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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