February 2013 Slide of the Month

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  • In the April 2012 CIRS Workshop The patient’s role
    in the benefit-risk assessment for the submission and review of new medicines

    was held in Hampshire, UK.  A Syndicate
    Discussion group agreed that patients can provide insights into the development
    of medicines that may have not been considered by research and development
    teams, including uncovering incentives for patients to participate in clinical
    trials.  http://www.cirsci.org/system/files/private/CIRS_April2012_Workshop_low-res.pdf
  • Patients should be involved throughout the life cycle
    of medicines, but although it is particularly crucial to discover the basic
    unmet needs of these primary stakeholders as early as possible in development;
    this precompetitive time point represents the most significant gap in patient
    input.
  • In considering the methodology for patient
    involvement, the group emphasised the importance of identifying the most
    appropriate group of participants within the patient community, the
    composition, interests and knowledge of which may change throughout the stages
    of product development. Ongoing surveys of patients and representative groups
    can provide valuable insights. For surveys and other points of patient-industry
    contact, liaisons with non-commercial groups within pharmaceutical companies
    should be encouraged, but the use of third-party survey groups and social media
    may represent novel approaches for patient-industry contact to avoid the perception
    of industry influence.
  • In March 2013 CIRS will be taking the discussion of
    potential methodologies forward a Workshop , The  patient’s voice in clinical development: Can
    patients contribute to the benefit-risk assessment of new medicines?
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