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Case Study #2

Improving the efficiency and transparency of the communication for
the Clinical Trial Committee through the digital platform

Overview

Clinical trials oversight by a Trial Steering Committee (TSC) is
mandated by Good Clinical Practice. The role of the TSC members may change depending on how well a trial is going, from rubber-stamping when things are going well to being more critical and directive at other times. Regular and on-time discussion and feedback on how to deal with the issue management, as well as regular amendments to the Protocol might influence the overall results of Clinical trials and as the consequence the success of Medicinal Product on the market.

Challenge

Taking into account competing engagement of leading experts
into multiple scientific bodies including numerous Clinical Trials Steering Committees, and the pressure of extensive traveling with additional complications with COVID-19, the solution with an easy connection through the digital platform will help to ensure availability and participation and could become the new approach in organizing the work of Steering Committees. The security and data protection become as one of the key points considering the Confidentiality of such discussion.

Approach

Find digital solution which facilitate the discussion, advice and decision-making process for the regular communication between Steering Committee members and Sponsor of the trial. The platform will notify the members on all inputs they need to provide, tracking if any inputs are missing. MphaR Virtual Advisory Board Platform was chosen to run this event in digital format to collect the advice, evaluation and align on the next steps for the Steering Committee. Improve the efficiency, transparency and quality of interaction.

Agenda

3 Sessions, 7 Steering Committee members
01
Session 1 (3 days)
Pre-read activities: get familiar with all documents
uploaded into E-Library
02
Session 2 (8 days)
Provide feedback on protocol design and e-CRRF using platform
annotation features
03
Session 3 (5 days)
Discussion Forum: Steering Committee members provided
feedback about a critical part of the protocol, evidence data gaps,
and publication plan

What influenced the decision?

  • protection
    Data security and
    Data Protection
  • discussion forum and video call
    Combination
    of Discussion Forum
    and Video Call
  • discussion
    The possibility for experts to work simultaneously on Protocol and publications to provide their comments
  • materials
    Access to supportive
    materials (publications,
    guidelines)

Results

  • 10 times

    higher the speed of interactions and feedback collection

  • 100%

    of materials were reviewed on time

  • 5 times

    higher the efficiency of communications

  • 95%

    Net Promoter Score to use the platform

Ready to get started?