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IMProving Access to Clinical Trials data (IMPACT) Observatory: tracking the evolution of evidence creation

There is increasing demand from numerous constituencies for full transparency of clinical trials (CT) to facilitate re-analysis and secondary analysis. This is expected to increase the reliability of evidence needed for evidence informed decision making in health, and speed knowledge creation. Efforts to overcome existing barriers related to increasing transparency and opening CT data have recently intensified via many initiatives relying on innovative methodologies.

An Observatory or Natural Experiment is the methodology of choice for a assessing such initiatives and consequent transition of CT data sharing and its impact on CTs. As such, an Observatory aims to inform the transition process and indicate trends. The establishment of the IMPACT Observatory included setting of the methodology for assessing the impact on trials of data sharing interventions of different constituencies including: regulators; funders; journals; publishers, researchers; consumers; academia; media, and pharmaceutical industry.

WORKSHOP (half day)

  • Increase understanding the benefits of data sharing, related issues and initiatives. Learn about the relationship between data sharing and research integrity, research waste and knowledge creation.
  • Learn about the observatory/natural experiment as a tool to assess transition of data sharing, indicate trends and thus contribute to increasing the reliability of evidence, control of research waste and speed knowledge creation.
  • Learn about guidelines in the area of clinical trials and trial registration/Hands on.

At the conclusion of the workshop, participants will develop:
  • Understanding the issues around the opening clinical trial data: benefits and obstacles; relationship with research integrity, research waste, and knowledge creation; the impact on research and medical interventions; importance of data management
  • Understanding of an observatory, its application, and the role of the Observatory in changing the paradigm of clinical trials
  • Ability to search WHO- related registries for trial protocol elements, results and characteristics; and to prepare clinical trial protocol registration in WHO related registries
  • Familiarity with clinical trial standards and guidelines and their use; and the use of EQUATOR , SPIRIT, CONSORT, PRIZMA IPD
  • Interest in studies based on existing data
  • Interest in joining the IMPACT Observatory network

    Evidence for decision making
    • Evidence pyramid and knowledge pyramid
    • One study vs systematic review vs pooled analysis
    • Cochrane systematic review and meta-analysis
    • Raw data-IPD-reusable data
    • Trial registration-results reporting and public disclosure of data

    Open clinical trial data
    • Open science and open data
    • Opening clinical trial data – dynamics and Trends
    • Benefits, barriers and facilitators
    • Players

    Data sharing and research
    • Data sharing and research integrity
    • Data sharing and research waste
    • Data sharing and knowledge creation
    • Data sharing and reliability of evidence gathered by the research

    IMPACT Observatory
    • Observatory or natural experiment
    • Choice of observatory as a tool to assess transition in data sharing
    • Development of the IMPACT Observatory (Ottawa statement-PROCTOR-IMPACT)
    • Methodology of IMPACT Observatory
    • Setting of IMPACT Observatory

    Guidelines and standards in clinical trials
    • The role of standards and guidelines in clinical trials
    • EQUATOR; SPIRIT / protocol – CONSORT / results – PRIZMA IPD
    • WHO Trial registration standards
      • Browse the WHO portal and trial registries
      • Finding trials in given area (area of interest)

    Intended Audience: researchers, clinical trialists, methodologists, clinicians, graduate students, health librarians, other health workers, scientific writers, media.

    Required: Participants have to bring their laptops, as hand on exercise is planned.

    Refreshments will be provided at the end of the session.

This course has no current classes. Please join the waiting list