the project was much faster than how patients have traditionally been found for trials, Dr. Tan says.
Some aspects of pharma R&D are the same regardless of whether a project team embraces digital tools or meets patients face to face. For example, all teams must securely manage and store patient health records, coordinate medication delivery and storage, and track patient consent and compliance. For trials conducted virtually, though, teams should prepare to train participants on the tech platform.
At Science 37, the team had to “plan very robust training so that both team members and trial participants understood how to use the mobile platform and who to contact with any issues,” Dr. Tan says. And because the app-based trial wasn't limited to only one city or even state, the project team had to make a plan for juggling multiple time zones with patient recruitment and interactions.
—Belinda Tan, PhD, Science 37, Los Angeles, California, USA
PHOTO COURTESY OF UNICEF
The benefit of finding patients spread across the United States was clear, though: Normally trials involve patients from only one area because they need to meet face to face with project leaders. The wide geographic reach enabled by the app allowed the Science 37 participant pool to be more racially diverse than traditional pools. This will allow the project team to deliver more meaningful drug reaction data to AOBiome.
Novartis and GSK have jumped on the telehealth bandwagon, incorporating Apple's remote monitoring app, ResearchKit, into clinical trials. In a pilot project gauging the ROI of a virtual clinical trial, GSK set a modest goal of enrolling 300 patients with rheumatoid arthritis. After GSK advertised the trial on Facebook, more than 1,100 people downloaded the app. Thirty-five percent went on to provide consent and enroll in the trial, Michelle Crouthamel, the company's platform development leader in clinical innovation and digital platforms, said at a conference last October. Seventy-three percent of people said they would prefer participating in a mobile study over a traditional study or a hybrid design.
The message was clear to Ms. Crouthamel: “Pharma can choose to listen to the voice [of potential patients] or not. I think it would be a missed opportunity if they chose to ignore this.” —C.J. Waity