Day 1 of SCOPE

A ClinOps Toolkit blog report from the Summit for Clinical Operations Executives (SCOPE) conference

Day One: The AM Keynotes

lyuan 04feb2014

  • Ken Getz of Tufts and CISCRP kicked off the day reviewing the current climate for operations of clinical trials.  He discussed challenges like the competition we face during feasibility of our potential sites, barriers to communications, increasing trial complexity/cost, CRO fragmentation, and other inefficiencies. Ken predicted that more adaptive trial design, crowd-sourced clinical trials, and other ‘patient centricity” measures would be emerging trends.
  • Nancy Mulligan of UCB continued the discussion and encouraged all attendees to be a part of the “digital community” and pay attention to health tech and blogs (thanks for reading!).
  • Jamie Heywood of Patients Like Me delivered my favorite talk of the day and left me feeling inspired to “quantify everything” but be wary that measurement can actually cause harm if the insights aren’t validated. Public mistrust of clinical trials is uncontrolled, costs of clinical development continue to rise, and process standardization lags. Jamie is clearly a visionary who will prove that we can have perfectly matched control groups in our trial, predictive outcomes, and increased power by targeting therapies. Jamie is motivated to have the right patient, in the the right trial, matched to the right treatment.

Silent Partners Panel

Christine Pierre, of SCRS and RxTrials reminded us to connect, as an industry, to educate patient’s about clinical trials.  She brought together a panel of 4 clinical trial participants to share their path to trial enrollment, their perceived benefits to participating clinical research, and specific issues with clinical trials. The panel agreed that access to trial information needs to be improved and each panelist was critical of the current Informed Consent process. The concept of our patients as partners in clinical research really resonated with me and the discussion felt very genuine.

Meet Nadia from ClinOps Toolkit at SCOPE in Miami Feb 4th, 2014 @ 1:35pm

So much great content, so little time

I have pages and pages of notes and take-aways from this conference. It feels “right-sized” to me.  I was happy to see familiar faces and I have also met with so many experienced and interesting people today. I had sufficient time to tour the exhibits, there were enough breaks to allow for real connections and conversation, and the speaker line-up was excellent.  I am here for 2 more days but I already got my money’s worth (don’t worry, I’ll stick around and submit more reports) – so far, great event.

This conference had 7 sessions running at the same time and I only regret that I could not clone myself to attend talks in the other rooms. Today I missed these but please email me or comment if you had a chance to catch them and can share your impressions:

  • Managing Social Media Chatter in Clinical Research (this one I am particularly sad about missing)
  • The Patient Community Panel
  • Phase IV Operational Excellence by Quintiles
  • Multiple Stakeholders/Better non-Interventional Studies Panel
  • Optum Health’s Data Management Re-Mix

global site selection feasibility track at SCOPE

Site Selection and Global Feasibility

I was glued to my seat in this room all day. I had meant to tear myself away and sneak into other sessions but the content was just too engaging – I couldn’t leave.  All the presentations were wonderful, here is a quick summary of the top 5 for me, in chronological order:

  • Jackie Kent of Eli Lilly encouraged operational input from many cross-functional groups (yes, even our colleagues in clinical materials & supply) early in clinical design; especially in regards to country/site selection.
  • Inspection Readiness and Global Trial Planning by Bruno Gagnon of Biomarin means adequate monitoring oversight, study ambassadors and subject matter experts to advance the trial, solid recruitment plans (and “Stage 2” plans as you track and adjust), complete documentation, and commitment to quality.  In all my feasibility moving forward I will now request “What questions did we forget to ask your site?”
  • Irina Ringler from InVentiv stepped up as a last-minute speaker replacement for an excellent presentation on using historical performance data to create a reliable model for “probability of success” to predict accrual rates and scoring site performance. Sites will be interested in their approach to feasibility using the ViS platform that negates the need to re-ask questions that have been previously answered.
  • Matthew Stumm of BBK gets my vote for slickest slide deck. His message was clear, 80% of doctors with smart phones have medical apps.  You don’t have to build an app but you should work to understand what need the apps fill for your clinicians. Every initiative or plan needs to be tested and to hit your mark you have to iterate.
  • Dr. Dracker, a Principal Investigator and FDA Advisory panel member for pediatric trials delighted us all with a humorous view of our site/sponsor/CRO/vendor relationships; think marriage counseling. He had me in stitches with his hilarious “disclaimer” slide (I’ll post it later this week) and when he flashed a slide that said “Let’s compromise: You do everything I say and I’ll say everything you do.”

I attended Joe Kim from Shire’s Interactive Breakout session at the end of the day “The Back of a Baseball Card: A discussion of key metrics that help define great investigators”.  I requested an infographic from him to summarize the groups suggestions for quantifying speed, efficiency and quality of clinical sites. I’m really looking forward to sharing and reposting what he comes up with once he collates all of the inputs.

My Talk on Site Summary Data and Ranking

cherry blossoms: "cherry pick" your sites

cherry blossoms: “cherry pick” your sites

In my session, I gave specific administrative and operational data we routinely collect by category and advised everyone to weigh and rank their site performance. In accordance with the December 2012 draft guidance from CDER for Site Summary Data for pre-Inspection I emphasized that operations managers should know the risk areas in pivotal trials supporting an NDA. As a final caution I explained that the data you don’t know or didn’t think to measure may be more important than anything you actually captured and evaluated. By sharing your site summaries within your organization and/or to the sites themselves you can come up with other items that may be valuable to measure.  There were some really helpful comments and discussion from the group and I’ll provide the slides here at the ClinOps Toolkit when I get some more downtime.  I am delighted that CHI provided me the opportunity to speak at the event today.

Next

Part I Day 2
Part II Day 2
Plenary Keynotes Day 3
Day 3, Final Sessions

Another ClinOps New Year
Summit for Clinical Ops Executives (SCOPE) Day 2
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.

2 Comments

  • Johna852

    August 10, 2014

    Im genuinely enjoying the style and layout of one’s website. Its a very uncomplicated on the eyes which makes it a great deal much more enjoyable for me to come here and pay a visit to far more typically. Did you hire out a designer to make your theme? Excellent perform! bdbedeeeafgd

  • Lorraine Mercer

    lorraine

    February 10, 2014

    Great summary. Thanks for sharing. Sorry to miss the event.

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