July 2019 Slide of the Month

Background: To provide a framework for discussions at the CIRS June 2019 Workshop, “Approaches to better decision making in companies and regulatory and HTA agencies through documentation, quality decision-making practices and knowledge management,” CIRS undertook a focused survey across major regulatory agencies and companies. Objectives of the survey were to:

  • Identify companies’ and agencies’ current approaches to documentation of decision making for major decisions during the development and review of medicinal products
  • Investigate the perceived value of the documented information regarding the decision and how it is used by companies and agencies
  • Determine what organisations believe should be documented at the time of the decision to correlate the expected outcome at the time of decision with the actual outcome and utilise the learnings for institutional knowledge management to improve future decision making

Methods: Two questionnaires were developed and subsequently piloted for the purpose of content validation. These were sent to major international regulatory agencies and CIRS members companies. Participants were asked to provide responses regarding major decisions undertaken within each organization; eg, the agency decision to approve a medicine or the company decision to submit a dossier to an agency; going from phase II to III.

Results: Responses were obtained from 11 major regulatory agencies in Europe, Americas, the Middle East and Africa as well as 12 major pharmaceutical companies. This slide shows responses to one of the questions (out of 18 in total): a gap analysis was undertaken where each organisation was asked whether they believe their current documentation system was fit for purpose; next, agencies were asked if generally, companies have good documentation in place and companies were asked the same question regarding agencies.

  • In general, both agencies and companies believed that their current documentation system is fit-for purpose. Companies either strongly agreed (4) or agreed (1) or were unsure (5), which may indicate that the purpose of the current system is not clear. Based on the agency response, there was also agreement that the system if fit-for-purpose (5 agreed; 2 strongly agreed).
  • The results of the gap analysis demonstrate that in general, agencies believed that companies document in a transparent manner all the relevant info on which they have based their decision making regarding the development of a medicine (6). Nevertheless, some agencies did not respond to this question and this should be explored further. On the other hand companies believed that agencies, in general, do not document all the relevant info on which they have based their decision making regarding the review of a medicine (6).

Conclusions: In general, findings support the need to further explore this topic to support for more consistent and predictable documentation of decision-making processes during the life cycle of medicines.

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