Clinical Ops: Highlights From this Year's SCOPE Summit

The clinical trial technological landscape continues to morph, as we are starting to see the emergence of novel technologies and techniques to enhance clinical trial strategies and productivity.  Study site/enrollment optimization, patient engagement, and big data were hot topics at this year’s SCOPE Summit in Miami, FL, last week.

Study Site and Enrollment Optimization
Data management and solutions provider Infinata, Inc. featured its BioPharm Clinical SiteSurvey™ platform, which incorporates a new intelligent Site Feasibility Questionnaire module into the company’s existing BioPharm Clinical online tool. BioPharm Clinical is an open and integrated platform that includes more than 450,000 investigators, and 250,000 study sites globally.  BioPharm Clinical pulls data from clinicaltrials.gov, insurance claims and prescription data (backed by Optum Health), FDA warning letters, publications and much more.

“We wanted to make the site feasibility process faster and smarter,” said Ruth McHenry, managing director of Inifnata. “Building upon BioPharm Clinical’s power and ability to optimize trial success, we integrated SiteSurvey so users can cut through the data migration and the repetition that currently bogs down the feasibility process.

Site Survey also covers a lot of the heavy lifting on the analysis side - by comparing each site’s responses to the ideal answers you’re looking for and developing an overall rank for each site,” McHenry added.

Moreover, BioPharm Clinical creates an investigator Relevancy Score based on a combination of criteria and contains a ‘drill down’ features that enables users to find exactly what they need via advanced visualizations.  Using Biopharm Clinical, Sponsors and CROs can seamlessly select study sites that are likely to enroll and offer high-quality data - particularly within emerging nations in Asia, Eastern Europe and Latin America.

Anolinx exhibited its breakthrough service, which features access to a vast array of Electronic Health Record (EHR) data, and enables sponsors and CROs to not only optimize a protocol’s inclusion/exclusion criteria, but also identify specific patients that fit a protocol’s inclusion/exclusion criteria for enhanced subject enrollment outcomes.  Anolinx has established agreements with large healthcare systems, and has numerous protections in place that are in compliance with HIPAA and federal regulations.  The Anolinx process is simple: sponsors/CROs provide their request to Anolinx, Anolinx defines/runs queries, and then analyzes, validates, and interprets results.  “We can identify actual patients that fit a study’s inclusion/exclusion criteria and their managing physicians,” said Aaron Kamauu, CEO of Anolinx.

Patient Engagement
Christine Pierre from the Society for Clinical Research Sites (SCRS) invited several patients who have partaken in clinical studies to speak to clinical researchers about their experiences.  Many patients expressed concerns regarding lengthy consent forms, and clinical trial complexity.  “I was faced with a 27 paged consent form, and the entire consenting process took 3.5 hours,” said one patient, and another patient said, “I reviewed about 25% of the consent.”  Another patient referred to clinical trials as, “Guinea Pig experiments.” The message that kept resonating with these patients included the notion that they trusted their clinicians, and all of these patients heard about their clinical trials through trusted referral sources, such as advocacy groups and physician referral networks.

Pierre indicated that study teams do not conduct market research on patients, minorities are underrepresented in clinical research, and that study sites are unsustainable because many sites are research naïve.  “We need our own Public Relations to engage patients for clinical research; we need to touch the emotions of patients,” said Pierre.

Big Data in Healthcare
Jamie Heywood from PatientsLikeMe presented analytical data regarding patient centered outcomes, such as correlations between physical and mental health for certain diseases.  Specifically, Heywood demonstrated the power of predictive modeling to estimate the health effects of ALS on death rates. Heywood’s presentation suggests that the introduction of quantification in healthcare enables clinicians, patients and scientists to improve medical outcomes through predictive modeling. For clinical trials, PatientsLikeMe can be used for highly targeted subject enrollment campaigns, as study teams can target patients by matching a protocol’s inclusion/exclusion criteria to what patients report on the PatientsLikeMe platform, such as healthcare information and Geodemographics.

Next year’s SCOPE Summit will be in Orlando, FL.

Moe Alsumidaie is the President & Chief Scientific Officer of Annex Clinical.