SCOPE 2016: Protocol Quality, Patient Centricity, and Claiming the Future for Clinical Trials

By Allison Proffitt

February 25, 2016 | In one of the plenary keynotes on Wednesday afternoon at the Summit for Clinical Ops Executives in Miami, Fla., Craig Lipset of Pfizer traced the hype cycle for clinical trial technologies. With technologies and opportunities all along the curve―from the Peak of Inflated Expectations through the Trough of Disillusionment to the Plateau of Productivity―Lipset acknowledged that the industry has its work cut out for it. But we can't just wait for the future to arrive, he warned, or it never does. He challenged: Which of these technologies should we not be waiting for?

Fortunately, a record 1,200 SCOPE attendees were digging into the details of the very technologies Lipset highlighted: everything from risk based monitoring, telemedicine, using EHRs in recruitment, and patient-level data sharing, to concierge travel, social listening, site activation and statistics, and data visualization.

The 2016 Best Practices winners fell in line with meeting's buzz. Open source, telemedicine and concierge services entries took top honors from a finalists list of ten entries

Hype CycleThis year, protocol quality was a new refrain, rising to the top of discussion in several tracks. David Nickerson, senior director of portfolio and vendor quality at Pfizer presented the Pfizer Integrated Quality Management Plan (IQMP), an initiative at Pfizer to approve and develop quality plans in conjunction with protocols. Jill Loftiss and Jane Fang of AstraZenca/MedImmune presented AstraZeneca's plan to improve protocol design and decrease amendments. 

Jaydev Thakkar of Amgen cautioned against “paying old insurance” in protocol design: planning against contingencies that once happened instead of thoughtfully considering what the current protocol needs.

Like last year, patient centricity was a major theme, but conversations this year were more developed, exploring how to measure and improve in patient centricity, and not just pay lip service to the idea. 

To create more patient-centric trials, advocates encouraged sponsors to design protocols with diversity in mind. FDA’s Snapshots made appearances on several slides, highlighting the race, ethnicity, and gender bias in clinical trials thus far. Karen Brooks of Adare Pharmaceuticals put it bluntly: If you are working in a clinical area with disparity and you are not planning for diversity in your study pool, you have a problem! 

Data visualization in trials remains a challenge, with some groups struggling to balance the desire for a real-time look at results with the statisticians’ worry that findings will be misinterpreted or misused. Francis Kendall, at Genentech, believes the struggle is worth it. Genentech has been experimenting with several clinical data visualization tools, with a preference for open source options. Genentech has been using R Shiny, SAS, and Spotfire on both ongoing and closed datasets, and has used Shiny on a few FDA filings. “We’re seeing a lot of value as we move toward regulatory filing,” Kendall said. 

Consumer sensors―wearables―were falling toward the Trough of Disillusionment in Craig Lipset’s view of the Hype curve. Lipset and many others at SCOPE are still hopeful about the role of wearables in clinical research, but don't believe the future will lie with commercial devices.

Instead, trials should look to research-grade devices optimized for specific conditions, according to Steven Nathasingh of the Floida-based consultancy Vaxa. Nathasingh relayed surveys of principal investigators and other trial administrators of neurological trials. 97% believed that wearables were useful to their clinical trials, but the landscape of devices considered was extremely fragmented. The survey listed ten devices, and yet 48% of respondents reported using a device not listed.

We can’t eat an elephant in one bite, Nathasingh said. A Fitbit is not the answer; we need to use specific devices designed to deliver “digital biomarkers” for specific conditions. 

News and Notes from the Expo Floor 

Several SCOPE exhibitors made announcements, with new products and collaborations being announced across the floor. Here are a few highlights from our notes:

HealthCarePoint announced BlueCloud 2.0, an update to the networking technology focused on common shareable directories application and common shareable education standards. The new version will revolutionize health collaboration, promised Al O. Pacino, HealthCarePoint’s president. BlueCloud is a free platform that allows organizations to connect and share verifiable information between healthcare and clinical research organizations and their stakeholders via a private secure network. HCP currently provides networking technology to nearly one million healthcare and clinical research professionals, dozens of national and international entities including 42 pharma, biotech, medical device sponsors, 14 clinical research organizations (CROs), 8 IRBs and thousands of healthcare provider organizations, Pacino said. 

BioClinica was excited to discuss the CRO Alliance the company announced in late 2015. The industry so often focuses on sponsors, said Jason Attanucci, Director of CRO business development. BioClinica’s CRO Alliance was created to specifically meet the needs of CROs. The goal of the alliance is to accelerate the adoption of industry-leading eHealth solutions by CROs. 

DrugDev announced the company’s new site selection module at a luncheon presentation on Wednesday. The module builds on TrialNetwork technology to deliver fast and reliable site activation with a single sign-on, sophisticated permissions dashboard.

Comprehend Clinical published its Benchmark Report this week. Based on a survey of over 300 clinical operations professionals, the report highlights challenges facing ClinOps leaders. Among the findings, 80% of the survey respondents said they regularly miss milestones, and every respondent reported spending money to improve milestone achievement. More than half of the respondents reported that their primary clinical operations decisions support system is a spreadsheet, used to keep track of data coming from disparate systems. The main challenges the report highlighted are enrollment, site productivity, and subject compliance. 



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