SCOPE 2014 Final Sessions

SCOPE 2014 Final Sessions

Previously Posted

Day 1, February 4th, 2014
Day 2, AM sessions
Day 2, Part 2
Day 3, Plenary Keynotes

Clinical Finance Can be Fun?

Last week at SCOPE, following the plenary keynotes I headed straight for my good friend, Chris Chan’s session.  A Bay Area buddy and Industry thought-leader, Chris always delivers a fun clinical finance presentation.  Stepping through the ‘Wheel-of-Fortune’ gimme series of letters, R-S-T-L-N-E, Chris amused us all with six easy “wins” for finance. His talk centered around strategies to implement in every trial as “a given”. Control for these and you are  free to figure out the rest of the finance “puzzle”. If you want all 6 tips leave a comment below and I’ll ask Chris to come summarize everything in a new guest post.  Otherwise, you’ll have to settle for just one “free” tip, my favorite tip, “L: Less Material, Lower Impact.” Chris reminds us that every item in a budget cannot receive an equal amount of consideration.  He recommends focusing on the “big bucket” items and setting thresholds and time limits for reviewing/projecting to avoid dragging down the process for smaller items.

Elite Research Network

One AM session last week that I especially enjoyed was co-presented by Janet Christoff of Sanofi and Chris Hoyle of Elite Research Network (a fellow NC State University grad – go Wolfpack!). Over a period of 32 months, they completed 2 flu studies: 9000 subjects were enrolled, 3500+ SAEs were recorded, and over $1.5m was spent just on surveillance phone calls for safety follow-up. Several Elite Research sites were among the 126 total sites that contributed study patients. Chris focused his part of the talk on the differentiating processes that allowed Elite to simultaneously enroll large groups of subjects but adhere to the protocol, safeguard against mis-randomizations, and meet exacting study timelines.  I jotted down several pages of “Lessons Learned” between year 1 and 2 of these trials. The tracking and volume of operational data managed by Janet’s team really left my head spinning and it was instructional to hear about the “real-time” operational adjustments they were able to make during conduct.

Shareable Site Credentials

Al Pacino luncheon presentation

Al Pacino of HealthCarePoint hosted a lunch session to showcase their site HR Management system featuring standardized Personal Experience Training (PET) records. Health care provider credentials can be standardized and sponsors who select connected investigators can benefit in more efficient study start-up. A new collaborator for the Alliance for Clinical Research Excellence and Safety (ACRES), Al is focused on exchange. At ClinOps Toolkit, we value open exchange to optimize clinical trials.

Metrics vs. Patient Engagement

Last Thursday afternoon was tough.  I was feeling information overload and yet I was also completely conflicted on which afternoon track to attend. In the end I decided that I could not miss Dr. Gren Koski as chair of the ‘Measuring Site and Study Quality’ session. Regrettably, that meant I could not attend the ‘Patient Compliance and Retention through Mobile Tech’ track; if you made it to this one please fill me in on everything I missed.

Measuring Site and Study Quality Dr. Koski opened up the final talks of the conference by stating “sites matter, nurture them.” Jane Fang from Intermune walked us through data standards as the key to cross-system integrations. Her specific examples of eClinical dashboard components provided me an excellent foundation for developing modular visualizations and analytics for my team this week back in the office. I will apply what I learned in Senior management/study team updates and managing trial performance.

Marina Malikova of Boston University Medical Center presented “Performance Metrics to Use and Believe”. She insisted on quality throughout conduct. I appreciated her examples of risk score calculations, cycle times and other operational data to collect, and practical tips for setting goals and measuring performance.

Michael Howley, Business Professor at Drexel and the rest of the panel concluded the final SCOPE session with more than a sprinkling of sage advice. Here are some of the best items I heard:

  • Define the business objective before you measure anything. Metrics come later only to enable ability to recommend corrective-course (no recording just for sake of collection).
  • Metrics can drive undesirable behavior. Monitor for these unintended consequences and adjust early.
  • Descriptive statistics and other qualitative data are useful only if you establish parameters to rank and evaluate as normalized data.
  • Metrics become more useful when stratification is applied (group by Phase, therapeutic area, region, etc. to analyze effectively).
  • Develop predictive models to look beyond data collections and averages.

Keep the Conversation Going

I found SCOPE 2014 to be very valuable and I will absolutely consider registering next year’s event in Orlando.  If you attended SCOPE and you have more to add to the conversation, contact me for guest authoring opportunities, leave a comment here, or join in discussion about Clinical Trial Optimization over at the ClinOps Tooklit LinkedIn Group.

Previously

Day 1, SCOPE begins
Day 2, Part I
Day 2, Part II
Day 3, Plenary Keynotes

Final Keynotes #SCOPE2014
eBook: Clinical Trials Patient Recruiting and Retention (Tips for Success)
About The Author

Nadia

Nadia Bracken, lead contributor to the Lead CRA blog and the ClinOps Toolkit blog, is a Clinical Program Manager in the San Francisco Bay Area.

3 Comments

  • Anonymous

    May 17, 2015

    Merely a smiling visitor here to share the love (:,

  • Johne570

    August 19, 2014

    Fantastic website. A lot of useful information here. I’m sending it to a few pals ans also sharing in delicious. And naturally, thank you in your sweat!

  • Nicholas Focil

    February 17, 2014

    Great blog!!

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