By Allison Proffitt and Lee Yuan 

 

February 13, 2014 | With 11 conference tracks at SCOPE—covering everything from electronic data in clinical trials; site selection and feasibility assessment; spending and reporting; post-marketing; patient recruitment, retention, and engagement; and much more—getting a taste of everything is impossible.  

 

But across all sessions, common themes emerged including patient-centricity, cross-industry collaboration, efforts to ease study startup and feasibility assessment, and the prime role of data in all aspects of the clinical trial life cycle.

 

Getting Social  

 

The concept of “social listening” came up across several tracks. Observing what patients discuss on social media is key to better understanding trials and patients, said Craig Lipset, Head of Clinical Innovation at Pfizer. But it’s still unclear, he said, how to do it, and what to do with the information.

 

Lipset said he’s seen patients going to outside doctors to get viral load counts and sharing their data to try to deduce which arm of the trial they are on. He’s seen patients cut their study medication in half and compare the inside of the pills to try to identify placebos.

 

In December, Pfizer launched the Blue Button project, a concerted effort to share trial data with the patients after the trial is over. Pfizer is watching carefully to see how patient use that data, Lipset said, but he was adamant that data sharing is the only option.

 

Nine out of ten patients say they will share their health data with research if they have full access to it, he said. “All we can do is blow that opportunity by losing their trust!”

 

Excluding the patient voice is inviting them to scam the trial because we’re not listening, agreed Carla DeMuro, head of patient reported outcomes for RTI Health Solutions. Only about half of all registration trials use patient reported outcomes, she said, and lobbied for more patient reported outcomes in trials.

 

There is some opportunity to educate patients too, in the best way to discuss their data and experiences. Joe Kim of Shire alongside Ken Getz of CISCRP and Jeri Burtchell, a Patient Advocate and clinical trial participant herself, came together to discuss managing social media chatter in clinical research. 

 

Diagnosed with Multiple Sclerosis, Burtchell shared her first experiences learning about and enrolling in clinical trials. Finding a need for a patient perspective, Burtchell developed an online community. Burtchell cautioned that there was a fine line between sharing clinical trial experience and potentially sharing enough specific patient information to unblind the study. This is where the “Speak Out, But Speaker Smart” campaign came about. Developed in collaboration with CISCRP, the Center for Information & Study on Clinical Research Participation and the healthcare advertising agency Langland, the “Speak Out, But Speak Smart” campaign encourages discussions about clinical trial participation, while educating clinical trial volunteers on how sharing certain information can have unintended consequences. 

 

Common Collaboration 

 

Working with key stakeholders in clinical research was a common thread throughout SCOPE. There were several panel discussions and co-presentations aimed at building partnerships between sponsors and CROs, between sponsors and sites, across departments, and every other imaginable combination of partnership. 

 

In the Aggregate Spend (Sunshine Act) track, a panel with participants from across sponsors, investigators, sites, and third party CROs convened to discuss how clinical ops as a whole was handling the impending reporting of physician payment to the Center for Medicare & Medicaid. The Clinical Trial Forecasting & Project Management track saw several talks focused on creating cross-functional teams to improve project management and speed study start-up. Rhonda Benotti and Wei Li, both of Genentech, emphasized the role of clear communication in creating successful sponsor-CRO partnerships for advancing clinical trials. Brenda Medina and Miriam Cruz, spoke of their previous work with Eisai and aligning their business operations team with clinical ops to enhance the study start-up process.  

 

Michael Jones, senior director of site development at Eli Lilly, encouraged sponsors to engage external trial partners—site staff, pharmacists, radiology—earlier. We do this well scientifically, he said, but not operationally. “Cutting edge” protocols are “operationally killer,” he warned. They’re more complex and difficult to execute but operational input is made too late in the game. 

 

Beyond the challenges to sites, some protocols are designed with no regard for the patients at all. His classic example: a six hour initial visit in a study for adolescent attention deficit hyperactivity disorder. Echoing what Christine Pierre said in the opening keynote session, Jones said that patients should be asked if they would want to participate in a protocol during the design stage, how could it be made better?

 

Give Me Data 

 

In the data tracks, talks centered on making data accessible during and after trials and improving user experience.

In a joint presentation, Anna Kravets and Anita Zubak, both of Merck, discussed the adoption of new clinical trial management systems and training options for trial managers and other users sites. Merck has deployed an off-the-shelf solution, but Kravets and Zubak emphasized how user experience was addressed differently this time to ensure efficient adoption. 

 

When gauging usability, don’t just rely on what people are saying about the tool, they cautioned. Observe them using it. Watch where they have trouble, which modules they aren’t taking advantage of, how they’re using the tool incorrectly. They suggested diary studies, contextual inquiries, and “build your own” workshops to dig further into user experience.

 

Kavets and Zubak also stressed business knowledge training, not simply transactional use training on new tools. When employees’ roles are viewed as simply transactional, they aren’t given enough information to make smart choices, they said.

 

Jomol Mathew, director of clinical and translational informatics at Dana-Farber Cancer Institute, summarized the first application for the Profile Project, the DFCI project to sequence all patients. The informatics framework built to most effectively use that data is the Synergistic Patient and Research Knowledge Systems—SPARKS. It combines data from more than 30 sub-systems spanning clinical, biospecimen, and ‘omics studies and longitudinal outcomes and lets researchers do hypothesis-generating studies, Mathew said.

 

The Profile Results Viewer is the first SPARKS application, prioritizing a physician-centric view, so that physicians can quickly scan the data while working with patients. A pathology-style report presents mutations, meaningfully absent mutations, and pathological interpretations in a format with which physicians are familiar.

 

Barbara Elashoff, CEO of Patient Profiles, challenged the audience to find study data errors before the end of the study. Patient Profiles’ Query Map tool is automated error monitoring, with the rules being inferred from the data itself. The approach offers the best in user experience and data management, she said. 

 

Mary Flack, CEO of Nanobio, also championed real time trial data review, using a paperless approach to risk-based monitoring. She used tools from Clinical Ink, JReview, and Triumph to input and query trial data via tablets. Paperless data entry eliminates a lot of risk, she said, because there’s no transcription or duplication of data and you can ensure more timely and accurate review.

 

For more SCOPE coverage, see the opening keynote session summary and the roundup of external links.