March 9, 2015 | The Summit for Clinical Ops Executives moved to Orlando this year, but the new location didn’t dampen the buzz in the exhibit hall or the session rooms, where conversations centered on innovation, the patient perspective, and finding tools to address the industry’s bottlenecks.

Wednesday’s keynote session saw a panel of experts take on open innovation and cross-industry collaboration in pharma. Ibs Mahmood, CEO of DrugDev, moderated the discussion and challenged the panel to relate the last time they adopted a new technology with a partner.

Katherine Vandebelt, Senior Director of Clinical Development Innovation at Eli Lilly, said the Innovation group evaluates new tools and technologies fairly quickly, but that does not ensure quick adoption across the enterprise.  

She gave two examples of fairly quick adoption of tools that then failed to reach a use tipping point. Using electronic informed consent as an example, she said that reaching full implementation was a hurdle because the solution was never fully incorporated into workflow, she said.

John Oidtman, VP of Clinical Trial Support and Compliance at Pfizer, related the adoption of a tool to do better trial planning. We used it and it worked, he said, but it didn’t change the dialogue.

The timing given in most examples—two years, 18 months—would be “a lifetime for a technology company”, Mahmood.

On behalf of tool providers everywhere, Mahmood asked the panelists what was the “killer app” that they most needed to do their jobs. Every answer had to do with patient services.

David Gillogly, VP and head of global clinical operations at Mylan, called for better patient enrollment apps.

Vandebelt called for better patient support. “We are moving responsibility from nurses and doctors to the patient,” she said. We need to support them, and a help desk is not support.” She called for nurse navigators—already at work guiding patients through the oncology landscape—to be made across clinical research. After hearing Vandebelt’s vision, Oidtman joked, “I was going to say eSource, but I really like Kathy’s idea.”

Mark Travers, Sanofi, called for an app that would guide a patient through the whole trials process, starting with finding a parking space at the hospital.

When it came to innovation, Gillogly was quick to point out that innovation is not the same as novelty. Even if a technology is new, the process needs to be innovative. Real change, he said, starts in processes.

The patient focus continued throughout the event. In the track on enrollment planning and patient recruitment, conversation turned to connecting with patients via social media, and using social listening to understand what your patients need.

Therese Johnsen, manager of Clinical Trial Intelligence at Novartis, highly recommended working with a social media analysis vendor. She mentioned the solutions from Google Analytics, Ice Rocket, Social Mention and Topsy as options. Look for both the patient and the caregiver experience, she said, and be prepared to comb through the data carefully.

And there will be plenty of data to comb through. Joe Kim, now with Eli Lilly, reported that 40% of patients use the internet to help make chronic disease decisions and 75% of patients go online after a diagnosis. Diane Montross of Shire later reported that 100% of rare disease patients report using the internet for health information.

The patients are online having conversations, and Kim advocated for getting out to meet them. “You need to get out of your office and see the whites of their eyes,” he said. “Meet them. Talk to them. Tweet them.”

Taisa (Taya) Skubiak, Associate Director, Global Recruitment & Analytics at Bristol-Myers Squibb, reported that Bristol-Myers engages with patients a year and a half years before trials start, investing in what they view as a valuable relationship.

She recommended working closely with patient advocacy groups. Bristol-Myers Squibb has created a patient advisory forum made up of patients, advocates, and caregivers to inform protocol design, study endpoints, patient reported outcomes, and quality of life.

“We need to be listening, and by listening I mean acting!” Skubiak said. She challenged study designers not only to collect feedback, but use that feedback to carefully interrogate everything about a study including the standard protocol and inclusion and exclusion criteria.

One patient with opinions on study design was Jeri Burtchell, a multiple sclerosis patient and advocate. She challenged sponsors and CROs to take an Apple approach to trial design and offer patients unlimited “apps” or options that they can collect to create a trial experience that is right for them.

Negotiate the essentials, she suggested, and offer incentives for extra data. She recounted an MS trial for which the protocol included five lumbar punctures, and argued that all five weren’t really necessary. Require a baseline and exit procedures and offer incentives for others, she suggested.

Gameify the trial experience; in some cases gold stars for leveling up might be all that’s needed to keep patients engaged and participating, Burtchell said. “But for extra lumbar punctures, I’m going to need cash.”

The Recruitment Question

Patient recruitment is an ongoing theme at SCOPE because it presents such a challenge for clinical operations executives. Pharmas and sponsors still compete on patient enrollment, said Kathy Vandebelt. As long as we compete on enrollment, she said, we’ll still be competing on trials, not our drugs.

It’s a problem at the heart of many of the SCOPE conversations.

Some speakers reported big wins in recruitment thanks to technology tools. Diane Montross reported that Shire partnered with MyHealthTeams and TrialNetworks to reach patients and sites via social media, and in doing so exceeded its online recruitment expectations by 400%.

Other groups are taking advantage of modeling and simulation to build virtual patient cohorts. There’s increasing competition in patient recruitment, said Hui Cao, head of health informatics at AstraZeneca. “Patient pools are so small, it’s almost impossible to randomize.”

With a lack of patients, AstraZeneca is considering simulated virtual placebo arms for studies. The pharma did a feasibility study looking at severe asthma sufferers from the national registry data in Sweden. While a study arm got the drug, the comparison arm tracked the health outcomes of appropriate patients from the registry’s database.

A neat solution for control groups, the idea certainly won’t do away with need for study participants. The real enrollment problem, Joe Kim asserts, is that not enough people care. People prefer a story to care about, Kim said, and when patients feel that they have been “kicked to the curb” after a study is completed with no information or follow up, they are unlikely to share their story and become advocates for the clinical trials process.

For Kim the answer is clear: relationships fill trials.

Looking Forward

Rounding out the last day of SCOPE, Craig Lipset, head of Clinical Innovation at Pfizer, said the real innovation challenge is not coming up with ideas, but implementing them.

Lipset presented his forecasts for clinical operations. Mobile wins, Lipset said. Mobile apps and tools will be essential to clinical trials moving forward. He showed off a Scanadu Scout, a hockey puck-sized device that measures temperature, heart rate, respiratory rate, blood pressure, oxygen saturation in blood and ECG.

EDC is obsolete. Lipset asked for a show of hands in the audience of anyone who disagreed. No one took the bait.

There will be a reduced dependency on trials. Drug design and development is changing, and drug testing will change too.

Finally, patients will have access to more and more data, and they will control what happens to it.

Jeri Burtchell spoke for thousands of patients when she responded on Twitter: YES!