Summit for Clinical Ops Executives (SCOPE) Day 2

Metrics and Magic Bullets

Enrollment Planning and Patient Recruitment

InVentiv Health chaired the AM session in this track and set the stage by explaining that more advanced data analytics and technical capabilities are available but they are not a silver bullet.  Kelly McKee of Merck stepped us through a pilot program for global trial payments via debit card. Lessons learned included producing study payment system FAQs to proactively address site questions, plans to streamline the IRB process, and a commitment to showcase the benefits of the system and encourage use.

Elizabeth Mascherino from Shire ambitiously took on the topic of ‘Text Messaging Recruitment.’ Through the cost-effective pilot campaigns, Shire saw good conversion and a higher % of respondents contributing in referrals versus historical advertising channels. Patients send “seemingly” discrete texts in response to study ads and advance through screening questionnaires through an IRB approved script.  Initiated by the patient, this exchange can happen easily on a bus, in the gym, etc. without the need to find a computer and log on to a webform or make a phone call.  Response times to any email are within 90 minutes on average, phone calls take a minimum of 3 minutes, but most text messages are responded to in as little as 90 seconds. In the planned ex-US pilot Elizabeth’s team will offer text messaging recruitment options from the start of a trial. They aspire to overcome the issues/burden of tracking various campaigns in different systems during the next iteration.

More Clinical Trial Optimization

Dan White of Quintiles and Rachel Edwards of Amgen co-presented their experience collaborating on risk-based monitoring (RBM).  Their goals were to reduce Source Data Verification (SDV), ensure patient safety, and improve data integrity.  All of these goals were realized in a roll-out of the methodology to 14 studies and 23000+ patients at 3500 sites. In the next year, 12 additional studies are planned for initiation in the centralized monitoring model.

Constant communication with sites and re-testing the triggers early and often are essential. By implementing RBM as a key business strategy for most phases, Amgen effectively went “all in” and moved swiftly from concept to execution of the method. The multi-tier data flow process takes advantage of all the traditional edit/sas checks, and manual reviews before proceeding to a Quintiles medical review team in Bangalore that uses built-in visualization and patient profile views followed by a third tier review by Amgen. Breakdowns will happen if there is not continuous cleaning of the data. Dan White referred to the new collaborative approach as “blurring the silos” between different functional teams.

Bits & Bytes & Bites

Nancy Mulligan and Peter Ducker of UBC pointed us towards free data sources.  I’ll be downloading her slides after the event for all the free data source URLs including US Census, NINR/NIH info, Advocacy Group, MedLine, WHO databases, etc. With those data Nancy suggested I can ask pertinent questions that will assist in protocol design and country/site selection:

  • Are there clusters?
  • What is the true age range of my target patient?
  • Are there specific racial characteristics that define the group?
  • What is the best way to “reach” this patient group?

Following an overview of some paid data aggregation sources that provide more advanced segmentation, the audience questioned the absolute utility of these data sources in disease states with “high touch relationships” between practitioner and patient. A session attendee also asked how these data sources can assist insights into the characteristics of the caregivers (those who have greatest influence on clinical trial participant’s decisions to enroll and comply/continue).

Michael Jones from Eli Lilly delivered an excellent session about data-driven feasibility and rightly pointed out that some trials will have more third parties than actual patients interacting with an individual site.  Complexity in the protocol can lead to a disruptive experience for patients in the trial. Lilly aims to understand the patient experience through pre-protocol finalization white-boarding exercise and mock clinical walk-throughs to reality check the duration and timing of study assessments; operational feasibility.  As a solution, Michael suggested crowd-sourcing feedback for clinical scientists through apps distributed to patient advocacy groups and invitations to external sites to comment in what is essentially a “chat room”.

Bill Gwinn of Optum offered a complimentary report to every attendee on the disease state of interest but cautioned that matching patients does not always equate to investigator availability. Claims data, EMR chart reviews, and questionnaires may point you to where the patients are but competitive trials or a low appetite for clinical trial participation may put your planned accrual rates at risk.  It is intuitive though to “fish where the fishes are.”

Ruth McHenry presented during the lunch session and announced the launch of a new site survey product from BioPharm Clinical to qualify and rank sites. The sites verify their own answers and sponsors can set up filters for positive respondents. Internal data sources can be uploaded or integrations can be achieved with CTMS and other systems.

Full Before Lunch

SCOPE dinner cruise hosted by Pharmica had a red carpet, champagne, and beautiful views of Miami.

SCOPE dinner cruise hosted by Pharmica had a red carpet, champagne, and beautiful views of Miami.

After lunch I spent some time on the exhibitor floor, re-connected with former colleagues in the hallways, and attended 5 more sessions.  My day was so full that I am going to have to write up the rest of the summary for you later this week. Tonight I went on a dinner cruise hosted by Pharmica. It was a wonderful experience and I am so glad for the connections I have made at this conference.

A Guest Summary Coming Soon?

Today at SCOPE, the EDC and Site Selection tracks merged into the “Data-Driven Trial Management” sessions and tomorrow things wrap-up with a keynote panel and the final stream of ‘Improving and Measuring Site and Study Quality’. I don’t have much progress to report on my efforts to clone myself in order to attend new sessions. Happily, my “phone-a-friend” strategy was executed pretty effectively and with my friend, Debbie Cote’s help, I now have notes on more sessions than I could have obtained just attending on my own.  I requested a blog summary of her day but she ditched me in favor of a trip to South Beach tonight.  Maybe tomorrow she’ll have some more updates to add here. Possibly after some aspirin.


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

About The Author


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.

1 Comment

  • Lorraine Mercer


    February 10, 2014

    I understand what you mean by cloning yourself. Wish I could have been there and loaded my brain up with all that information until it was full to overflowing. : -)

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