Supportive measures to enhance clinical trial data management in oncology community network practices.

Authors

null

Elizabeth Anne Johnson

McKesson Specialty Health, The Woodlands, TX

Elizabeth Anne Johnson, Jay C. Andersen, Sandy Smith, Bharat Patel, Susan S. Night, Lauren Steckel

Organizations

McKesson Specialty Health, The Woodlands, TX, Compass Onc, Portland, OR

Research Funding

Other

Background: As an innovative industry leader of Research Site Management Organizations, US Oncology Research (USOR) sought to develop a best practice to support over 65 community practice network sites to comply with Sponsor data entry expectations. Efforts led by the Clinical Trial Manager (CTM) focused on bringing research site awareness to priority data, Sponsor deadlines, and weekly performance feedback via the ‘Healthy Data Habits Pathway’. Methods: The Healthy Data Habits Pathway was created to define the role of CTM involvement in data management operations on behalf of USOR. In collaboration with Sponsor, the USOR CTM reviewed data management reports weekly for data entry trends. Results: Two separate oncology clinical trials (different Sponsors) implemented the Pathway with renal and breast oncology indications. The renal trial demonstrated an almost 90% reduction in total query count for 8 sites in 7 months while the breast trial reported 7 of 14 sites (50%) meeting Sponsor goal of 20 or fewer total queries in 13 weeks. Interventions included emailed notifications, site manager calls, and weekly CTM-Sponsor collaboration teleconferences. Conclusions: Clinical research Sponsors and sites both strive towards maintaining data integrity in an ever-evolving atmosphere of complex oncology trials and increasingly-detailed data capture requirements. Implementation of Pathway interventions increases site and Sponsor engagement in daily data management operations.

Healthy Data Habits Pathway
Develop A PlanObtain information regarding proposed Sponsor data management plan and expectations
Identify TrendsCollaborate with the Sponsor study team to identify trends in query resolution and data entry timeliness
Monitor ProgressEncourage open discussion during study team meetings as to site progress
Alert Early and OftenEstablish predictive communication conduits with sites and Sponsor
Communicate TimelinesCommunicate timelines and subsequent expectations for data entry. Obtain site feedback in their ability to meet data deadlines and assist as appropriate. Host a Sponsor post-conference to review and critique data management plan effectiveness.

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Abstract Details

Meeting

2018 ASCO Quality Care Symposium

Session Type

Poster Session

Session Title

Poster Session A: Big Data Studies; Projects Relating to Equity, Value, and Policy

Track

Projects Relating to Equity, Value and Policy,Big Data Studies

Sub Track

Changing Landscape of Provider Organizations

Citation

J Clin Oncol 36, 2018 (suppl 30; abstr 38)

DOI

10.1200/JCO.2018.36.30_suppl.38

Abstract #

38

Poster Bd #

E3

Abstract Disclosures

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